Your Best Resource for Accelerating Development, Minimizing Risk, Reducing Cost and Streamlining Production
THE Meeting Place for the
Bioprocessing Industry
Manufacturing Efficiency & Supply Chain Security
Scaling Up from Bench through Commercialization
Cell Culture & Upstream Processing
Recovery & Purification
Conference: October 12-16, 2009
Exhibition: October 13-15, 2009
Raleigh Convention Center • Raleigh, North Carolina
Reinventing Biologics Pharmaceutical
Development and Marketed Product Support
Paul F. McKenzie, Ph.D.
ObamaCare: Stimulus Spending, System Reform
and Market Change
J.D. Kleinke
Future Trends in Biopharmaceutical Operations
and Facilities
Johannes R. Roebers, Ph.D.
Operational Excellence: The Opportunity
in the Life Sciences Industry
G.K. Raju, Ph.D.
Integrating New Technologies in Upstream and
Downstream Processing
Konstantin Konstantinov, Ph.D.
In Pursuit of Quality: Continual Improvement,
Innovation, and Regulatory Oversight
Ali M. Afnán, Ph.D.
Vice President, BIO Pharmaceutical Development and
Marketed Product Support, Centocor R&D
Executive Director, Manufacturing Initiatives,
MIT Center for Biomedical Innovation
Medical Economist and Author,
Oxymorons: The Myth of a U.S. Health Care System
Vice President, Technology Development,
Genzyme Corp.
Senior Vice President, Biologic Strategy, Planning & Operations,
Elan Pharma International Limited, Ireland
Senior Staff Fellow, OPS,
CDER, US FDA
By attending this event with one travel spend, you will gain access to:
• 143 world-renowned presenters to share strategies and lesson learned
• 48 CASE STUDIES from leading biomanufacturing companies of all sizes
• 9 STRATEGIC BREAK-OUT DISCUSSIONS providing invaluable
and uncensored insight for today's critical challenges
• Plenary session on INTEGRATING UPSTREAM AND DOWNSTREAM PROCESSING
• Co-located FORMULATION STRATEGIES for Protein Therapeutics Conference
• 4 pre-conference, IN-DEPTH AND INTERACTIVE SYMPOSIA
• N ew online networking tool to arrange ONE-ON-ONE MEETINGS in advance
• REGULATORY UPDATES that are business critical
• Unmatched networking opportunities with 150+ companies in our
EXPANDED EXHIBIT HALL
• V ACCINE MANUFACTURING TECHNOLOGY Summit
• 2 industry site tours to DIOSYNTH BIOTECHNOLOGY and BIOGEN IDEC
“ BPI is the best conference choice in the biopharmaceutical manufacturing industry.
“
• 1 ,500 bioprocessing scientists, engineers and executives UNDER ONE ROOF
– Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley
Diamond Sponsor:
Platinum Sponsor:
Co-located Event:
Featured Web Partner:
Founding Publication:
Organized by:
www.IBCLifeSciences.com/BPI
Maximize Your Savings and Register Early online or call (800) 390-4078
The Bioprocessing Industry's Premier Event
Who You Will Meet
Conference: October 12-16, 2009
Exhibition: October 13-15, 2009
Raleigh Convention Center • Raleigh, North Carolina
Dear Colleague,
You hold in your hand the key to a week of intensive learning, evocative discussions,
enjoyable networking and solutions to your service, equipment and raw materials needs.
The biopharmaceutical industry has embraced the BioProcess International™ Conference
and Exhibition as its premier event. This is the one place where you know you will have
the opportunity to meet with the key players in the field.
From high-level strategy to nuts and bolts technical case studies, the program digs deep
into important areas where regulatory, technical and market forces are changing the field.
Whether you work with mAbs, recombinant proteins, vaccines, or other types of biologics
– at a large or small company – here you will find presentations and discussions which
will answer your specific information requirements.
BPI takes place in the new Raleigh Convention Center, close to hundreds of biotech and
biopharmaceutical companies in North Carolina's world-famous Research Triangle Park
(RTP) and the greater Mid-Atlantic region. Accommodations are very attractively priced
at the Marriott Hotel, connected to the Convention Center, and the Sheraton, only a
block away.
If you need to stay up to date with the bioprocessing industry, then you need to attend BPI.
Sincerely,
Ellen King
Head, Bioprocessing Series
Barry Walsh
Conference Director and Project Leader
P.S. Remember this is THE Meeting Place of the bioprocessing industry.
Register early to be sure you will have a space and to take advantage of
lowest rates. Call us at 646-895-7445 for attractive team discount offers.
Table of Contents
Pre-Conference Symposia (Monday) . . . . . . . . . . . . . . 5
Strategy Discussion Forums (complete list) . . . . . . . . . 4
Tuesday Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Wednesday Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Diosynth Biotechnology Site Tour . . . . . . . . . . . . . . . . . 9
Thursday Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Biogen Idec Site Tour . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Vaccine Manufacturing Technology Summit . . . 11-12
Friday Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
IBC Professional Training Academy Courses . . . . . . . . 15
Sponsor and Exhibitor Information . . . . . . . . . . . . 16-17
Call for Posters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Venue, Accommodation and Travel Information . . . . 18
Registration Information . . . . . . . . . . . . . . . . . . . . . . . 19
2
Chief Scientific Officers, Vice Presidents, Directors, Managers and Plant
Managers, Heads of Departments, Group/Team/Project Leaders, Senior
Scientists, Engineers, Development and Technical/Application Specialists,
Research Associates, Consultants and Analysts working in the following areas:
• Process Development
• Process Engineering
• Cell Line Development and
Engineering
• Upstream Processing
• Cell and Molecular Sciences
• Protein Sciences
• Media Development
• Technical Operations
• Bioprocess R&D
• Drug Substance Development
• Analytical Development
• Regulatory Compliance/Affairs
• Quality Assurance/Control
• Purification
• Supply Chain
• Manufacturing
• Strategic Planning
• Business Development
What You Will Take Away
• Strategies to optimize capacity utilization and mitigate risk
• Proven approaches to improve product lifecycle management
and minimize risk
• Novel methods to accelerate development and enhance
manufacturability
• Alternative techniques and technologies to de-bottleneck
downstream processing
With So Much Happening at this Event, You Must
Send a Team to Capture All the Information and
Take Full Advantage!
• 2 high-level strategy tracks and 2 cutting-edge technology tracks
• 9 intimate and uncensored strategy discussion forums
• Vaccine Manufacturing Technology Summit
• 4 concurrent pre-conference symposia
• 2 site tours to Diosynth Biotechnology and Biogen Idec
• Access to co-located Formulation Strategies for Protein Therapeutics conference
Expanded Exhibit Hall and Unmatched Networking Opportunities
• Gain access to a worldwide marketplace of 150+ suppliers allowing
you a unique opportunity to explore and evaluate first-hand the
latest technologies, products and services to help you achieve your
company’s development and production goals.
• Have fun connecting with old friends and collaborating with new
partners at networking receptions that are sure to foster new ideas
and solutions you can implement today.
• Choose from 8 themed roundtable discussions that will provide an
informal, relaxed setting for open exchanges with industry experts
and colleagues who share your interests and face similar challenges.
• Join fellow attendees for lively and enjoyable evening networking
dinner. A great opportunity to make new contacts in a relaxed
setting. Space is limited and additional fees apply. Check box on
registration form to sign up.
To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Conference-at-a-Glance
Monday, October 12, 2009
1:00 pm - 5:30 pm
Leveraging Advanced Technologies for Robust,
Efficient Bioproduction and Development
Sponsored by Lonza
Symposium #1: Technology Transfer
Symposium #2: Practical Aspects of Implementing QbD Symposium #3: Driving out Costs from Biomanufacturing
Tuesday, October 13, 2009
Exhibit Hall Opens 5:30 pm - 7:00 pm
Manufacturing Efficiency and Supply Chain Security
8:00 am - 11:45 am
Scaling up from Bench through Commercialization
Supply Chain Integrity, Sourcing, Qualification and Management
Product Lifeycle Management
Strategy Discussion
Forums
Co-Located Formulation Strategies for
Protein Therapeutics
A: A Call for Industrializing
Biomanufacturing: What is Being
Done About It?
Sponsored by Novozymes
Pre-Conference Workshop: The Fundamentals for
Developing Successful Protein Formulations (8:40 am - 12:15 pm)
11:45 am - 12:15 pm
Technology Workshops Sponsored by Diosynth Biotechnology, Irvine Scientific, SynCo Bio Partners
12:15 pm - 1:45 pm
Luncheon Presentation Sponsored by Millipore
The Nuts and Bolts of Quality by Design (QbD)
B: Plant Capacity : Successful
Strategies to Deal with Too Much of It
1:45 pm - 3:30 pm
Disruptive Technologies Shape the Facilities of the Future
4:00 pm - 5:30 pm
Keynote Presentations
Reinventing Biologics Pharmaceutical Development and Marketed Product Support:
Paul McKenzie, Ph.D., Vice President, BIO Pharmaceutical Development and Marketed Product Support, Centocor R&D Operational Excellence: The Opportunity in the Life Sciences Industry: G.K. Raju, Ph.D., Executive Director, Manufacturing Initiatives, MIT Center for Biomedical Innovation
Opening Night Cocktail Reception Sponsored by Diosynth Biotechnology in Exhibit/Poster Hall
5:30 pm - 7:00 pm
Wednesday, October 14, 2009 Exhibit Hall Hours: 9:45 am - 7:15 pm
Manufacturing Efficiency and Supply Chain Security
Scaling up from Bench through Commercialization
Strategy Discussion
Forums
Co-Located Formulation Strategies for
Protein Therapeutics
C: Defining Animal Free for Cell Culture
Based Biotherapeutic Production
Sponsored by BD Biosciences
D: BioSMB™: Open Platform, Fully Disposable, Continuous
Downstream Processing
Sponsored by Tarpon Biosystems Inc.
Overcoming Barriers to High Concentration Protein Formulations
Technology Workshop Sponsored by SAFC Biosciences
7:15 am - 7:45 am
8:00 am - 12:00 pm
Keynote: Overcoming the Physical Barriers for
Delivery of Large Molecules: Henryk Mach, Senior Investigator, Merck Research Laboratories
(1:15 pm)
The Challenges of Measuring and Controlling Visible and Subvisible Particles
(2:00 pm - 5:30 pm)
Technology Workshop Sponsored by Brightwell Technologies
Maximizing Process and Facility Efficiency
Minimizing Variability of Process and Product
Protein Formulations for Prefilled Syringe and
Autoinjector Devices
(8:45 am - 12:45 pm)
Site Tour to Diosynth Biotechnology
8:15 am - 12:00 pm
Technology Workshops Sponsored by Applied Biosystems, DSM Biologics, Invitrogen, Thermo Scientific
12:00 pm - 12:30 pm
Technology Workshop Sponsored by KBI Biopharma
Networking Luncheon in Exhibit/Poster Hall with Dedicated Poster Viewing
12:30 pm - 1:45 pm
1:45 pm - 3:30 pm
Shared Plenary Session - Innovation and Improvement: The New Challenges for Quality and Regulatory
FDA Presentation: Structure and Function of Heparin Polysaccharide Chains: Update on Recent Contamination Issues
FDA Presentation: In Pursuit of Quality: Continual Improvement, Innovation, and Regulatory Oversight
Development of a Monoclonal Antibody Using QbD: Results from the Industry Consortium Case Study
Quality by Design in Formulation Development
(2:10 pm - 2:45 pm)
4:15 pm – 5:45 pm
Keynote Presentations
Future Trends in Biopharmaceutical Operations and Facilities
Johannes Roebers, Ph.D., Senior Vice President, Head of Biologic Strategy, Planning & Operations, Elan Pharmaceutical International Limited, Ireland
ObamaCare: Stimulus Spending, System Reform and Market Change
J.D. Kleinke, Medical Economist and Author, Oxymorons: The Myth of a U.S. Health Care System
The Impact of Excipient Selection on Protein Quality and Stability
(4:30 pm - 5:30 pm)
5:45 pm – 7:15 pm
Networking Cocktail Reception in Exhibit Hall
8:00 pm – 10:00 pm
Make new contacts during a lively networking dinner (optional, space is limited)
Thursday, October 15, 2009 Exhibit Hall Hours: 9:45 am - 3:45 pm
Cell Culture & Upstream Processing
8:00 am – 12:00 pm
Recovery & Purification
Technology Workshop Sponsored by BioSystem Development, LLC
7:15 am – 7:45 am
Strategy Discussion
Forums
Approaches to Reduce Investment and Accelerate Process Development
Innovations in Media Development
Overcoming Bottlenecks in Downstream Processing
Advances in Process Monitoring and Control
High Throughput Formulation Development
E: Adopting New Technology – Take II The Effect of Freezing and Drying on Protein Stability
F: Flexible, Small Scale Manufacturing
Optimizing Analytical Methods for Facility Scenarios
Formulation Development
8:00 am – 11:30 am
Site Tour to Biogen Idec RTP Facility
12:00 pm – 12:30 pm
Technology Workshops Sponsored by BD Biosciences – Advanced Bioprocessing, GE Healthcare, Invitrogen, Tosoh Bioscience LLC Shared Plenary Session – Integrating Upstream & Downstream Processing
Keynote Presentation: Integrating New Technologies in Upstream and Downstream Processing
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corp.
Panel Discussion - What more can be done to Increase the Integration of Upstream and Downstream Processing?
Friday, October 16, 2009 Cell Culture & Upstream Processing
11:45 am – 12:15 pm
12:15 pm –1:45 pm
1:45 pm – 5:00 pm
G: Measurement Uncertainty:
Acknowledging, Analyzing and Managing
Optimizing Analytical Methods for Formulation Development (continued)
Vaccine Manufacturing Technology Summit
Formulation for Novel Protein Therapeutics
Strategy Discussion
Forums
Recovery & Purification
Technology Workshop
7:15 am – 7:45 am
8:00 am – 11:45 am
Technology Workshop Sponsored by Symyx
Networking Luncheon in Exhibit/Poster Hall and themed roundtable discussions
12:30 pm –1:45 pm
1:45 pm – 5:30 pm
Co-Located Formulation Strategies for
Protein Therapeutics
Technologies to Measure and Control Processes
Applications of Genomic, Proteomic and Metabolomic
Technologies – Dealing with all the Data
Applying Analytical Methods in Downstream Processing
Alternatives to Traditional Column Purification
H: Process Validation for the 21st Century
I: Preparation and Planning –
Keys to a Successful Inspection
Technology Workshops Sponsored by Novasep, New Brunswick Scientific, PBS Biotech, Inc.
Luncheon Presentation Sponsored by Pall Life Sciences
Process Quality & Characterization
Scale-Down Models and Scaling Up Case Studies – Lessons Learned
New Approaches and Technologies for Downstream Processing
New Therapeutic Modalities
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
See Page 15 for details
3
2
Comprehensive Tracks
Manufacturing Efficiency and Supply Chain Security
• Gain new perspective for your plans for growth in emerging markets and global clinical
trials by hearing Novartis Biologics’ globalization strategies and considerations for
biopharmaceutical technical development
• Avoid supply interruption by hearing what works and what doesn’t work in risk assessment
techniques and in subcontractor oversight
• Plan your facility of the future by getting a first look at disruptive technologies including cellfree production, cell culture perfusion with sequential multicolumn chromatography and a
100% single use vaccine facility
• Gain maximum output from your process and your facility by hearing how thought leaders
coordinate multiple facilities, and employ operational excellence strategies and disposable
technologies
Scaling up from Bench through Commercialization
• Speed your regulatory approval process after hearing a report on 13 years of experience
with comparability for post-approval changes from Genentech.
• Effectively manage your product’s lifecycle by learning phase appropriate analytical method
progression and knowledge management in support of QbD
• Understand practical ways to implement QbD including demonstration of comparability of
small scale models
• Obtain flexibility to manage your product post-licensure by hearing Genentech’s global
submission strategy using QbD principles
• Minimize process and product variability from cell line through post-approval by learning
cutting edge “omics”, conjugate production, control strategy, and analytics to support
process characterization and validation
Cell Culture & Upstream Processing
• Streamline development with high-throughput strategies for
the efficient selection of high antibody producing
recombinant CHO cell lines
Sponsored by:
• Examine a systematic approach to develop
chemically-defined cell culture platform media
• Optimize a legacy cell-culture process alongside transfer to new facilities
Insightful Plenary Sessions
Current Regulatory and Quality Updates
• FDA Update on New Process Validation Guidance
• Hear FDA updates on how to avoid product recalls through control strategies
and other case study experience with heparin
• Understand regulatory expectations by hearing the industry consortium case
study of development of a mAb using QbD
Integrating Upstream and Downstream Processing
• Hear both perspectives on what more can be done to build a stronger
connection at the process interface
• Take advantage of the parallels in continuous upstream and downstream
manufacturing of proteins and synthetic molecules
8
• Capitalize on bridging knowledge in these two areas, including process design
concepts, new technologies, and logistics
Themed Roundtable Discussions
• QbD: Implementation with Limited Resources
• Extractables and Leachables: Best Practices for Analyzing Data Sets with
Disposables
• Disposables and Sensors: Current Reality and Future Potential
• Disposables: Economics, Regulatory Aspects and Technical Challenges
• Follow-On Proteins: Timeline for US Adoption
• Post-Antibody Products: A Look Ahead
• Raw Materials: Managing and Auditing Vendors
• How to Tackle Sub-Visible Particle Characterization
9
Break-Out Strategy
Discussion Forums
• A Call for Industrializing Biomanufacturing: What is Being Done About It?
• Employ scale-down models to solve large scale problems
• Plant Capacity: Successful Strategies to Deal with Too Much of it
• Apply metabolic flux analysis to process development and
manufacturing-support scenarios
• Defining Animal-Free for Cell Culture-Based Biotherapeutic Production
• BioSMB™: Open Platform, Fully Disposable, Continuous Downstream Processing
• Adopting New Technology – Take II
Recovery & Purification
• Flexible, Small Scale Manufacturing Facility Scenarios
• Utilize high throughput screening approaches to identify potential improvements to platform
purification processes
• Process Validation for the 21st Century
• Measurement Uncertainty: Acknowledging, Analyzing, and Managing
• Leverage manufacturing process data to avoid unacceptable process variability and
implement process improvements when needed
• Apply the latest analytical tools to optimize the development of robust
manufacturing processes
• Review data from an extensive evaluation of a completely new method for antibody purification
applications which could have a profound effect on monoclonal antibody platforms
• Integrate new technologies and approaches to accommodate large-scale multi-product
clinical manufacturing
4
• Navigating the Pathway to Regulatory Approval from Phase I to PAI
“
4
is the one event every year that brings
“allBPI
bioprocessing professionals together.
-- Maninder Hora, Ph.D., Vice President, Product Operations, Facet Biotech Corporation
To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Monday, October 12, 2009 • Pre-Conference Symposia
12:00 Registration
Symposium #2: Practical Aspects of
Implementing Quality by Design (QbD)
Symposium #1:
Technology Transfer for Biopharmaceuticals
1:00 Chairperson Opening Remarks
1:00 Co-Chairpersons’ Introduction to the Symposium
Jean Bender, Ph.D., Senior Engineer, Genentech, Inc.
David H. Reifsnyder, Ph.D., Principal Scientist, Biopharmaceutical Development, Genentech, Inc.
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Eli Lilly and Company
1:10 Scale-Up and Tech Transfer of Bioreactor Production Processes
Claudia Buser, Ph.D., Director, Global Cell Banking, Technology Development, Genzyme Corp. (invited)
1:50 Unique Technical Challenges Encountered
for a Commercial E. Coli Process Transfer
CASE
STUDY
Fermentation processes present a distinctive set of challenges during process transfer. Compared to
animal cell cultures, the fast metabolism of a high cell density E. coli culture heightens the demand
on the fermentor environmental control capability as well as mixing and mass transfer efficiency in
the fermentor. These challenges are enumerated in a case study on the transfer of a commercial E. coli
fermentation process.
Jean (Jingjin) Harms, M.S., Engineer II, Process Research and Development, Genentech, Inc.
2:30 Foreseen and Unforeseen Technical Challenges Encountered in the Multi-Site
Internal/External Transfer of a Drug Substance Manufacturing Process
Technology transfers often lead to proactive process changes to accommodate equipment and/or facility
differences. Unforeseen challenges may arise due to the transferred process and product being more
sensitive to the operating environment (in terms of temperature or flow), or the process having strict
performance parameter acceptance criteria unearthing new understanding of the effects and limitations
of the new facility and equipment. Furthermore, additional characterization work may yield valuable
improvements in process robustness, yield or product quality. Key technical challenges encountered in the
transfer of a drug substance manufacturing process to internal and external sites will be discussed for cell
culture and purification process unit operations.
R. Michael Boychyn, Ph.D., Principal Engineer, Process Development, Amgen Inc.
3:10 Networking Refreshment Break
3:40 Site-to-Site Tech Transfer for Downstream Biopharmaceutical Processing: A Look into the Requirements for a Successful Process Transfer from an External
Client into a CMO Facility
This presentation examines the requirements for technical transfer of a biopharmaceutical process from
an external client into a CMO facility. Process transfer begins with bench scale verification and continues
through the conformance campaigns into commercial manufacturing. Each step along this pathway
presents unique challenges that when handled proactively using the proper tools and resources, result in a
successful transfer.
Katherine Patton, Senior Scientist, Downstream Development, Diosynth Biotechnology, a part of Schering Plough
4:20 Global Implementation of an Improved Manufacturing Process
Corporate partnerships and global operations for Biopharmaceuticals companies have become
common place over the last twenty years, increasing the complexity of manufacturing networks and
technology transfers to those networks. This presentation will focus on development of strategies for, and
management of, a multi-company, multi-site technology transfer as well as lessons learned
John Herberger, Senior Manager, Global Operations, Amgen Inc.
5:00 Audience Interactive Panel Discussion
1:10 Statistical and Risk Assessment in Industry/FDA CRADA Biotech QbD Case Study
CASE
STUDY
The presentation will provide a step-by-step description of statistical and risk assessment approaches
used in the Industry/FDA CRADA Biotech case study. Understand the application of the approaches to
the definition of the process control strategy, scale-up, validation and manufacturing flexibility. Lifecycle
management of validated state and continuous process verification will be discussed in the context of
ASTM E55 WK20498.
Guillermo Miroquesada, Ph.D., Principal Research Scientist, Bioprocess R&D, Eli Lilly and Company
1:50 A Risk-Based Approach to Process Characterization: Translating Quality by
Design Principles into Experimental Designs
The first step in establishing a design space is identifying which parameters must be studied and which
parameters must be studied together in multivariate DOEs. A risk ranking and filtering approach provides
a framework for identifying parameters, listing the assumptions and data supporting the level of risk
associated with each parameter, and establishing the threshold where multivariate studies are required.
Steven Meier, Ph.D., Senior Engineer, Late Stage Cell Culture, Genentech, Inc.
2:30 Utilization of Performance Constraints for Protein Drug Product Manufacturing
Processes: A Case Study in Manufacturing Process Risk Assessment and QbD
In applying QbD to protein drug product manufacturing process, we estimate performance constraints to
understand design space using worst case scenarios derived from statistical analyses with lot release and
stability data. A process challenge study is then performed to identify unit operations posing relatively
high risks to product quality. These results influence FMEA and process characterization. An antibody
product example will be presented.
Ge Jiang, Ph.D., Principal Scientist, Drug Product & Device Development, Amgen Inc.
3:10 Networking Refreshment Break
3:40 For QbD, What Should a Small Company Do and Why?
QbD is seen by some as a “large company” driven initiative. It can, however, benefit small companies in
both technical and business arenas (e.g. aid partnering). QbD can speed time to market; keep program
focus; and help manage risks and knowledge appropriately. To accomplish this, small companies need to
keep it simple and systems should be product lifecycle appropriate.
James Blackwell, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
4:20 Considerations for Application of QbD for Analytical Programs
QbD principles have been traditionally applied during process development and manufacturing to gain
flexibility in anticipation of changes to the manufacturing process. However not much attention has been
to the application of QbD principles to analytical methods. This presentation will discuss what aspects of
QbD are being applied during development of analytical methods, and the anticipated flexibilities gained
by applying these principles.
Siddharth J. Advant, Ph.D., Head, Biotech Sector, Tunnell Consulting
5:00 Panel Discussion
5:30 Close of Symposium
5:30 Close of Symposium
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
5
Monday, October 12, 2009 • Pre-Conference Symposium and Sponsored Session
Leveraging Advanced Technologies for Robust,
Efficient Bioproduction and Development
Symposium #3:
Driving Out Cost from Biomanufacturing
The objectives of this workshop are to:
Sponsored by:
• Provide an overview of the cost structure of biomanufacturing operations
• Review the methodology and approaches taken to economic analysis of bioprocesses
• Examine the opportunities to address cost effectiveness in process development
and manufacturing
• Look at the impact of new developments and their potential to deliver more cost effective processes
1:00 Chairperson’s Opening Remarks
Miriam Monge, Vice President, Marketing & Disposables Implementation, Biopharm Services Ltd,
United Kingdom
1:10 Biological Products Manufacturing: Cost Challenges and Opportunities Now and in the Future
CASE
STUDY
The industry faces pressure to reduce costs in biomanufacturing. Here we examine the nature of those
pressures, the challenges they pose and identify the key cost drivers in our processes. We examine how
through understanding the cost contributors and those factors that influence them throughout the
product lifecycle you can identify and prioritize opportunities for developing cost effective processes.
Andrew Sinclair, President and Founder, Biopharm Services Ltd, United Kingdom
1:50 Cost-Effectiveness Study on Disposable Technology Used in the Transfer of an Antibody Manufacturing Process between Two Production Sites
CASE
STUDY
The cost modeling exercise compared the implementation of disposables in a cell culture pilot plant to a
theoretical traditional stainless steel model in order to determine the savings made by using disposables.
The results confirm that the pilot plant upgrade was a successful implementation of disposable strategies
used in combination with existing facilities.
Aurelie Foulon, Project Engineer, Biotechnology, Cell Culture Production Support, F. Hoffmann-La Roche Ltd., Switzerland
2:30 Process Cost Modeling: Live Demonstration
Using a cost model configured with the latest bioprocess cost and process information, evaluate how to
1) demonstrate the impact of titre Improvements shift of costs to DSP, and see how improvements in DSP
can redress the balance, 2) evaluate alternative expression systems for a given product (MAb vs. Fab) and
3) illustrate the effect of different disposable technologies. Participants will be able direct all aspects of
the session.
Andrew Sinclair, President and Founder, Biopharm Services Ltd, United Kingdom
3:10 Networking Refreshment Break
3:40 A CMO Perspective on Driving out Costs in Biomanufacturing
CASE
STUDY
DSM has applied innovative expression systems and other approaches to achieve
cost-effective, responsive production. Hear case study details on the applications of disposable
technologies including disposable bioreactors and look forward to the potential of continuous process
based around high titre cell culture. The new technological process and product innovations allow
possible reductions of capital expenditures and COG by 75% and 50% respectively, while increasing
flexibility and speed.
Francis B. Maddalo, Vice President, Operations/Facilities Development, DSM Biologics
4:20 Economic Models Guiding Expression System Choices in Early Phase Clinical Development
CASE
STUDY
Early in process development, cost models provide a useful tool for evaluating process design alternatives
such as expression system choice. Preliminary development data can be used to test scenarios that
facilitate resource allocation and provide focus for the project. A Biopharm Services cost model was used
to compare phase I clinical manufacturing process alternatives for a recombinant protein therapeutic,
PRM-151.
W. Scott Willett, Ph.D., Senior Director, Biopharmaceutical Development, Promedior As part of the IBC’s BioProcess International conference, we are pleased to bring you a half-day
technology session featuring Lonza's top in-house technology experts with extensive case studies,
the latest scientific research, and hands-on experience. In this session, we will highlight leading
biomanufacturing procedures, advanced development pathways and key risk mitigation practices
for establishing robust, efficient, high-value bioproduction and development. Speakers will focus on
how to tackle development challenges and leverage the latest technology breakthroughs to establish
industry-leading results. You will also learn about how cutting-edge platforms and step-change
technologies can add high value, mitigate risks, increase speed to market and lower long-term total
cost of goods.
Topics to be presented include:
Development of Cell Lines for cGMP Manufacture: Reducing Timelines
Pharmaceutical companies are seeking to make substantial reductions in the timeline for generating clonal
cell lines. This presentation discusses approaches for reducing cell line development timelines to 23 weeks,
using Lonza’s experience with developing a process for generating clonal GS-CHO cell lines suitable for cGMP
manufacture for illustration.
Adrian Haines, Ph.D., Senior Group Leader, Cell Culture Process Development
Manufacturing ADCs: Potent New Weapons for the Oncology Arsenal
Manufacturing antibody drug conjugates (ADCs) presents a series of unique engineering and chemistry
challenges for even the most experienced biopharmaceutical manufacturer. Safe, high-quality and cost-effective
production requires extensive experience in both biopharmaceuticals and small molecule drug process
development and scale-up, as well as the appropriate procedures and equipment.
Tom Rohrer, Senior Director, ADC and Biochemical Technologies
Finding the Best Fit: Microbial Expression Technologies
Manufacture of recombinant protein biopharmaceuticals has historically been dominated by two expression
platforms (E.coli and S. cerevisiae). However, the diversity of microbially derived products requires a
multiplicity of molecular expression tools to successfully overcome the challenges of productivity, localization
and product structure/integrity. Adapting traditional expression hosts coupled with innovative approaches
to generate powerful new systems results in a molecular toolbox capable of identifying the right expression
system for any protein.
Chris Dale, Ph.D., Head of Microbial Technology
Single-Use Bioreactors: A Flexible Solution
Singe-use Bioreactors present a unique biomanufacturing solution for small-scale and clinical materials
thanks to their flexibility, easy maintenance and cost benefits. The challenges lie in ensuring product
biocomparability, seamless scale-up and technology transfer between stirred bioreactors and single-use
bioreactors while having a thorough understanding of the regulatory impact. In this presentation, Lonza will
address some of these key issues.
Ashley Westlake, Ph.D., Global Director of Technology Transfer
Potelligent® CHOK1SV: A Further Improvement for the GS Gene Expression System™
Antibody-dependent cellular cytotoxicity activity is a critical effector function for many therapeutic antibodies.
This activity is dramatically enhanced by a reduction in core-fucose on the antibody. This talk describes the
development, in collaboration with BioWa Inc., of Potelligent® CHOK1SV cell lines expressing 100% nonfucosylated antibodies, suitable for cGMP manufacture.
Adrian Haines, Ph.D., Senior Group Leader, Cell Culture Process Development
A cocktail reception will immediately follow for delegates who attended the session.
5:00 Audience Interactive Panel Discussion
5:30 Close of Symposium
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
6
Tuesday, October 13, 2009 • Main Conference
7:00 Registration and Coffee
Manufacturing Efficiency
& Supply Chain Security
Scaling Up from Bench
through Commercialization
Supply Chain Integrity, Sourcing,
Qualification and Management
Product Lifecycle Management
8:00 Chairperson’s Remarks
David H. Reifsnyder, Ph.D., Principal Scientist, Biopharmaceutical
Development, Genentech, Inc.
8:00 Chairperson’s Remarks
Jon T. Conary, Ph.D., Senior Director, Manufacturing, Human Genome Sciences, Inc.
8:15 Featured Presentation
8:15 Responsible Oversight in Outsourced Biotechnology
Manufacturing
Outsourcing complex biotechnology production presents unique challenges
to assure responsible oversight of manufacturing. The author will analyze
responsible oversight using the science of System Dynamics. After an initial
discussion of significant oversight variables, the author will demonstrate
how to analyze and use a System Dynamic model to understand the relation
of variables that effect responsible oversight decisions.
Robert Konopacz, Key Account Manager, Global Biopharmaceutical
Operations, Novartis, Switzerland
8:45 Development and Evaluation of a Supply Chain Risk Assessment Methodology
CASE
STUDY
A supply interruption to any market can come from many events ranging
from non-performance of a component supplier to a major disaster at a
manufacturing site. In order to help evaluate and prioritize efforts around
minimizing supply chain risks, an assessment methodology was developed
and piloted to evaluate its utility to the corporation. A summary of the
methodology strengths and areas needing improvement and will be presented.
Armen Nahabedian, Director, Commissioning and Qualification, Wyeth
9:15 Providing Flexibility and Cost Savings through Supply Chain Strategy in Genentech’s Pilot Plant
CASE
STUDY
The industrialization of monoclonal antibody production has increased
the pressure to reduce bioprocess development lead times and costs. This
presentation will give a case study of how the Genentech Pilot Plant has
developed its supply chain strategy to support these objectives through a
strong focus on decreased cost of goods and increased flexibility.
David R. Volk, Manager, Process R&D Pilot Plant, Genentech, Inc.
9:45 Networking Refreshment Break
10:15 Improving Facility Fit: Integrating Process Design with Operational Data
CASE
STUDY
Fitting new processes or products into existing plants is typically evaluated
using chemical mass-balance models. However these 'facility fit' models
are often poor estimators of actual process performance, since they fail to
account for operational issues in the plant. We introduce a framework that
integrates operational plant data into late-stage process design. This allows
a much more accurate view of process fit, speeding technology transfer as
well as accurately estimating key parameters like run rate.
Rick Johnston, Co-Director, Center for Biopharmaceutical Operations,
University of California, Berkeley 10:45 In-Source or Outsource: CMO Concept of Boehringer Ingelheim: What is the Value of In-House Process Development?
Boehringer Ingelheim has established specific state-of-the-art technologies
as a competitive asset of the biopharmaceutical business. A global alliance
network with dedicated process development and manufacturing companies
ensures high flexibility, short timelines and available capacity. A concept will
be presented that allows for success of biopharmaceutical projects, considering
investment burden, complexity in development and manufacturing as well as
risk management, due to attrition rates during clinical development.
Helmut Hoffmann, Ph.D., Vice President, Process Science,
Biopharmaceuticals, Boehringer Ingelheim Pharma GmbH & Co. KG,
Germany
11:15 Globalization Initiatives for Biopharmaceutical
Development and Production
Globalization strategies and considerations for biopharmaceutical technical
development and manufacturing as enablers for global clinical trials and
growth in emerging markets will be analyzed in this presentation.
Yuan Xu, Ph.D., Global Head/VP of Process Sciences, Production and
Quality, Novartis Biologics, Switzerland
7
Comparability Case Studies: Lessons CASE
Learned over 13 Years of Experience STUDY
Strategy Discussion
Forums
The most popular element of all recent IBC programs
are these small group, extremely interactive
conversations focusing on critical industry challenges.
Here is your opportunity to voice your opinion and
question the experts. Each forum is approximately 90
minutes and participation is limited to the first 50 who
arrive. (Workshop Forum G is limited to 30.)
10:15 A: A Call for Industrializing
Biomanufacturing: What is Being
Done About It?
A significant amount of experience has been gained in the 13
years since the regulatory concept of comparability for post- approval changes for biopharmaceutical protein products
was first developed. Lessons learned from experience with multiple products,
including monoclonal antibodies, will be described. Regulatory pathways,
global aspects and supply chain considerations will be discussed.
Mary B. Sliwkowski, Ph.D., Vice President, Regulatory CMC and
Information Systems, Genentech, Inc.
Sponsored by s
Industrialization is essential to achieve more
affordable drugs while improving – and without
compromising – their quality. Industrialization
cannot be added on top of a process, but needs
to permeate all the way through the development
chain, to the very early stages in project research.
This will shorten development times and lead to
robust processes, both of which translate to lower
production costs and improved standardization of
processes and products. The discussion focuses on
strategies companies are using to achieve these goals.
Topics to be discussed:
• Beyond plant efficiencies, what other aspects need
to be addressed to reduce manufacturing costs?
• The innovators: what are they changing to create a
shift in the paradigm?
• Small changes that have a big impact.
Moderator:
Uwe Gottschalk, Ph.D., Vice President,
Purification Technology, Sartorius Stedim
Biotech, Germany
Panelists: To be announced
8:45 Use of Knowledge Management to Support Product
Lifecycle Management and QbD
Processes to produce biopharmaceutical products change over time out
of necessity. Managing that change requires retention and use of essential
knowledge accrued over the lifetime of the product. Aspects of knowledge
management have been and continue to be extensively used throughout
government and industry for that express purpose. The relevance and
utility of existent knowledge management systems and approaches will be
discussed in the context of application to biopharmaceutical development
and manufacture.
Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen
9:15 Micro Scale Chromatography for Scouting and Predictive
Method Development
We have adopted a parallel micro-scale purification platform to screen for
purification leads as well as for method development. Scale up from the
micro-scale (microliter) to bench top (milliliter) scale has proven predictive,
qualitatively and quantitatively. Data from the screening of mammalian
proteins in E. coli and insect cell expression systems will be presented along
with method development case studies.
Bill Gillette, Ph.D., Senior Scientist, Protein Expression Lab,
SAIC-Frederick, Inc.
9:45 Networking Refreshment Break
10:15 Phase Appropriate Analytical Method Progression to
Meet the Needs of the Product Development Lifecycle
To meet the changing product development requirements, various strategies
have been implemented for the development of analytical technology
for the characterization of a protein, specifically monoclonal antibodies
(mAbs). For the analysis of mAbs, a Platform Analytical approach has been
developed. As part of the Analytical Platform, a phase appropriate strategy
for method verification, qualification and validation process was developed
and implemented.
Charles W. Demarest, Director, Analytical R&D, Pfizer
10:45 Analytical Strategy for Late Stage Clinical/Commercial Readiness
While demonstrating product safety is critical for entering Phase I clinical
studies, monitoring additional product specific critical quality attributes
become essential at the late clinical development stage. Regulatory
requirements and knowledge gained during early stages of development
were taken into consideration to identify the analytical needs for Phase
III/commercial stage readiness for a complex glycosylated enzyme product.
The analytical activities selected and specifications strategy will be discussed
during this presentation.
Shanthini Jeyarajah, Manager, Analytical Development, Shire HGT
11:15Advanced Monitoring and Process Control of Biological Processes
This presentation delves into a practitioner viewpoint on multivariate data
analysis and advanced process monitoring as it applies to process validation.
You will also learn about Biogen Idec’s approach to concepts of scale-up
verification through advanced monitoring and analytical techniques.
Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec
Tuesday Highlights for
Formulation Strategies
for Protein Therapeutics
Pre-Conference Workshop:
The Fundamentals for Developing
Successful Protein Formulations
Explore basic understandings of protein science and
behavior that impact the work of the formulation
scientist in responding to the challenges of stability
and aggregation. Speakers from Wyeth, University of
Kansas, Batelle, Genzyme, Ambrx and Novo Nordisk.
Keynote Presentation:
Overcoming the Physical Barriers for
Delivery of Large Molecules
Henryk Mach, Ph.D., Senior Investigator,
Merck Research Laboratories
The Challenges of Measuring and Controlling Visible and Subvisible Particles
In response to new research findings and requests
from regulatory agencies, industry companies must
now demonstrate an understanding of the levels of
subvisible particulates in protein drug products. Hear
an update from the industry working group outlining
current developments, and perspectives from five
research groups working to respond to this emerging
challenge. Speakers from Pfizer, Roche, ImClone,
Immunogen and GlaxoSmithKline.
BPI delegates may attend the sessions of Formulation
Strategies at no additional charge. To view complete
program details and abstracts, please visit the conference
website: www.IBCLifeSciences.com/Formulation
To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Tuesday, October 13, 2009 • Main Conference (continued)
11:45 Concurrent Technology Workshops
Best Practices and Risk Management as Applied to Technology Transfer
Best practices and risk management begin with
product development and mature with the process as it progresses
through the product life cycle. Examples of problems encountered at
different stages along with specific examples will be presented to show
that meticulous planning and execution are of paramount importance to
ensure a seamless transition of processes.
Divya Parekh, Senior Process Engineer, Process Sciences, Diosynth Biotechnology, a part of Schering-Plough Corporation
Clark Harter, Senior Engineer, Process Sciences, Diosynth Biotechnology, a part of Schering-Plough Corporation
Pipeline Management: Impact of Organism on Manufacturing
While the number of products in an average company's pipeline increases,
the costs and time spent per product in terms of process development
and GMP manufacturing need to be reduced. This presentation discusses
the impact the production organism has on pipeline management,
showing that E. coli is not an ideal production organism. Alternatives
can significantly reduce overall timelines and costs, including the cost of
goods for eventual commercial manufacturing.
Marcel Thalen, Ph.D., Scientific Officer, SynCo Bio Partners B.V., The Netherlands
A Platform for rCHO Cell Line Generation and Culture Producing Multiple Grams of mAbs in 12 Weeks
Results from a collaborative program between
Irvine Scientific, Inc., Santa Ana, CA., and
Selexis, S.A., Geneva, Switzerland will be presented. Scott D Storms, Ph.D., Director of Research and Development,
Industry Cell Culture, Irvine Scientific
Pierre-Alain Girod, Ph.D., Group Leader, R&D, Selexis SA, Switzerland
12:15 Luncheon Presentation: Single-use is Here. Are You Ready?
Plastic. You can pay with it, drink out of it and improve your biomanufacturing process with it. Find out how new single-use technologies, systems, products and solutions can lead to
big gains in performance and throughput. We will explore what’s new, what works and what’s next for single-use and how companies can use single-use as a way to optimize their processes.
Andrew Bulpin, Vice President of Upstream Processing, Millipore Corporation and Paul Chapman, Vice President of Downstream Processing, Millipore Corporation
Manufacturing Efficiency
& Supply Chain Security
Scaling Up from Bench
through Commercialization
Disruptive Technologies Shape the Facilities
of the Future
The Nuts and Bolts of Quality by Design (QbD)
Strategy Discussion
Forums
1:45 B: Plant Capacity: Successful Strategies
to Deal with Too Much of It
1:45 Chairperson’s Remarks
As process efficiencies increase and funding becomes
harder to find, companies are looking for ways to fully
utilize/capitalize their manufacturing assets (facilities
and people). Approaches range from seeking external
projects (partnering, contract services, government
contracting) to pursuing flexible operations to
accommodate more internal projects with existing
resources. This discussion focuses on the strategies
companies are using to fully utilize their capacity and
the challenges that these strategies introduce.
• How companies have increased efficiency/flexibility to
handle more internal projects with existing resources
• How companies have found and closed external
relationships for capacity utilization
• How companies have managed external projects in
your facility and the challenges these have presented
• How companies have used alternative opportunities
for capacity utilization (government etc.) and the
issues these have presented
Moderator:
Peter Latham, President, BioPharm Services US
Panelists:
Lisa Cozza, Senior Director, Manufacturing Alliances,
Human Genome Sciences, Inc.
Dr. Jan Feuser, Associate Director, Pilot Plant
Downstream, Boehringer Ingelheim GmbH & Co. KG, Germany
Robert V. House, Ph.D., President,
DynPort Vaccine Company LLC
Robert Konopacz, Key Account Manager, Global
Biopharmaceutical Operations, Novartis, Switzerland
Jenifer L. Wheat, Senior Director, Commercial
Development, Diosynth Biotechnology, a part of
Schering-Plough Corporation
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Eli Lilly and Company
1:45 Chairperson’s Remarks
James M. Robinson, Vice President Technical and Quality Operations,
Novavax, Inc.
2:00 The Future of Biologics Manufacturing
Several technologies have recently been developed and investigated that can
potentially revolutionize manufacturing facilities and processes. A new toolbox of
technologies may allow for significantly less expensive and more modular facilities
which can match production needs just in time. Portable clean room technology,
cell culture perfusion for production, sequential multicolumn chromatography, and
extensive in-line dilution of buffer concentrates will be particularly useful for small
to mid-size biologics companies.
Timothy Matthews, Senior Engineer, Group Leader, Process Development
Engineering, Genentech, Inc.
2:30 Cell-Free Production of Pharmaceutical Proteins
We have demonstrated linear scalability of an E. coli based, batch mode,
cell-free protein expression system to 100L. Standard process equipment
and low cost energy sources are used. The protein produced is fully
bioactive and of high quality. The protein can be recovered by conventional
means. Rapid transition from research to production is feasible.
Henry Heinsohn, Vice President, Development and Manufacturing, Sutro
Biopharma, Inc.
3:00 Demonstrating an Influenza Manufacturing Process with
100% Single-Use Systems
Novavax is operating a pilot plant facility that is capable of producing 10M
doses of pandemic influenza vaccine in 6 months for a small capital investment
using single-use manufacturing systems. This facility demonstrates the process
capabilities, the low cost and speed of establishing capacity, and the ability to
construct an in-border vaccine solution.
James M. Robinson, Vice President Technical and Quality Operations,
Novavax, Inc.
3:30 Networking Refreshment Break
2:00 Challenges Faced while Developing a Small-Scale Model for a Perfusion-Based Cell Culture Bioreactor Process
CASE
STUDY
This talk will focus on the approach used to demonstrate comparability between
commercial and lab-scale bioreactor processes. The discussion will include
selection of appropriate process parameters and measures of product quality
and will conclude with a comparison of approaches between small-scale model
development for cell culture and affinity chromatography.
Jayanth Sridhar, Ph.D., Associate Director, Cell Culture Manufacturing
Sciences, BioMarin Pharmaceutical Inc.
2:30 Application of Multivariate Analysis as a Scale Down and
Batch Verification Tool
This presentation will outline how a multivariate approach can be used to
qualify a scale down model needed for conducting statistically designed bench
scale studies targeted to understand the effect of various inputs. This approach,
based on PCA (Principal Component Analysis), together with PLS (Projection
to Latent Structures) can be used to to define the allowable space for batch
evolution and can be effectively used to monitor and control the bioprocess.
Sanjeev Ahuja, Ph.D., Senior Scientist, Process Cell Culture, MedImmune LLC
3:00 Submission Strategy for a QbD-Based License Application
QbD is a science- and risk-based approach to developing
in-depth product and process understanding. QbD will
streamline process development and allow companies
to self-manage many types of post-approval changes.
To obtain more flexibility to manage a product post-licensure, product
and process understanding must be clearly demonstrated in the license
application. In this presentation, the submission strategy being taken with a
product being filed globally including QbD principles will be discussed.
Ron Taticek, Ph.D., Director, Regulatory CMC, Genentech, Inc.
3:30 Networking Refreshment Break
3:35
Sponsored by
3:30 Networking Refreshment Break
Event Introduction and Welcome from North Carolina Biotechnology Center
Bill O. Bullock, Vice President, Bioscience Industrial Development, North Carolina Biotechnology Center Keynote Presentations
4:00 Reinventing Biologics Pharmaceutical Development
and Marketed Product Support
Today’s development groups are tasked with moving diverse and complex pipelines
forward in record time with undivided attention required for both product quality and
safety as well as cost of manufacturing. These challenges don’t require incremental
change in the development operating model but revolutionary change in our model.
In this talk, we will discuss activities ongoing at Centocor to meet these challenges. We will discuss the
changes required for the processes, plants and people to ensure successful commercial products.
Paul F. McKenzie, Vice President, BIO Pharmaceutical Development and Marketed Product Support,
Centocor R&D
5:30
4:45Operational Excellence: The Opportunity in the Life Sciences Industry
In this presentation, the speaker will describe the operational excellence opportunity in the
life science industry. A “science” perspective to:
• Highlight the Strategic Role of Operations
• Describe its Current State (“Here”)
• Envision its Desired Future State (“There”)
• Identify barriers in getting from “Here” to “There”
• Summarize Current Approaches to Overcome These Barriers
Initiatives such as PAT and QbD will be put into this context.
G.K. Raju, Ph.D., Executive Director, Manufacturing Initiatives, MIT Center for Biomedical Innovation
Opening Night Cocktail Reception in the Exhibit and Poster Hall Sponsored by
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
8
Wednesday, October 14, 2009 • Main Conference
7:00 Registration and Coffee
7:15 Technology Workshop
Defining Hydrolysates: An Approach for Generating a Chemically Defined Alternative
Hydrolysates are used in cell culture processes as components of a complete medium formulation or part of a feeding supplement for fed-batch bioreactor processes. Due to the undefined nature of
hydrolysates, there is a push to develop a chemically defined alternative. The data will be results of studies performed to elucidate the essential components of commercially available hydrolysates. Zachary W. Deeds, Senior R&D Scientist, Cell Sciences & Development, SAFC Biosciences®.
Manufacturing Efficiency
& Supply Chain Security
Scaling Up from Bench
through Commercialization
Strategy Discussion
Forums
Maximizing Process and Facility Efficiency
Minimizing Variability of Process and Product
The most popular element of all recent IBC programs
are these small group, extremely interactive
conversations focusing on critical industry challenges.
Here is your opportunity to voice your opinion and
question the experts. Each forum is approximately 90
minutes and participation is limited to the first 50 who
arrive. (Workshop Forum G is limited to 30.)
8:00 Chairperson’s Remarks
Wolfgang Noe, Ph.D., Vice President, Strategic Development and Technical
Alliance, Biogen Idec
8:15 Strategies for Disposable Usage at Mid and Large Scale
Downstream Processing at Boehringer Ingelheim
The presentation will analyze the types of disposables used at Boehringer
Ingelheim in biopharmaceuticals at different scales in downstream
including the rationale for usage and their risks and benefits. Hear reports
of storage of buffers and bulks and their limitations, the BI concept for
extractables and leachables, and requests to the suppliers of disposables
from the viewpoint of the operating industry.
Dr. Jan Feuser, Associate Director, Pilot Plant Downstream, Boehringer Ingelheim GmbH & Co. KG, Germany
8:45 An Analysis of Technology Gaps in the Ellen L. McCormick, Director, BioProcess R&D, Pfizer, Inc
8:15 “Omics” Technologies for Cell and Process Development
Despite the various positive features, further improvements are expected
by understanding the biology and responses of Chinese Hamster Ovary
(CHO) cells in bioreactors in more detail. In this paper we report strategies
and results of CHO gene expression profiling experiments. The aim is to
systematically collect “Omics” data from cell lines under various conditions
and to investigate the impact on product quality, quantity, and reproducibility.
Wolfgang E. Budach, Ph.D., Fellow, Bioprocess Development,
Novartis Pharma AG, Switzerland
8:45 ImmunoGen’s Approach to Conjugate Production Processes
Biopharmaceutical Industry
The manufacturing of biotherapeutics, based on cell culture technology, has
been a success story for more than 20 years. Impressive progress has been
made during that time in all involved faculties (cell culture, purification,
formulation) and in our knowledge of the corresponding protein products.
This presentation will focus on a recent survey with industry opinion
leaders on “technology gaps” which may still exist despite efforts in
technology development for cell culture based systems over the past years.
Wolfgang Noe, Ph.D., Vice President, Strategic Development and Technical
Alliance, Biogen Idec
9:15 Effective Long-Range Capacity Planning and Decision Making
As biotechnology companies have grown, the challenges associated with
managing their manufacturing capacity have grown as well. Genentech
has put in place a number of processes to assure timely and robust decision
making for its drug product and drug substance production network. Key
learnings around productivity improvements, the balance between outsourcing and in house production and other critical questions will be shared.
Robert L. Larson, Director, GT Strategic Planning, Genentech, Inc.
9:45 Networking Refreshment Break
CASE
STUDY
ImmunoGen develops conjugates consisting of one of its proprietary derivatives of
the cytotoxic agent maytansine attached to tumor-targeting antibodies. The process
for producing these conjugates is key to reliable achievement of essential product
attributes. A case study is presented on the development of a production process
that consistently and cost-effectively achieves necessary product attributes.
Deborah Meshulam, Director, Process Science and Engineering,
ImmunoGen, Inc.
9:15 Controlling Variation across the Development / Manufacturing Interface
CASE
STUDY
The control strategy is the mechanism by which variation is controlled in
a manufacturing process. Recently ISPE has proposed a three-level model
for such control strategies. This approach places particular emphasis on the
interfaces between each level. This presentation will discuss the interface
at the process/equipment interface. In particular it will discuss how unit
operation capability is being used to ensure that the requirements of the
process are synchronized with the capability of the equipment, thereby
increasing the assurance of in control and capable commercial operations.
Bernard M. McGarvey, Ph.D., Engineering Advisor, Eli Lilly and Company
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
10:30 Facility Optimization: Experience of a Custom Contract
Manufacturer from Broad Scope to the Details
Effective facility utilization begins at the highest level with broad feasibility
analysis of short and long term program requirements well before program
commitment. It continues through logistics planning in support of evolving
product forecasts and culminates with operational excellence planning at
a finer level of detail, such as reducing turn around time for test results in
analytical laboratories.
Jenifer L. Wheat, Senior Director, Commercial Development,
Diosynth Biotechnology, a part of Schering-Plough Corporation
11:00 A Case Study on Technical Transfer with an Emphasis on Risk Management for Improved
Process Robustness and Reliability
CASE
STUDY Talecris Biotherapeutics, a global biotherapeutic company that discovers,
develops and produces critical care treatments for people with life-threatening
disorders, has developed a modified process for production of Prolastin® to treat
Alpha1-antitrypsin deficiency. This case study will cover elements of quality by
design, failure modes and effects analyses, pathogen safety risk assessment, and
document error-proofing for improved process robustness and reliability.
Doug Burns, Ph.D., Manager, Technical Operations Support, Process
Development and Technology, Talecris Biotherapeutics
11:30 Generic Biotechnology: Are Discussions Scientific or Political?
Arguments about "the new boy on the block" ...generic biotechs...are more
political than scientific. More than twenty-five generic companies in Europe
and Southeast Asia are meeting regulatory requirements and several are
marketing products. Current proposed legislation provides acceptable
scientific criteria to move ahead. One generic biotech company, in its
preliminary batches, created enough product by its innovations in product
and procedure to unexpectedly provide for the entire first round of sales.
William Haddad, Chairman and CEO, Biogenerics, Inc.
9
8:00 Chairperson’s Remarks
in Exhibit and Poster Hall
10:30 Integration of Simcell™ Micro Bioreactor CASE
STUDY Automation with On-line Analytics toward
Cost Effective Statistical Process Development Screening
Multivariate experiments are essential to deeper understanding of cell
culture processes. Simcell with associated HTS analytics enables relevant,
statistically valid experiments to be done efficiently. Data rich Simcell
experiments serve to prioritize interactions for confirmation at larger scale,
whereby variation can be minimized if the interactions among process
parameters are known, monitored and controlled.
Russell H. Robins, Research Fellow, Pfizer
11:00 Creation of a Well-Characterized Small-Scale Model for High-Throughput Process Development
CASE
STUDY
Streamlining process development has been the focus of the biotechnology
industry over the last several years. We will discuss our characterization
strategy for 2L, 15L, and 110L bioreactors. We will present a case study in
which the characterization information in conjunction with specific oxygen
uptake rate (OUR) successfully predicted large scale reactor performance.
David Zhang, Ph.D., Scientist I, Upstream Process Development, Diosynth
Biotechnology, a part of Schering-Plough Corporation
11:30 Analytics to Support Process Characterization and Validation
An important consideration to establish an acceptable process design space is
the effect of changing process variables on the product quality. This presentation
will discuss strategies to employ faster alternative assays compared to the lot
release methods to assess this impact, thus enabling the selection of process
parameters to ensure the manufacture of API with suitable product quality.
Mary E. M. Cromwell, Ph.D., Associate Director and Senior Scientist,
Protein Analytical Chemistry, Genentech, Inc.
8:00C: Defining Animal Free for Cell Culture
Based Biotherapeutic Production: Aspects
and Considerations for Today and Tomorrow
Sponsored by
Cell culture medium is a critical ancillary material used
in any cell culture based biomanufacturing process.
Each manufacturer needs to fully investigate and
understand the level of risk associated with all media
components. This is particularly true with regard to
careful evaluation of components defined as “Animal
Component Free” or “Animal Free”, since no industry
or regulatory standard definition currently exists. This
panel discussion will focus on current industry practice
and applications from both the supplier and end user
perspective as well as explore future requirements.
Moderator:
Michael J. Titus, Ph.D., Director,
Quality Assurance & Regulatory Compliance,
BD Biosciences - Advanced Bioprocessing
Panelists:
Soverin Karmiol, Ph.D., R& D Manager, Media
Component Research, Cell Sciences and Development,
SAFC Biosciences
Fredrika McDevitt, Associate Director, Product Quality
Management, Biogen Idec
Bryan Monroe, Ph.D., Process Science Fellow, Process
Sciences, Invitrogen Corporation
Richard N. Schicho, Ph.D., Associate Director,
Manufacturing, Bristol-Myers Squibb Company
Darin J. Weber, Ph.D. , Senior Consultant, Biologicals
Consulting Group, Inc.
9:45 Networking Refreshment Break
10:30D: BioSMB™: Open Platform, Fully Disposable, Continuous Downstream Processing
Sponsored by
Multi-column simulated moving bed separations are
known to increase manufacturing
efficiency and decrease overall downstream costs and
buffer use. The principles of SMB can be applied to many
separation devices including pre-packed chromatography
columns, membrane adsorbers, monolith and EBA
(expanded bed) technology. During this panel,
applications using fully disposable fluid paths for each of
these modalities will be presented and discussed.
Moderator:
Marc Bisschops, Ph.D., Tarpon Biosystems, Inc
Panelists:
James M. Robinson, Vice President Technical and
Quality Operations Novavax, Inc.
Scott Fulton, M.S., Chief Executive Officer, BioSystem
Development, LLC
Ales Strancar, Ph.D., Managing Director,
BIA Separations
To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Wednesday, October 14, 2009 • Main Conference
12:00 Concurrent Technology Workshops
Nutrient Supplementation Strategies in a High Throughput World
Nutrient supplementation has traditionally been employed to replace depleted
media components to extend productive culture lifespan. Frequently 10X concentrates of whole basal media
formulations are used resulting in hyper-osmolality. This workshop examines proven approaches to nutrient
supplement design, screening, bioreactor-based feeding strategies and process parameter optimization. Both
commercial nutrient supplements and custom formulation development work flows will be presented, including
nutrient utilization studies and Design-of-Experiment (DoE) methods in flask culture, bioreactors and the
SimCell™ high-throughput microfluidic system.
David (Xiaojian) Zhao, Ph.D., Technical Area Manager, Research & Development, Life Technologies
POROS® Chromatography Media: A Tool for High-Performance Downstream Purification Solutions
The features and benefits of POROS® chromatography media as they relate to improving downstream purification
process performance and productivity will be discussed. Performance benchmarking of a new high capacity
cation exchange media and other POROS medias will be highlighted. Applications data and process productivity
modeling will be used to demonstrate the benefits of utilizing POROS media for purification unit operations.
Christine Gebski, M.S., Director, POROS Applications and R&D, Applied Biosystems
Technical and Economic Considerations Regarding Design and Application of Single Use Mixing Systems
Bioprocessing mixing operations represent some of the most challenging applications of single-use technology.
This presentation examines the design of Thermo Scientific HyClone Single-Use Mixer (S.U.M.) systems based on
stirred-tank principles and other commercially available conventional and single-use mixing technologies using
computational fluid dynamics (CFD) and 3D animations of methods of use. Technical and economic guidance is
given on selection of systems for applications ranging from simple rehydration of cell culture media to preparation of
critical sterile solutions. Case study results will be presented to demonstrate expected process times.
Cory J. Card, M.S., Associate Director, Cell Culture R&D,
Thermo Fisher Scientific
Moving to the Next Generation of Manufacturing
Biopharmaceuticals are the most successful product group in the Pharma industry
with the challenge producing them cost effectively. DSM Biologics has developed the XD®, Extreme Density process
addressing this. The XD® technology boosts the titer and bioreactor output by a factor 5 - 10 for CHO, PER.C6®
and other cell-lines for both high and low producing clones. XD® can be applied on existing bioreactors with minor
modifications while maintaining good product quality.
Rolf Douwenga, Vice President, Global R&D, DSM Biologics
12:30 Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters to be available for discussions.
Plenary Session – Regulatory and Quality Updates
2:00Chairperson’s Remarks
Jeffrey C. Baker, Ph.D., Senior Director, Manufacturing Sciences, MedImmune
2:15 Structure and Function of Heparin Polysaccharide Chains: Update on Recent Contamination Issues
Heparin has been receiving much attention lately due to a contamination issue with
oversulfated chondroitin sulfate that was brought to light in 2008. This discussion will
highlight some of the underlying structural features of heparin and how the highly
sulfated and negatively charged polysaccharide chains contribute to biological activity.
Ali Al-Hakim, Ph.D., Branch Chief, Office of New Drug Quality Assessment, CDER, US FDA
2:45 In Pursuit of Quality: Continual Improvement, Innovation, and Regulatory Oversight
A culture of quality for pharmaceutical development and manufacturing requires
continual assessing, learning and implementing, from design to packaging.
Fundamental to all the areas are knowledge management, continual improvement,
optimization and innovation. The industry’s research and development sector has
championed innovation for decades; however, the manufacturing and quality assurance sector have not
had the same attention. With regulators being open to innovation and continual improvement and the
current worldwide financial situation, the time and milieu for a step change is most propitious.
Ali M. Afnán, Ph.D., Senior Staff Fellow, OPS, CDER, US FDA
3:15 Development of a Monoclonal Antibody Using QbD: CASE
Results from the Industry Consortium Case Study STUDY A consortium of biopharmaceutical companies have developed a case study detailing
the use of QbD principles, tools and practical examples based on a model monoclonal
antibody. Sufficient detail will be presented to guide the path from Target Product
Profile to process characterization and scale-up. The case study received feedback from
FDA leads and moves the dialog beyond recent general QbD discussions to a more concrete proposal for
lifecycle knowledge management.
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Eli Lilly and Company
Site Tour to Diosynth Biotechnology • 8:15 am - 12:00 pm
Diosynth Biotechnology, a full-service cGMP
contract manufacturer of complex recombinant
proteins, invites you to tour our state-of-theart manufacturing facility in Research Triangle
Park, NC! During the tour you will view the
microbial and mammalian fermentation halls, recovery and purification areas,
media/buffer preparation and QC/analytical laboratories where more than 80 clinical
and commercial products have been successfully developed, scaled-up and produced
for numerous clinical trials and commercial sale. The facilities are licensed by CDER/
CBER, HPB, EMEA and certified by the JMHLW. Light refreshments will be served.
The buses will depart convention center at 8:15 am on Wednesday,
October 14 and return by 12:00 pm.
Diosynth Biotechnology is part of Schering-Plough Corporation.
Space is limited and available on a first come, first served basis.
Please indicate on registration form if you wish to attend.
3:45 Networking Refreshment Break in Exhibit and Poster Hall
Keynote Presentations
4:15 Future Trends in Biopharmaceutical Operations and Facilities
This presentation will analyze current and future biopharmaceutical products and
review history and technology trends in process development and operations. Based
on these analyses and trends, potential conclusions will be drawn for the future of
biopharmaceutical operations, manufacturing capacity and manufacturing technology.
Finally, the impact of these trends on design, cost and operation of biopharmaceutical
facilities will be discussed.
Johannes R. Roebers, Ph.D., Senior Vice President, Biologic Strategy, Planning & Operations, Elan Pharma International Limited, Ireland
5:00 ObamaCare: Stimulus Spending, System Reform and Market Change
Could it happen this time? Decades of a hybrid private market and government health
care system have resulted in one of the most costly and least efficient health care systems
in the world. Combine this moment with a renewed belief that government may be able
to fix what deregulated markets cannot, and serious, systemic health reform may be
signed into federal law by the end of 2009. What will the plan look like? Will it work? What does it mean
for the pharmaceutical industry and particularly biotech drugs? This keynote session examines probable
new policies and outcomes for the pharmaceutical industry under ObamaCare.
J.D. Kleinke, Medical Economist and Author, Oxymorons: The Myth of a U.S. Health Care System
5:45 Networking Cocktail Reception in Exhibit and Poster Hall
8:00 Optional: Networking Dinner
Space is limited. Additional fees apply.
Wednesday Highlights for Formulation Strategies for Protein Therapeutics
Overcoming Barriers to High Concentration Protein Formulations
Hear strategies for overcoming the major challenges of formulating products with high and very high protein
concentrations. Learn how to resolve issues with subcutaneous delivery, aggregation, liquid and lyophilized
formulations and increasing concentration thresholds. Speakers from Wyeth, Halozyme Therapeutics and Allergan
Protein Formulations for Prefilled Syringe and Autoinjector Devices
Explore comprehensive approaches for developing formulations to be used in delivery devices used to facilitate
patient convenience. Explore responses to silicon oil, tungsten, viscosity, syringe functionality, components and
technology transfers. Speakers from MedImmune and Wyeth
Quality by Design in Formulation Development
Learn how to apply Quality by Design approaches to different stages of formulation development and to the
different drivers of formulations, including excipient selection, product form and choice of container/closure.
Speakers from Biogen Idec and Pfizer
The Impact of Excipient Selection on Protein Quality and Stability
Improve your knowledge of the degradation impact of common excipients and excipients coming from
secondary sources. Speakers from Roche and Human Genome Sciences
BPI delegates may attend the sessions of Formulation Strategies at no additional charge. To view complete
program details and abstracts, please visit the conference website: www.IBCLifeSciences.com/Formulation
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
10
Thursday, October 15, 2009 • Main Conference
7:00 Registration and Coffee
7:15 Technology Workshop
AssayMAP™ - A New Platform Enabling Rapid, High Throughput Bioprocess Analytics
AssayMAP is a new system based on disposable micro-chromatography cartridges packed with a wide range of resins, designed for use in automated liquid handling systems or a high throughput spin column format.
Key applications in bioprocessing include high precision product titer in cell culture or downstream (up to 384 results in <30 minutes with no robotics), automated, high sensitivity process impurity ELISAs (96 results in
<30 minutes), product variant analysis and chromatography design space experiments.
Scott P. Fulton, CEO, BioSystem Development, LLC
Cell Culture & Upstream Processing
Recovery & Purification
Strategy Discussion Forums
8:00 Track Sponsor’s Introductions
8:00 Chairperson’s Opening Remarks
8:05 Chairperson’s Opening Remarks
Overcoming Bottlenecks in Downstream Processing
Sanchayita Ghose, Ph.D., Manager, Process Sciences Downstream,
Bristol-Myers Squibb
Tom Isett, Vice President, BD Biosciences – Advanced Bioprocessing
James W. Brooks, Ph.D., R&D Manager, BD Biosciences – Advanced Bioprocessing
Approaches to Reduce Investment and
Accelerate Process Development
8:15 High-Throughput Strategies for the Efficient Selection of
High Antibody Producing Recombinant CHO Cell Lines
This talk will focus on two complementary high-throughput selection
strategies that have been developed for generating HuMAb expressing CHO
cell lines using a universal animal component-free media: 1. BASE-HIT:
Batch Amplification and Selection - HIgh Throughput. 2. The use of semisolid media and automated picking of high producing clones, where plating
efficiency at various stages of development has been optimized.
Joel Goldstein, Ph.D., Associate Director, Process Development, Medarex
8:45 High Expressing CHO Transient System for Producing
Multi-Gram Amounts of IgGs
We have developed a simple, efficient, scalable and high yielding proprietary
CHO transient expression system capable of rapidly producing multi-gram
amounts of IgG for early drug development studies. This presentation will
summarize data from the extensive optimization of the whole process
which resulted in a system capable of expressing several hundred mg/L
and successful scale-up to 250L SUB. The CHO transient system is now
routinely used to provide gram amounts of research grade material.
Lekan Daramola, Head of Early Expression and Supply, Cell Sciences,
MedImmune Limited, United Kingdom
9:15 Using Perfusion Process to Reduce Investment and Accelerate
Process Development – Advantages and Limitations
Due its low capital investment requirement, perfusion process has been used
as an early development tool, and increasingly, the “early launch” option.
Perfusion process provides a stable cell culture environment that is suitable for
both unstable and stable products. However, some operational and logistical
challenges do exist for a commercial scale perfusion process. Early focus on
process set-up such as the proper identification of raw material “lineage” will
significantly reduce operational complexity and aid incident investigation.
Paul Wu, Ph.D., Director of Upstream Development, Global Biological
Development, Bayer HealthCare
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
10:30 Use of Site-Specific Recombination (AttSite™ Recombinase
Technology) for Cell Line Development
The AttSite® Recombinase Technology, Intrexon, Blacksburg, VA, utilizes
gene-targeting enzymes that catalyze stable and irreversible insertions,
deletions or inversions of DNA at specific locations in the host cell genome.
Using this technology, we developed CHO cell lines that contain a sitespecific recombination point at a high-expressing site within the cell genome.
We used these AttSite® -containing cell lines to replace pre-selected ‘targeting
sequences’ with genes encoding a monoclonal antibody or other therapeutic
proteins being developed by Centocor. Importantly, the exchanged genes
preferentially integrated into the transcriptionally active site or ‘hot spot’
resulting in very consistent high-levels of protein expression.
Susanne Corisdeo, MS, Research Scientist, Gene Expression, Centocor R&D
Marguerite Campbell, MS, Senior Associate Scientist, Gene Expression, Centocor R&D
Innovations in Media Development
11:00 A Systematic Approach to Develop Chemically-Defined
Cell Culture Platform Media
A systematic approach will be described to illustrate how to develop chemicallydefined media and feeding strategies across multiple model cell lines. The
presentation will focus on key features of the fed-batch media development to
meet different development goals for harmonized and enhanced processes. A
few examples will be presented to demonstrate that significant titer improvement
(>8g/L) can be achieved by applying this systematic media development approach.
Feng Li, Ph.D., Senior Engineer, Process Research and Development,
Genentech, Inc.
11
8:15 Use of High Throughput Screening Approaches to
Evaluate Potential Improvements to Wyeth's Monoclonal
Antibody Platform Purification Process
The use of HTS methods has enabled rapid assessment of potential
improvement in selectivity and capacity for impurities (HMW) on the
anion exchange AEX step of the two-column monoclonal antibody platform
process. This presentation will focus on the approaches used to evaluate
AEX resins with respect to both product and impurity binding.
Mary B. Switzer, Ph.D., Senior Research Scientist II, Drug Substance
Development, Wyeth BioPharma
8:45 Maximizing Throughput – Technology vs. Facility:
Utilization of Best Process Technology versus Facility
Capacity and Strategies for Maximizing Kg Out the Door,
Minimizing $/Dose, While Keeping Company Harmony
Abstract not available at press date.
Please visit www.IBCLifeSciences.com/BPI for updates.
Joost Quaadgras, M.S., Research Fellow, Global Biologics, Pfizer Inc
9:15 Process Portability to Fit a Diverse Manufacturing Network
Development scientists and engineers are not only challenged to deliver
the pipeline with titers >5 g/L, but are also faced with enabling the best fit
within a diverse network of manufacturing facilities. This talk will discuss
development strategies to make purification processes more portable. In
addition, it will describe manufacturing/process bottlenecks for a “proof of
concept” purification, bringing to light facility capabilities and constraints.
Jean Bender, Ph.D., Senior Engineer, Genentech, Inc.
9:45 Networking Refreshment Break in
E: Adopting New Technology – Take II
With high therapeutic margins and an excess of
capacity, implementation of new manufacturing
technologies can be difficult to justify. This session
discusses the steps that companies take to justify, and
then implement a new process or manufacturing
approach. Also discussed will be the role of the supplier
in supporting the process for process development.
For manufacturing professionals considering the use
of a novel approach, or a vendor introducing a new
technology, this session will provide insight on how to
make the process run more smoothly.
• How are new technologies justified? What are
the drivers of change?
• The role of cost modeling
• The role of the vendor and the information/
support that they provide
• The issues/challenges with implementation and
how they were overcome
Moderator:
Peter Latham, President, BioPharm Services US
Panelists:
Üwe Gottschalk, Ph.D., Vice President,
Purification Technology, Sartorius Stedim
Biotech, Germany
Dr. Günter Jagschies, Senior Director R&D,
Strategic Customer Relations, GE Healthcare Life Sciences, Sweden
Timothy Matthews, Senior Engineer, Group
Leader, Process Development Engineering,
Genentech, Inc.
Tom Ransohoff, Senior Consultant, BioProcess
Technology Consultants, Inc.
Jayanth Sridhar, Ph.D., Associate Director,
Cell Culture Manufacturing Sciences,
BioMarin Pharmaceutical Inc.
10:30 F: Flexible, Small Scale Manufacturing
Exhibit and Poster Hall
Advances in Process Monitoring and Control
10:30 Impacts and benefits of Process Analytical Technology
(PAT) in Industrial Downstream Processing
Process Analytical Technology (PAT) is intended to support innovation
and efficiency in pharmaceutical development, manufacturing and
quality assurance. Through this initiative the FDA wants to encourage the
effective use of the most current pharmaceutical sciences, knowledge and
engineering principles, which can improve efficiencies of manufacturing
and regulatory processes. Case studies of 3 different technologies will be
shown with Process Analytical Technologies which were developed, scaledup and implemented at the industrial scale.
Margit Holzer, Ph.D., Vice President, Technologies, Novasep Process, France
11:00 Practical Aspects of On-Demand Access to Critical 8:00
CASE
STUDY Process Data from Paper Records for Monitoring
and Control of a Biopharmaceutical Manufacturing Process
Review methods used and benefits gained when manufacturers have ondemand access to data stored in paper records combined with production
data from disparate sources in one integrated, validatable environment.
Presenters will outline requirements for capturing paper records and
accessing other data, as well as organizational considerations, such as
collaboration required with internal support groups. Examples will show how
Merck Serono leveraged manufacturing process data to automate trending
and reviews of Critical Process Parameters and to enable investigations of
cause-and-effect relationships when needed. Results included reduced costs
and risks from less expenditure of staff time and increased data reliability,
with the expectation of increased ease of avoiding unacceptable process
variability and implementing process improvements when needed.
Monika Jungen, Process Engineer, Production Compliance Manager,
Merck Serono International S.A., Switzerland
Justin Neway, Ph.D., Executive Vice President and Chief Science Officer,
Aegis Analytical Corp.
Facility Scenarios
Shrinking capital budget, potential price controls
and the enduring uncertainty of clinical success
are driving companies to more flexible capacity
options. This discussion session looks at the
variety of ways to achieve flexibility in process
development in manufacturing, ranging from
disposables implementation, to modular facilities
to multi-expression design. Additionally, we will
discuss the benefits, weaknesses, and challenges of
implementing greater flexibility into your capacity.
• Disposables implementation – how much
flexibility do they really provide?
• Modular facility design – what does this really
mean and how does it add flexibility?
• What are the challenges, regulatory and
operational, that must be overcome to make
your facility multi-expression capable?
• What are the potential benefits/tradeoffs of
flexibility?
• How much flexibility do you really need?
Moderator:
Tom Ransohoff, Senior Consultant, BioProcess
Technology Consultants, Inc.
Panelists:
Parrish Galliher, Founder & Chief Technology
Officer, Vaccine Manufacturing, Xcellerex, Inc.
Dr. Günter Jagschies, Senior Director R&D,
Strategic Customer Relations, GE Healthcare Life
Sciences, Sweden
Joseph K. McLaughlin, Associate Research Fellow,
Pfizer Inc.
James M. Robinson, Vice President Technical and
Quality Operations, Novavax, Inc.
Christina Scully, Director of Manufacturing,
Bristol-Myers Squibb
To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Thursday, October 15, 2009 • Main Conference
Cell Culture & Upstream Processing
Recovery & Purification
11:30 Metabolism-Targeted Media Optimization: A Rational Approach to CHO Media Development
Metabolism-targeted media optimization involves balancing of nutrients involved in primary CHO energy metabolism.
Interactions of key amino acids, monosaccharides, glycolytic intermediates and vitamins to optimize cell growth and/or
productivity were evaluated. Numerous experiments evaluating media components were performed using shake flasks and
a novel high-throughput cell culture system. Results across several CHO cell lines indicated significant increase in product
titer when balancing ratios of media components involved in primary CHO energy metabolism.
Christina T. Petraglia, Senior Research Associate, Late Stage Cell Culture, Process Research & Development, Genentech, Inc.
11:30 Implementation of New Technology to Remove the Log Jam of Process-Related
Impurity Testing
With an ever-increasing portfolio to support, it can be difficult for analytical groups to supply test results
in a timely fashion to facilitate critical process decisions. This talk will discuss the implementation of new
technology to increase the throughput of process related impurity testing.
Eric Bishop, Scientist I, Analytical Biochemistry, MedImmune
12:00 Concurrent Technology Workshops
Accelerating Cell Line and Cell Culture Development
Workflows: Maximizing Success by
Integration of Select Automation Platforms
Robust Quality Systems
for Cell Culture Media Product Design and
Risk Management
Costs and Savings Options in Building and Operating a
Biopharmaceutical Manufacturing Facility
By utilizing a combination of automation technologies
This case study will use public information about
Building quality into product starts at the very
and statistical DOE approaches we have streamlined and
an existing facility and model its construction
nascent stages of product concept and design. The
improved both cell line development and cell culture medium
costs, present the capital breakdown for different
application of quality systems such as supplier
development workflows. Flow cytometry, ClonePixFL
components, and identify the key savings
quality management and enterprise risk management
robotics, label-free biosensor technologies and liquid handling
opportunities together with the market context that
systems are essential to ensuring consistent product
have been integrated into our workflows for real time
will lead to a change of manufacturing strategies.
performance and supply. With new regulatory
measurement of cell proliferation and protein production. We
Based on the model, a COGS breakdown will be
challenges, manufacturers of cell culture media are
will discuss how these combined technologies have improved
presented and both fixed and variable costs will be
leaning towards effective Quality Systems as the
the success rate in developing robust cell culture platforms for
discussed. Participants will receive a comprehensive
nucleus of product proposition and development.
therapeutic protein production.
overview of economical aspects of bulk drug
This focus, in turn, materializes into reducing the
substance manufacturing.
regulatory risks, cost of quality control testing
Peggy Lio, Senior Process Sciences Fellow, PD-Direct
and lead time into progression of product from
Bioprocess Services, Life Technologies
Dr. Günter Jagschies, Senior Director R&D,
development to commercialization.
Strategic Customer Relations, GE Healthcare Life
Sciences, Sweden
Asiya Imam, Ph.D., CQA, Senior Manager,
Quality Systems, BD Biosciences - Advanced
Bioprocessing
12:30 Networking Luncheon in Exhibit and Poster Hall with Roundtable Discussions
Cell Culture &
Upstream Processing
Recovery & Purification
Plenary Session: Integrating Upstream &
Downstream Processing
1:45 Chairperson’s Remarks
Paul Wu, Ph.D., Director, Upstream Development, Global Biological Development,
Bayer HealthCare
2:00 Integrating Upstream and Downstream Bioprocess Development:
What Can or Should Cell Culture Do?
As the effort to obtain higher titers in cell culture intensifies to 10 g/L and above, bioprocesses
contend with challenges of ensuring consistent cell culture outputs, as well as challenges
downstream in purifying such significant masses of protein. Upstream process conditions
can have significant impact on downstream concerns such as host cell impurities, as well as
on product quality attributes. A unified definition of design space will help identify crucial
links between upstream and downstream processes, and drive better overall bioprocess design
in delivering antibodies at industrial scale. Important to providing substantial benefit to the
industry will be the integration of upstream and downstream operations in approach, equipment,
and operational efficiency in delivering final product of consistent quantity and quality.
Srikanth Chary, Ph.D., Senior Engineer, Cell Culture Process R&D, Genentech, Inc.
2:30 A View of Integration of Upstream and Downstream
Manufacturing efficiency calls for seamless interfaces between unit operations. The
interface between upstream and downstream calls for careful consideration since different
teams often drive the development and implementation of each side. The development of
higher titers for new products and existing products puts a strain on this interface. The
challenges that result from integrating upstream and downstream process development
will be described from a holistic process perspective.
Jonathan Coffman, Ph.D., Principal Engineer II, Drug Substance Development,
Wyeth Biopharma Site Tour to Biogen Idec • 8:15 am - 11:30 am
Conference participants will have
an opportunity to tour Biogen Idec’s
manufacturing site in Research Triangle
Park. The plant is one of the largest
mammalian cell culture facilities in the
world. The tour will consist of a walk
through of the company’s 2,000 liter Small Scale facility as well as its
20,000 liter Large Scale facility and central warehouse and dispensary
areas. Closed toed shoes are required. The tour is currently full but a
waiting list is being created. Please call customer service at 800-390-4078
to add your name to the list. Additional spaces may become available.
The buses will depart convention center at 8:15 am on Thursday,
October 15 and return by 11:30 am.
Rethinking Capture Chromatography for Monoclonal Antibodies
Upstream processes with the PER.C6® cell line
have achieved 27 grams of antibody per liter in the
XD® format, and more recently over 10 grams per
liter in a fed-batch process. Such advances require
purification processes with higher capacity to be
able to use same equipment and, ideally, shorter
processing cycle-times. This talk will cover the
development of a high capacity capture step for
monoclonal antibodies. Design of experiments was
used to maximize capacity, recovery, and obtain a
purity comparable to that of Protein-A.
Blanca Lain, Ph.D., Scientist III, Downstream Process
Development, Percivia LLC
Strategy Discussion
Forums
Vaccine Manufacturing
Technology Summit
1:15 Chairperson’s Opening Remarks
James M. Robinson, Vice President Technical and Quality Operations,
Novavax, Inc.
1:15 Workshop Forum G:
1:30 Development of a New Vaccine for Plague
To meet the immediate requirement of the US Government Department
of Defense (DoD) for a stockpile of an efficacious prophylactic vaccine
for Yersinia pestis, the aetiological agent for pneumonic plague, a
concerted fast-track development program between the UK Health
Protection Agency and The US DoD Prime Contractor, DynPort
Vaccine Company, has resulted in a new vaccine manufacturing process
to support advanced clinical trials and commercial manufacture.
John Brehm, Ph.D., Scientific Program Manager, Centre for Emergency
Preparedness and Response, Health Protection Agency, United Kingdom
2:00 Economic Manufacture of Recombinant Protein and
DNA Vaccines in Microbial Systems: Technology
Driven Solutions
Vaccines (protein and DNA) manufactured using microbial expression
systems must meet stringent COG expectations in order to meet global
market requirements. Recent advances in microbial expression of
soluble proteins, cellular/extracellular localization, control mechanisms,
post-translational modification coupled with universal high cell
density fermentation cultures have driven improvements in volumetric
productivity and product quality.
Christopher Dale, Ph.D., Head of Microbial Technology, Lonza
Measurement Uncertainty:
Acknowledging, Analyzing, and Managing
Understanding and managing variability
in the measurement of inputs and outputs
is important to the definition, development
and control of all bioprocesses.
Management of measurement
uncertainty and rational incorporation of
measurement uncertainty into product
control strategies will be examined
through group discussion of several case
studies. Calibration, "guard-banding,”
P.A.T., calculation methods, and related
topics will be examined in the context
of their practical application to bioproduct
manufacturing. Attendance will be limited
to 30 to aid participation and discussion.
Facilitators:
Jeffrey C. Baker, Ph.D., Senior Director,
Manufacturing Science and Technology,
MedImmune
Bernard M. McGarvey, Ph.D.,
Engineering Advisor, Eli Lilly and Company
Thursday Highlights for Formulation Strategies for Protein Therapeutics
High Throughput Formulation Development: Concepts, Advantages and Limitations
Merck KGaA presents a case study of a high-throughput formulation (HTF) platform that integrates sample preparation,
sample analysis and data evaluation
The Effect of Freezing and Drying on Protein Stability
Increase your understanding of cold denaturation that may occur when proteins are stored at sub-zero temperatures and
learn how sucrose levels impact lyophilized products. Speakers from Genentech and Genzyme
Optimizing Analytical Methods for Formulation Development
Learn exciting new analytical approaches that help accelerate formulation development and improve product quality.
Included are methods to identify critical process parameters for formulations, development using very small sample amounts,
orthogonal tools for throughout the development lifecycle and a DLS assay for understanding reversible self-association.
Speakers from Human Genome Sciences, Genzyme, MedImmune, Diosynth Biotechnology and Novo Nordisk
BPI delegates may attend the sessions of Formulation Strategies at no additional charge. To view complete program
details and abstracts, please visit the conference website: www.IBCLifeSciences.com/Formulation
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
12
Thursday, October 15, 2009 • Main Conference
Cell Culture & Upstream Processing
Recovery & Purification
Vaccine Manufacturing Technology Summit
2:30 Scale-up of an Intensified rAd35 Vaccine Production Process in
3:00 Networking Refreshment Break in Exhibit and Poster Hall
Disposable Bioreactors
Final opportunity to consult with suppliers and view new data in posters.
3:45 Upstream – Downstream: Elucidation of the Cause and In order be able to produce an affordable PER.C6®based rAd35 tuberculosis vaccine for
global demand, a process intensification development program was started at Crucell. In
order to fit the manufacturing process in our current facilities, the focus of this program is
intensification of volumetric productivities and implementation of disposable technologies.
This presentation will highlight our strategy and progress.
Ciska Dalm, Ph.D., Scientist, Upstream Process Development, Crucell Holland BV,
The Netherlands
CASE
STUDY
Mechanism of Aggregation of an IgG4 Antibody
Upstream process modifications can have a significant impact on quality attributes of proteins, with consequences not fully realized
until the drug substance is placed on stability. This case study describes how modification of cell culture conditions resulted in an
increase in the oxidation of an IgG4 antibody, leading to a higher rate of soluble aggregate formation in the purified protein.
Thomas C. Furman, Research Advisor, Bioprocess Purification Development, Eli Lilly and Company
Keynote Presentation
3:00 Networking Refreshment Break in Exhibit and Poster Hall
Final opportunity to consult with suppliers and view new data in posters.
3:45 GMP Vaccine Manufacturing in Single Use Stirred 4:15 Integrating New Technologies in Upstream and Downstream Processing –
When to Innovate? What are the Barriers? What are the Challenges?
Tank Bioreactors: Case Studies with Microcarriers and Various Vaccine Types
Genzyme has developed and implemented several large scale continuous processes for manufacturing of
therapeutic proteins and synthetic molecules. While the corresponding technology platforms have evolved
independently, there are multiple essential concepts and approaches that are compatible. We will review these
similarities, and will explore the synergistic opportunities to bridge knowledge in these two areas, including
process design concepts, new technologies, and logistics.
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corp.
The paper will present a case study of a viral vaccine for a tropical disease produced
in single use stirred tank bioreactors by attachment dependent cells on microcarriers
in serum free medium, as well as a variety of other vaccine types. A discussion of the
challenges for bioreactor scale up will be included. The possibility of more universal
“generic” vaccine plants will also be discussed.
Parrish M. Galliher, Founder & Chief Technology Officer, Xcellerex, Inc.
4:15 Manufacture of Live Attenuated Biodefense Vaccines Plenary Panel Discussion
Using Disposable Technology in a Virtual Environment
5:00 What More Can Be Done to Increase the Integration of Upstream and Downstream Processing
• Can the Two Areas be Combined into one Continuous Process?
• Can (how will) Downstream Handle 10+ g/L Going Forward?
• Harmonization of Equipment and Operational Practices
• Benefits/Disadvantages of Higher Expression Levels on Purity CASE
STUDY
To address the complex and urgent needs of biodefense vaccine production, a portfolio
of manufacturing approaches must be used. For live attenuated viral vaccines grown
in stationary cell culture, we have found that disposable technology yields excellent
results in terms of speed, flexibility, and cost. Another advantage is that this technology
is simple and easily transferrable between manufacturers, making it ideal for use in a
virtual environment in which biodefense vaccine development is done using multiple
specialty subcontractors. This presentation will describe the technology and give
examples of two vaccines in which this approach was utilized.
Robert V. House, Ph.D., President, DynPort Vaccine Company LLC
• Integrated QbD Approach
• Impact of Cell Harvest Step on Product Quality
• How Media Development Affects Analytics
• Filtration Step – Clarifying Challenges Between Upstream
and Downstream Processing
Moderator:
Tim Charlebois, Ph.D., Senior Director, Drug Substance Development, Wyeth Biopharma
Panelists:
Srikanth Chary, Ph.D., Senior Engineer, Cell Culture Process R&D, Genentech, Inc.
Jonathan Coffman, Ph.D., Principal Engineer II, Drug Substance Development, Wyeth Biopharma
Thomas C. Furman, Research Advisor, Bioprocess Purification Development, Eli Lilly and Company
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corp.
CASE
STUDY
5:00 Audience Interactive Panel Discussion: Critical Vaccine Manufacturing Challenges
Moderator: James M. Robinson, Vice President Technical and Quality Operations, Novavax, Inc.
Panelists: All Vaccine Summit presenters
5:30 Close of Shared Plenary Session
5:30 Close of Vaccine Summit
Friday, October 16, 2009 • Main Conference
7:00 Registration and Coffee
7:15 Technology Workshop Presentation Opportunity Available. Please contact Jennifer McElligott at 508-614-1672 or jmcelligott@ibcusa.com or Kristen Schott at 508-614-1239 or kschott@ibcusa.com
Cell Culture & Upstream Processing
8:00 Chairperson’s Opening Remarks
8:00 Chairperson’s Opening Remarks
Dennis Kraichely, Ph.D., Principal Research Scientist, Expression
Technologies, Centocor Inc.
David W. Kahn, Ph.D., Director, Late-Stage Purification Development,
Human Genome Sciences, Inc.
Technologies to Analyze, Measure and
Control Processes
8:15 Revitalizing a Legacy Cell Culture Process in Fitting it to a New Facility: A Case Study
CASE
STUDY
This presentation will discuss optimization performed with legacy fed-batch
processes alongside their transfer for manufacture in new facilities. A case study
on optimization of inoculum expansion, seed bioreactors, and production
bioreactor will be discussed. Improvements in inoculum expansion included
replacement of spinner flasks with shake flasks and replacement of multiple flasks
by single disposable bioreactors. Seed bioreactor optimization included provision
of partial transfers. Production bioreactor changes lead to feeding strategies based
on metabolite measurement and pH control via blood gas analyzer measurements.
All of these changes helped improve consistency or scheduling of batches and
improved the likelihood of batches being harvested successfully.
Douglas Osborne, Scientist I, Cell Culture Development, Biogen Idec
8:45 Real Time Analysis to Aid Media and Process Development CASE
STUDY
BaychroMAT is a platform that automates analyzers. Additional automation
components enable high operational availability. This system includes an
innovative sterile Online Port, an automated sample transport, an integrated
sample preparation module, online analyzers and communication interfaces
to process automation systems. Real-time data will be presented and benefits
for media optimization and process development will be demonstrated.
Stefan Steigmiller, Ph.D., Senior Project Manager, PAT, Bayer Technology Services GmbH, Germany
13
Strategy Discussion Forums
Recovery & Purification
Applying Analytical Methods in
Downstream Processing
8:15 Next Generation Membrane Adsorbers – Meeting Process
Development Challenges
While commercially available anion-exchange (AEX) membrane adsorbers
provide host cell protein clearance (HCP) comparable to columns at lower
conductivities than that used for columns, the larger dilution of feedstreams
can present plant fit challenges. To facilitate wider adoptions of AEX membrane
chromatography at commercial scale, there certainly is a need for high salt
tolerant membrane adsorbers. In this study, membrane adsorber properties
such as ligand density, pore size and membrane chemistry were evaluated to
explore their impact on HCP clearance over a wide range of salt concentrations
using a manufacturing scale therapeutic monoclonal antibody feedstream.
Amit Mehta, Ph.D., Engineer II, Late Stage Purification, Genentech, Inc.
8:45 High Throughput Analytical Methods for Downstream Bioprocessing Development
CASE
STUDY
To facilitate the acceleration of downstream bioprocess development, we have
developed several novel analytical approaches, including high throughput
methods for host cell protein, leached Protein A, product size and charge
heterogeneity. We further developed a novel interfacing system for on-line
analysis of column recovery operations. With these approaches, critical analytical
end points can be generated to enable accurate and timely process decisions.
Judy H. Chou, Ph.D., Group Leader, Oceanside Process Research &
Development, Genentech, Inc.
8:15
H: Process Validation for the 21st Century
In November last year the FDA issued a new Draft
Guidance on Process Validation: General Principles
and Practices. It is intended to reflect some of the
goals of the FDA’s Initiative on Pharmaceutical GMPs
for the 21st Century. Major changes in the approach
to process validation are proposed and the response
from industry has been spirited.
Key topics for discussion in the session will be:
• Do we need a clearer definition of key terms and
concepts in the Guidance?
• Can the new approach be better aligned with ICH
Q7, 8, 9 and 10?
• How many process qualification batches will suffice?
• How does one determine whether sufficient data
have been collected for statistical analysis of the
qualification runs?
• What will be the effect of the “Continued Process
Verification” requirement on production costs?
Moderator:
Alex D. Kanarek, Ph.D., Senior Consultant,
BioProcess Technology Consultants, Inc.
Panelists:
Ali M. Afnán, Ph.D., Senior Staff Fellow, OPS,
CDER, US FDA
Joydeep Ganguly, Associate Director, Manufacturing
Sciences, Biogen Idec
Victor A. Vinci, Ph.D., Director, Bioprocess
Operations, Eli Lilly and Company
To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Friday, October 16, 2009 • Main Conference (continued)
Cell Culture & Upstream Processing
Strategy Discussion Forums
Recovery & Purification
9:15 Advanced Data Analysis Benefits within Small Scale and
9:15 Analytical Tools in Support of Optimization of the
Production Scale Cell Culture Processes
Manufacturing Process of Immunoconjugates
This presentation will provide an overview of advanced analysis techniques
and their uses within cell culture process monitoring and understanding. The
presentation will focus on the improved monitoring capability of production
scale processes, small scale analysis, and process predictive modeling.
Greg Stromberg, MBA, Senior Associate Scientist, Biogen Idec
Immunoconjugates are antibodies armed with cytotoxic agents. During
manufacturing, the chemical reactions used for attaching cytotoxic agents to
antibodies create by-products that need to be eliminated and, under certain
conditions, they can yield undesired species. We developed analytical tools
capable of monitoring the quality of the products obtained during process
optimization, assuring the development of robust manufacturing processes.
Alex Lazar, Ph.D., Senior Scientist, Analytical and Pharmaceutical Sciences,
ImmunoGen, Inc.
9:45 Networking Refreshment Break
Application of Genomic, Proteomic and
Metabolomic Technologies
9:45 Networking Refreshment Break
10:15 I: Navigating the Pathway to Regulatory
9:45 Networking Refreshment Break
10:15 Global Biochemical Profiling for Upstream Bioprocess
Alternatives to Traditional Column Purification
Optimization: Challenges and Opportunities
Global metabolic profiling is an unbiased approach to understand
the metabolic state of cells and their surrounding environment. This
presentation will discuss specific applications of this technology as a tool
to provide traction in upstream process development activities. Attendees
will learn how this technology was used to determine the metabolic changes
induced by variations in process conditions.
Susan Casnocha, Ph.D., Associate Research Fellow, Global Biologics,
Pfizer Inc.
10:15 Polyethylene Glycol Precipitation of Monoclonal
Antibodies and the Impact on Column Chromatography
This talk will discuss PEG precipitation as an alternative to chromatography
in an antibody purification process. The effects of PEG concentration,
pH and conductivity on precipitation performance were evaluated. PEG
precipitation removed impurities including host cell proteins, aggregates,
leached Protein A and DNA. We will discuss the impacts of implementing
PEG precipitation in a two chromatography step purification process.
Glen Giese, Research Associate, Early Stage Purification, BioProcess
Development, Genentech, Inc.
10:45 Metabolic Flux Analysis in Mammalian Cell Culture
Metabolic flux analysis is an elegant approach to quantitatively characterize cell
metabolism and substantially enhance our understanding of cell physiological
state both in process development and manufacturing-scale bioreactors.
Data from both the metabolite balancing and isotope tracer methods for flux
analysis will be presented and application of metabolic flux analysis to process
development and manufacturing-support scenarios will be demonstrated.
Chetan T. Goudar, Ph.D., P.E., Head, Cell Culture Development, Global
Biological Development, Bayer HealthCare
10:45 Application of a Cationic Membrane Adsorber for the Purification of Recombinant Proteins
Ion exchange membrane adsorbers are gaining popularity due to the
benefits they present compared to traditional chromatography resins. In
this study, a membrane adsorber was evaluated as an alternative to column
chromatography for the purification of a recombinant protein. The membrane
adsorber showed improved protein recovery with increased clearance of host
cell protein impurities. The study demonstrates the feasibility of replacing a
chromatography column with a membrane adsorber.
Rao Koduri, Ph.D., Senior Scientist, Purification Development Group,
Genzyme Corporation
11:15 RNAi Mediated Gene Silencing of Recombinant IgG Leads
to Gene Expression Profile Changes in CHO Cells
Small interfering RNAs (siRNAs) against a recombinant human IgG were
transfected into a CHO cell line stably expressing the IgG. Transcriptional
profiling of the cell cultures, comparing IgG siRNA-treated cells to cells
treated with a non-targeting siRNA, revealed 151 genes that were differentially
expressed. Many of these genes have functions in protein secretion and
folding, immunoglobulin production and protein glycosylation.
Trissa Borgschulte, Ph.D., Senior R&D Scientist, Cell Sciences and
Development, SAFC Biosciences, Sigma-Aldrich
CASE
STUDY
Approval from Phase I to PAI
Experience based guidance will be offered by
the panelists, beginning with application of an
Incremental Approach to cGMPs as products
advance from preclinicals through all phases of
clinical development, validation & conformance.
Step by step analysis of PAI preparedness,
including examples of inspection readiness
plans, such as moving from a single product
to multi product facility and bringing a new
manufacturing site online and working with
CMOs, will be presented.
• Side by Side Comparison of cGMP applied to
clinical vs. commercial production
• PAI Readiness with a CMO vs. in-house
Manufacturing
• Interpreting FDA Guidance on "Process
Validation and General Principles"
Moderator:
Kathryn D. Simon, Ph.D., Director,
Upstream Production & Development, Diosynth Biotechnology
Panelists:
Michelle Jones, Director, Regulatory Compliance,
Human Genome Sciences, Inc.
Ned Wyman, Senior Manager, Validation,
Medimmune, Inc.
Additional panelists to be announced
11:15 Evaluation of a New Synthetic Depth Filter for
Monoclonal Antibody Purification
This presentation will provide an overview and data from extensive
evaluation of a new completely synthetic depth filter (still under
development) for antibody purification applications which could have a
profound effect on the standard monoclonal antibody platform.
Judy Glynn, M.S., Senior Principal Scientist, Pfizer Inc
11:45 Concurrent Technology Workshops
Strategies for Single Use in Tangential Flow Filtration Applications
Single use technology has become well established in the biopharmaceutical industry. The
Novasep offers the first pre-sanitized, purpose built, single-use tangential flow filtration cassette for biopharmaceutical applications. Each SIUS™ cassette arrives pre-sanitized, ready to be equilibrated with
buffer and used for processing. This presentation will identify the key points for utilizing a single use strategy for
tangential flow filtration application.
Michael LaBreck, Sales Manager, Novasep, Inc.
Single-Use Technology from New Brunswick Scientific
As single-use technology continues to increase in acceptance and demand
as an alternative to traditional steel and glass bioprocess vessels, New Brunswick is proud to offer its own
unique single-use bioreactor system. Designed for ease of use and true scalability, the CelliGen® 315s with its
optional packed bed perfusion configuration is a system that can provide the results advocates of single-use
technology have been demanding.
Richard Mirro, Product Manager, New Brunswick Scientific
12:15 Luncheon Presentation
12:15Rethinking Tangential Flow Filtration: Design, Operation and Processes using Single Pass Systems Single Pass TFF (SPTFF) is a new form of tangential-flow filtration (TFF) delivering high-conversion separations without a recirculation loop, thereby providing the
performance of TFF with the simplicity of direct-flow filtration. In addition to offering multiple economic benefits, SPTFF delivers important operational benefits and
new capabilities such as increased yield, lower hold-up volume, very high concentration factors, and low exposure time. SPTFF is easily integrated with other downstream
processes, such as chromatography and virus removal.
Steven Pearl, Vice President of Biopharmaceutical R&D, Pall Life Sciences
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
14
Cell Culture & Upstream Processing
Recovery & Purification
1:30 Chairperson’s Opening Remarks
1:30 Chairperson’s Opening Remarks
Kelly Wiltberger, Senior Manager, Biopharm Development, Biogen Idec
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
New Approaches and Technologies for
Downstream Processing
Process Quality and Characterization
1:45 Effects of Cell Culture Conditions on Antibody N-linked Glycosylation – CASE
STUDY
What Affects High Mannose 5 Glycoform
The glycosylation of recombinant monoclonal antibodies frequently has impact on in vivo biological
activity. Cell culture conditions such as cell line characteristics, culture media, and process parameters can
impact glycoform distribution during production. The results to be presented improve our understanding
of how to achieve a consistent product quality profile with respect to glycosylation by controlling
important cell culture conditions.
Efren Pacis, Senior Research Associate, Process Research and Development, Genentech Inc.
2:15 Identification of Critical Quality Attributes during Cell Culture and Upstream Processing
Identification of critical quality attributes is essential for the implementation of suitable testing plans and process
controls for biopharmaceutical products. This presentation will describe a rationale for determining critical
quality attributes during product development. The focus will be on cell culture and upstream processing CQA
identification and determination of the likelihood of occurrence and impact on efficacy or safety.
Patricia Cash, Ph.D., Senior Director, Analytical Biochemistry, MedImmune
2:45 Gain Process Understanding Using Design of Experiments (DOE)
Abstract not available at press date.
Please visit www.IBCLifeSciences.com/BPI for updates.
Jim Reynolds, M.S., Scientific Fellow, Center for Mathematical Sciences, Merck & Co., Inc.
CASE
STUDY
CASE
STUDY
2:15 Innovative, Non-Traditional Approach to Purification & Scale Up of a Fusion Protein: A Case Study of an Enzyme-Fc-D10 Fusion Protein
CASE
STUDY
2:45 Integration of New Technologies and Approaches to Accommodate CASE
STUDY
Straight Through Processing (STP) for DSP is a proposed concept to automate process buffer preparation
and to combine three purification steps, a DSP1 Chromatography step, a DSP2 Chromatography step,
and a Virus Removal Filtration (VF) step into a streamlined single unit of operation. This would shorten
the overall operation time, improve facility utilization, and eliminate certain intermediate hold and inprocessing testing requirements for MAB manufacturing.
Bin Lin, Ph.D., Senior Research Scientist, Purification Science, Centocor R&D, Inc.
Tech transfer & scale up is an essential part of the development of every biopharmaceutical product as it
moves from discovery to clinical and commercial production. EA2 is a novel, engineered fusion molecule
composed of three domains: an enzyme, Fc portion of IgG, and an anionic peptide. The presentation will
cover evaluation of several different purification modalities and selection of a final process for production
of high quality clinical material. We will describe our ongoing effort to scale up this process to kilogram
scale as well as touch briefly on the softer side – team chemistry, forward planning, open communications,
flexibility and professional trust that is an integral part of any successful tech transfer and scale up project.
Jayant Aphale, Ph.D., Vice President, CMC Manufacturing & Process Sciences, Enobia Pharma
Large-Scale Multi-Product Clinical Manufacturing
3:15 Networking Refreshment Break
Scale-Down Models and Scaling Up Case Studies – Lessons Learned
3:30 Agitation, Aeration, and their Effects on Cell Culture Performance in Stirred-Tank Bioreactors
CASE
STUDY
A unified model of agitation and aeration in stirred-tank bioreactors was developed in response to poorerthan-expected performance observed upon scale-up of a mammalian cell culture process. This unified
model has led to significant benefits including (1) more consistent performance across scales; (2) improved
cell culture performance (e.g. - higher productivities); (3) improved product quality; and (4) “cleaner”
conditioned media resulting in improved downstream processes.
Jose M. Gomes, Senior Research Scientist, Manager, Bioreactor Process Development, Wyeth Biopharma
4:00 Impact of Specific Power of Agitation on Host Cell Impurity Generation
by a Mammalian Cell Culture in a Perfusion Bioreactor System
CASE
STUDY
Perfusion bioreactors of different volume expressed different levels of host cell impurities. Many millions
of dollars were potentially at risk due to the generation of out of specification material. It was discovered
that specific power of agitation was the root cause for the difference. This case study covers the discovery,
understanding and correction of the problem, including agitation experiments.
Scott Probst, Ph.D., Principal Technology Specialist, Biopharma Technology Solutions,
Bayer Technology Services
4:30 Cell Culture Process Scale Up, Technology Transfer and Assessment of Process Comparability Using Multivariate Analysis: A Case Study
CASE
STUDY
A CHO antibody production process was developed and transferred from a cell culture process
development laboratory to a cGMP pilot plant facility for clinical manufacturing. Eight 1200L culture
production batches were successfully executsed. Multivariate Data Analysis was used to assess
comparability of the CHO cell culture process across scales and among batches. Process scale-up and batch
comparability were demonstrated with respect to product quality and titer.
Hang Yuan, Ph.D., Senior Scientist, Mammalian BioProcess Research & Development, Global Research &
Development, Pfizer Inc.
5:00 Close of BPI 2009
1:45 Straight Through Processing (STP) of Monoclonal Antibody Purification Creating the flexibility necessary to operate a large-scale multi-product facility that can accommodate
purifying 8-20kg of antibody mass per week, using traditional stainless steel dedicated equipment, has
required the integration of new technologies and approaches. The inherent design and capacity limitations
of the facility have been addressed by implementing a flex-bag bulk fill system, sterile connectors,
disposable filters, process optimization, and operating scenario evaluations.
Stuart Green, Associate Director, Purification, BB50 Commercial Manufacturing, ImClone Systems, a
wholly-owned subsidiary of Eli Lilly and Company
3:15 Networking Refreshment Break
New Therapeutic Modalities
3:30 The Role of Biopharmaceutical Process Development in Regenerative Medicine
Regenerative Medicine is a field based on therapeutic strategies that help patients to permanently
regenerate tissue structure and organ function as opposed to implanting medical devices or temporarily
treating symptoms with drugs. Technologies include stem cell therapies, growth factors, resorbable
tissue scaffolds and controlled release of biologically active agents. This presentation will focus on how
traditional biopharmaceutical industry skills in cell culture and purification intersect with the needs of
regenerative medicine.
Peter W. Wojciechowski, Ph.D., Director, Process Development,
Advanced Technologies and Regenerative Medicine LLC
4:00 Peptide-Protein Conjugates
Peptide-monoclonal antibody conjugates are effective vehicles to reduce toxicity and to enable site-specific
drug delivery. In this presentation, we will discuss the strategies used to meet the challenges to generate the
conjugates, and to develop analytical methods, including functional bioassays.
Wei Liao, M.D., Project Team Leader, Biotherapeutics Center of Emphasis, Pfizer Inc
4:30 NPro Autoprotease Fusion Technology (NAFT) – The Key to Cost Effective Manufacture of Peptides?
5:00 Close of BPI 2009
venues for obtaining the most current information
“ BPI Conferences areonessential
developments within Biopharma..
– Christopher Dale, Ph.D., Head of Microbial Technology, Lonza
15
CASE
STUDY
A new system for expression of fusion proteins in E. coli with autocatalytic cleaving properties (NAFT)
as a platform technology for cost effective manufacture of peptides will be presented. High fermentation
yields (up to 10 g/L) for NPro fusion proteins were reached. Process upscaling to 13,000 L and advantages
compared to classical fusion protein approaches are discussed in a case study.
Friedrich Nachtmann, Ph. D., Head, Biotech Cooperations, Sandoz Biopharmaceuticals, Austria
“
Friday, October 16, 2009 • Main Conference (continued)
To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
IBC Professional Training Academy
Two Day Training Courses from the IBC Professional Training Academy • Tuesday, October 13, 2009 - Wednesday, October 14, 2009
Introduction to
Biopharmaceutical Manufacturing
Technology Transfer in
Biopharmaceutical Development
Scalable Transient Protein
Production in Mammalian Cells
Course Description
Course Description
Course Description
This course introduces the fundamental processes and operations in the
manufacture of biopharmaceuticals. Beginning with expression systems and
moving through fermentation, cell culture, recovery, purification, formulation
and filling, we will discuss the process steps involved in producing biological
products. Also, you will be introduced to the basic concepts of process design
and analytical methods for characterization of biological products. The course
will conclude with a description of the role of quality and the regulatory
environment under which biologicals are produced, including validation.
Though the manufacture of biopharmaceuticals is complicated and difficult,
this course will provide a perspective on the many operations that make up a
manufacturing process and help you understand how they work together to
produce safe and effective products.
Increased clinical and commercial outsourcing of biopharmaceutical
manufacturing has led to greater emphasis on technology transfers.
However, companies are reluctant to spend the upfront time, money,
and planning that is needed for tech transfer other than “to go and do
it”. The result is delayed launches, wasted time and an impact to the
bottom line. This course explores the technical aspects of process and
analytical transfers that are needed as an organization embarks upon a
manufacturing process transfer from one location to another, whether it
is an internal transfer or an external transfer. Upstream and downstream
process transfers will be considered, along with the regulatory
compliance requirements for cGMP manufacturing. Issues associated
with international technology transfers will be also be discussed. The
importance of strong project management and the creation of crossfunctional teams are emphasized.
This course introduces the fundamental concepts needed to establish small
to large-scale transient protein production systems using mammalian
cells. The class examines in detail the four essential elements of any
mammalian transient production system: cell lines, expression vectors,
transient transfection and cell culture. The course helps participants
understand differences and tradeoffs in producing recombinant proteins
in HEK293, CHO, or other mammalian cells. Expression vector design
and optimization, and critical cell culture techniques will be reviewed.
Specific focus is placed on best practiecs and techniques for production
of antibodies. The most commonly used transfection reagents and
transfection methods are examined. Attendees gain an understanding of
the equipment needed to establish a transient production facility, methods
to monitor culture conditions and how to assess transfection efficiency.
Who Should Attend
• Individuals who need a working knowledge of basic biotechnology
design principles
• Managers responsible for process design, facility design, equipment/system
design/selection or operation of a biopharmaceutical production facility
• Scientists, managers and engineers involved in biopharmaceutical project
engineering, QA/QC, facility design or facility construction
• Individuals beginning work in production operations, quality assurance,
regulatory compliance or other areas in
a biopharmaceutical facility or biopharmaceutical
development company
Who Should Attend
Who Should Attend
• Managers, scientists and associates working in process and analytical
development who are involved with the technology transferring of
biotechnology processes and analytical methods
• Manufacturing and quality professionals
• Scientists from Discovery, Product Development and Supply-Chain
Management
• Scientists needing to quickly produce milligram to gram quantities of
recombinant protein in mammalian cells
• Scientists, managers and lab directors establishing core protein
production services for drug discovery
• Bioproduction and Process Development scientists wanting to learn
about transient protein production methods
• Protein expression scientists looking to scale up production
Course Instructor
Course Instructor
Scott M. Wheelwright, Ph.D.
Course Instructor
Siddharth (Sid) J. Advant, Ph.D.
Head, Biotech Sector
Tunnell Consulting
President and Chief Executive Officer
Strategic Manufacturing Worldwide, Inc.
Henry C. Chiou, Ph.D.
Principal Scientist, Invitrogen Molecular Biology Systems
Life Technologies
Training Course Schedule
• Registration begins at 8:15 on Tuesday, October 13, 2009. Please check in at the attendee registration desk to receive your badge and materials.
• Each day the course begins at 9:00 am and concludes between 5:00 pm – 5:30 pm. Continental breakfast is served from 8:15 am – 9:00 am. There are two refreshment breaks at approximately 10:00 am and
3:00 pm. Lunch is served each day at approximately 12:00 pm. Refreshment breaks, lunches, and meeting conclusion times may vary slightly based on delegate interaction and the instructor’s discretion.
For further information, visit www.IBCLifeSciences.com./Courses
Career Development Seminar • Wednesday, October 14 • 10:00 am – 12:00 pm
We are pleased to present the BioProcess
International Conference - BioSpace
Career Fair — a regional career event
devoted to the biotechnology and
pharmaceutical industries.
Attend this seminar and take in an informative, honest, and interactive discussion with direct implications
on your own career. We've gathered an expert team of professionals from industry and academia who will
collectively share a rounded view on topics including, but not limited to: the current state of the job market,
workforce development, education's role in starting and expanding you career, job seeker etiquette, and proper
use of internet technology in a job search. We look forward to seeing you at this session! (Open to BPI conference
attendees and exhibit hall only attendees, as well as Biospace Career Fair Attendees.)
Speakers / Panelists will include:
George Kafes, Corporate Recruiter, Biogen Idec, Inc.
Ash DeVane, CPC, Principal Recruiter, Owner, CENTURY Search, Inc.
Marcelo Anderson, Assistant Director, Industrial Relations & Student Coordination, BTEC / North Carolina
State University
Kay Henry, Associate Dean & Director, Executive MBA Programs, Washington University
Rob Humphrey, CEO, VEERORANGE - Social Media Recruitment Consultancy
Wednesday, October 14
1:00 pm - 6:00 pm
BioSpace has produced over 200 Life
Science Career Fairs over the past
decade. Leveraging this experience with
IBC’s reach and the buzz surrounding
the BioProcess International Conference
& Exhibition (BPI), the BPI-BioSpace
Career Fair is certain to be an incredibly
productive day for bioscience recruiters
and candidates.
BioProcess International Conference attendees, as well as any qualified industry
professionals, including those not attending BPI, are welcome to visit the Career Fair.
Attendance is free but advance registration, separate from BPI registration, is
required. Please register at www.biospace.com/bpi2009
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
16
Meet the People Behind the Products and Get the Answers You Need
Diamond Sponsor:
BD Biosciences is a life sciences leader with more than 50 years of expertise
in cell biology products and services. The Advanced Bioprocessing strategic
platform developed products are currently being used as critical components
in the production of some of the most widely used drugs and vaccines on
the global market today. BD Biosciences - Advanced Bioprocessing (BDB-AB)
is playing a major role in biopharmaceutical drug production, enabling
customers large and small to have a tremendous impact on the future of
human healthcare. BDB-AB‘s novel portfolio of hydrolysates, cell culture
media & supplements and services is the optimal choice for your mammalian
cell culture and bacterial fermentation bioprocessing needs.
Platinum Sponsor:
Diosynth Biotechnology, a full service contract manufacturer, has a
proven track record in cGMP manufacturing of more than 80 complex
recombinant proteins for clinical and commercial use. We help our
customers by offering technical excellence, reliable execution, collaborative
project management, and demonstrated regulatory expertise. Diosynth
Biotechnology is a part of Schering-Plough Corporation.
Gold Sponsors:
Invitrogen develops life science technologies for molecular and cell
biology, bioproduction and clinical applications. We accelerate biological
understanding through technologies and services that include leading
industry names such as GIBCO, Molecular Probes, and Dynal. Our
portfolio spans the breadth of drug applications and emerging areas.
Lonza is a life sciences company and leading custom manufacturer of
biopharmaceuticals, active pharmaceutical ingredients and chemical
intermediates. We create value for customers – large and small – through
cutting-edge development services and advanced production processes
in mammalian cell culture, peptide synthesis, cell-based therapeutics,
microbial fermentation, and organic chemical synthesis. We can help.
Novozymes Biopharma is a part of Novozymes A/S, the world
leader in bioinnovation. Novozymes Biopharma is dedicated to
the biopharmaceutical industry. With over 25 years of leadership in
biomanufacturing and process development, Novozymes offers regulatorycompliant, dedicated, and proven solutions to optimize your manufacturing
process, drug formulation and drug delivery. Find out more about
Novozymes Biopharma at www.biopharma.novozymes.com
The life sciences industry is both driven and united by its need for speed
to market, product reliability and economics. Pall’s leading edge filtration,
separation and purification technologies and services play an essential and
pivotal role in this industry’s ability to achieve these goals. In the laboratory,
Pall products help to facilitate the drug discovery and development process to
get innovative drugs to the market faster. In Biopharmaceuticals, Pall filtration,
chromatography, sampling, monitoring and quality assurance products,
together with technical services in validation, assays and process optimization
are applicable to laboratory and pilot-scale development, aseptic processing,
biologicals, bioprocessing, fermentation and downstream processing.
Silver Sponsor:
Thermo Scientific HyClone Cell Culture products and BioProcessing
systems advance productivity for life-science research and protein-based
drug production. Widely known as the premier supplier of quality sera for
cell culture, HyClone classical media, serum-free and protein-free media,
process liquids and flexible, single-use BioProcess Container systems
provide technology and innovation for your research.
Applied Biosystems is now a part of Life Technologies Corporation
(NASDAQ:LIFE), a global biotechnology tools company dedicated to
improving the human condition. Life Technologies was created by the
combination of Invitrogen Corporation and Applied Biosystems Inc.
Gold Sponsor:
A provider of biopharmaceutical manufacturing technology and services
including custom manufacturing, XD® Technology for mammalian cell
lines, and licensing of the PER.C6® human cell line. Years of experience in
cGMP manufacturing services provides companies with a turn-key biologic
manufacturing solution reducing cost, risk, and time to market.
GE Healthcare provides products and services for life sciences that
include chromatography, membrane filtration, cell culture, DNA
synthesis, technical training courses and validation services spanning
laboratory to production scale.
Gyrolab GXP® enables miniaturized and automated assays. Gyrolab®
facilitates rapid optimization, wide dynamic range, and improved
sensitivity over ELISA from low-volume, complex samples; allowing
detection of impurities and host cell proteins.
Bronze Sponsors:
Session Sponsor
Strategic Discussion Forum Sponsors
Technology Workshop Sponsors
BD Biosciences – Advanced Bioprocessing
Novozymes
Tarpon Biosystems
Lonza
Applied Biosystems
BD Biosciences – Advanced Bioprocessor
BioSystem Development, LLC
Diosynth Biotechnolgoy
GE Healthcare
Invitrogen
Irvine Scientific
Lonza
New Brunswick Scientific
Novasep
PBS Biotech, Inc.
SynCo Bio Partners
Thermo Scientific
Tosoh Bioscience LLC
Technology Workshop
Luncheon Sponsors
Reception Co-Sponsor
Diosynth Biotechnology
Hospitality Suite Sponsor
Tarpon Biosystems
Exhibit Hall Presentation Sponsor
Artelis
Badge & Lanyard Sponsor
DSM Biologics, Inc.
Site Tour Sponsor
Diosynth Biotechnology
Literature Sponsor
Novozymes
TSI, Incorporated
Millipore
Pall Life Sciences
Make the Most Impact at the Best Marketing
Forum in the Bioprocessing Industry
In the five short years since its inception, this event has doubled in size to over 1,500 participants
and more than 150 exhibitors. Where else can you meet face-to-face with key decision-makers
within biopharmaceutical development and production responsible for making bottom-line driven
technology & services decisions all under one roof?
BPI continues to grow in sheer numbers and in the respect and praise it receives from the industry
– don’t miss out, contact us today to participate.
Customize Your Marketing Program to Meet Your Company’s Goals
With competition for the market’s attention stronger than ever, we understand that your company
needs to extend its reach beyond your booth in order to build relationships and connect with
attendees. BPI’s sponsorships offer a variety of ways for you to raise your company’s awareness in this
valued market both pre-show and on-site.
Maximize Your Outreach though Sponsorship Opportunities, including:
• Exhibit Booths – Only a handful still available!
• Web Seminar Sponsor – Brand NEW!
• Cocktail Reception Sponsor – Opening Night SOLD - Only 2nd night remaining!
• Pre-Event Online Partnering System Sponsor
• Session Sponsor – Connect Your Company Name with High Quality Scientific Content
• Technology Workshop Sponsor – Only a few remaining!
• Exhibit Hall Presentation Sponsor – Only One Remaining!
• Badge and Lanyard Sponsor – SOLD
• Breakfast or Luncheon Sponsor
• Padfolio Sponsor
• Conference Tote Bag Sponsor
• Registration Area Sponsor
Additional Sponsorship Opportunities:
Event Publications: Print & Electronic • Direct Mail • Special Events/Outings: Evening
Dinners, etc. • Conference CD-ROM and Post Event Presentation Website • Networking
Break Sponsorship • On-Site Banners & Signage • Site Tours • Water Bottles • Espresso
Café • Speaker Presentation Download Kiosk
To learn more about sponsoring or exhibiting at this year’s BioProcess
International Conference, please contact:
Kristen Schott, Sales Executive at (508) 614-1239 or kschott@ibcusa.com
Jennifer McElligott, Sales Executive at (508) 614-1672 or jmcelligott@ibcusa.com
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To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
The Most Extensive Biopharmaceutical Marketplace – Over 150 Vendors!
Exhibit Hall Hours
Tuesday, October 13, 2009 5:30 pm – 7:00 pm
Wednesday, October 14, 2009 9:45 am – 7:15 pm
Thursday, October 15, 2009 9:45 am – 3:45 pm
Exhibitor List (As of July 13 , 2009)
ABB Inc.
ABEC
Ace Glass*
AdvantaPure/ NewAge Industries*
Agilent Technologies, Inc.
Ajinomoto*
Alfa Laval
Alfa Wassermann Separation
Technologies LLC
Althea Technologies, Inc.
Applied Biosystems*
Applikon Biotechnology
Aragen Bioscience
Arkema Inc.*
Artelis*
Asahi Kasei Medical America, Inc.
ATMI*
ATR, Inc.
Avecia Biologics
Avid Bioservices
BAC B.V.
Baxter
BD Biosciences-Advanced
Bioprocessing*
BIA Separations*
Bio-G
Bioengineering, Inc.
Biolog
BioPharm Services
BioPro International*
BioProcess International™ Magazine*
Bio-Process Systems Alliance
Bio-Rad Laboratories
BioReliance*
Bioresearcy Online
BioScale
BioSpace
BioSystem Development, LLC*
BioTechLogic, Inc.
BlueSens*
Boehringer Ingelheim GmbH
Brightwell Technologies Inc.*
Broadley-James Corp.*
Catalent Pharma Solutions
Celeros Separations
Charles River
Charter Medical
CMC Biologics*
Cobra Biomanufacturing
Cogenics, Inc.
Colder Products
Commissioning Agents, Inc.
Cook Pharmica
Corning Inc.*
CUNO Inc. a 3M company*
Cygnus Technologies, Inc.
Cyntellect*
Cytovance Biologics*
DASGIP BioTools, LLC*
DCI
Dionex Corporation
Diosynth Biotechnology
DMV International
Doe & Ingalls of North Carolina
DSM Biologics*
Eden Biodesign
EMD*
Finesse Solutions
Flownamics, Inc.*
Fluid Imaging Technologies, Inc.
FOGALE nanotech Inc.*
ForteBio*
GE Healthcare
GEA Westfalia Separator, Inc.
Goodwin Biotechnology, Inc.
Gore PharmBio Products
Gyros Inc.
A rapidly growing event with technology-driven and interactive attractions that include:
•
•
•
•
•
•
roduct demonstrations featuring novel approaches, scientific content and the latest advancements
P
Themed roundtable discussions on the most timely subject matter
New product launches
Scientific poster presentations
Enjoyable networking lunches, breaks and receptions
Areas to connect with those you have been in contact with prior to the event using the online
networking tool
• Biospace Career Fair – co-located event
• Focused workshops to engage you in cutting-edge technologies and services
optek-Danulat
Hamilton Company*
Spectrum Laboratories*
Pall Life Sciences
IDBS
SynCo Bio Partners
Paragon BioServices, Inc.
Innovatis Inc.*
Symyx Technologies, Inc.*
Patheon Inc.
InVitria
Tarpon Biosystems
PBS Biotech, Inc.*
Invitrogen
TECAN
Pfenex,
Inc.
Irvine Scientific*
TechniKrom, Inc.*
Pneumatic Scale
JSR Micro, Inc.*
The Automation Partnership*
Praxair*
KBI Biopharma, Inc.
Thermo Scientific
PreSens Precision Sensing*
Kerry-Sheffield Pharma Ingredients
Thermo Scientific
ProMetic
BioSciences
Lancaster Laboratories, Inc.
TNO*
QSV Biologics
Laureate Pharma
Tosoh Bioscience LLC
Refine Technology, LLC
Lonza*
TTP LabTech
Rentschler Inc.
MediaTech Inc.
Value Plastics, Inc.*
Repligen
Corporation
Medicel Oy*
VirTis, an SP Industries Brand
SAFC Biosciences*
Metabolon, Inc.
Worthington Biochemical
Corporation*
Saint-Gobain Performance Plastics*
Millipore
WuXi AppTec, Inc.
SANDOZ GmbH
Natrix Separations, Inc.*
Xcellerex
Sartorius
Stedim
North
America
Inc.
*
NC State Universtiy - BTEC
YSI Inc.
SciLog,
Inc.
*
NCSRT, Inc.*
Seahorse
Bioscience,
Inc.
New Brunswick Scientific*
SEBRA*
North Carolina Biotechnology Center
NOVA Biomedical
NOVASEP*
* The companies that plan to launch New Products at BioProcess
International™ Conference & Exhibition are indicated with an asterisk *
Novozymes
Mark Your Calendar for 2010
September 20-24, 2010
Rhode Island Convention Center
Providence, RI
September 7-8, 2009
Westin Beijing Chaoyang Hotel
Beijing, China • www.IBCLifeSciences.com/BPIChina
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
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Call for Poster Submissions
Submit your abstract today at www.IBCLifeSciences.com/BPI
The organizers of BioProcess International™ Conference & Exhibition recognize
the significant educational value in poster presentations. Any registered and paid
conference attendee may sign up to present a poster. Poster fees: Industry: $100;
Academic/Government: Free.
• Space is limited to 75 posters
• Poster will be displayed by conference track
• Dedicated poster viewing times scheduled in the exhibit hall
• 15 poster abstracts will be published in a special event preview
• Visit www.IBCLifeSciences.com/BPI for more information
Call for Poster Deadlines
• For inclusion in Pre-Show and On-Site Event Guide (Published as a special
supplement to BPI Magazine September issue): July 31, 2009
• For inclusion in conference CD-ROM: September 21, 2009
Founding Publication
BioProcess International provides the biotechnology industry
with monthly, peer-reviewed information necessary to
successfully drive products through the biopharmaceutical,
biovaccine and biodiagnostic development and manufacture
process. BPI’s circulation consists of 30,017 mid-to-upper
managers working in all phases of the biotherapeutic
development and manufacturing process in the United States,
Europe and Canada.
For more information please visit www.bioprocessintl.com
Media Partners
Poster abstracts and registrations received after Monday, September 21, 2009 will
be subject to availability for an onsite poster board and will not be included in the
conference CD-ROM. Full payment of conference registration and poster fees must
also be received by Monday, September 21, 2009 for the abstract to be included in the
CD-ROM and poster assignment to be made. The size of the conference poster board
is 4'h x 8'w. Please note: Poster presentations may not be used as exhibit displays or
for marketing purposes. All posters are subject to approval by conference organizers.
Poster abstracts must be submitted online at www.IBCLifeSciences.com/BPI. Only one
poster presentation will be allowed per registered attendee/author.
Dedicated Poster Viewing
Wednesday, October 14, 2009 • 12:30 pm - 2:00 pm
Poster and Exhibit Viewing Hours
Tuesday, October 13, 2009 • 5:30 pm – 7:00 pm
Wednesday, October 14, 2009 • 9:45 am – 7:15 pm
Thursday, October 15, 2009 • 9:45 am – 3:45 pm
Conference Venue Information
Raleigh Convention Center 500 South Salisbury Street
Raleigh, NC 27601
Phone: (919) 996-8500
Fax: (919) 996-8550
Discounted Accommodations
Raleigh Marriott City Center (Connected to RCC)
500 Fayetteville Street
Raleigh, NC 27601
Phone: (919) 833-1120
www.marriottraleigh.com
Room Rate is $187 plus taxes
Sheraton Raleigh Hotel (One block from RCC)
421 S. Salisbury Street, Raleigh, NC 27601
Phone: (919) 834-9900 • www.sheraton.com/raleigh
Room Rate is $159 plus taxes
Please call either of the hotels directly before September 20, 2009 to be included in IBC's dedicated room block for this
conference. Please identify yourself as an IBC BioProcess International participant to qualify for the reduced rate. Be sure to make
your reservations as soon as possible as rooms tend to fill up very quickly and all reservations are subject to availability.
Featured Web Partner
Please review the following reservation policies:
1. A first and last night non-refundable deposit is required at the time of reservation.
2. C
ancellations and changes to a reservation will be accepted without further financial responsibility up until September 28,
2009. Your credit card is subject to being charged for your full reservation if cancellation or changes to a reservation are
received after September 28, 2009.
Supporting Associations
Affordable Travel Information
The recommended airport is the Raleigh/Durham International Airport (RDU) which is approximately 20 minutes from the BPI
venues. The estimated cab fare from the airport to the venues is $40 depending on traffic. As an alternative, you can contact
White Horse Transportation at 888-624-6773 to set up a non-stop car service. The one way trip from RDU to the venues provided
by White Horse transportation provides a flat fee of $35 for up to three people and $5 for each additional person.
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To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Registration Form
1
q Please register me for BioProcess International™ Conference and Exhibition
NAME
IB9171PDWDL
JOB TITLE
5 Easy Ways to Register!
(800) 390-4078
International Callers: US +1 941 554-3500
E-MAIL q Yes, I would like to receive occasional e-mail messages and offers from other organizations.
ORGANIZATION
DEPARTMENT
reg@ibcusa.com
MAILING ADDRESS
CITY
STATE POSTAL CODE COUNTRY
TELEPHONE
FAX
APPROVING MANAGER
Data Protection: The personal information shown on this form, and/or provided by you, will be held on a database and may be shared with companies in the Informa group in the UK and internationally. Sometimes your
details may be obtained from, or made available to, external companies for marketing purposes. If you do not wish for your details to be used for this purpose, please email data-admin@ibcusa.com.
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By July 17, 2009
By Augut 14, 2009 By Sept. 11, 2009
Select a Package
4-Day Conference Pass Plus Symposium (Mon.-Fri.) – BEST VALUE l n
(Includes Main Conference, Monday Pre-Conference Symposium)
Standard After Sept. 11, 2009
o $2499
o $2599
o $2699
o $2799
3-Day Conference Pass Plus Symposium (Tues.-Thur.) l n
o $2199
(Includes first 3 days of Main Conference, Monday Pre-Conference Symposium)
o $2299
o $2399
o $2499
4-Day Conference Pass Only (Tues.-Fri.) n
o $1999
o $2099
o $2199
o $2299
3-Day Conference Pass Only (o Tues.-Thur. OR o Thur.-Fri.) n
o $1699
o $1799
o $1899
o $1999
Training Course (Tues.-Wed.) & 2-Day Main Conference Pass (Thur.-Fri.) u n o $2299
o $2399
o $2499
o $2599
Pre-Conference Symposium (Mon.) & Training Course (Tues.-Wed.) u n
o $1999
o $1999
o $1999
o $1999
Training Course Only (Tues.-Wed.) u
o $1699
o $1699
o $1699
o $1699
Academic and government employees are eligible for over 40% savings off the above registration packages. Visit the registration page at
www.IBCLifeSciences.com/BPI for packages, pricing and to register. Academic/Government rate is extended to full-time employees of
government, universities, and university-affiliated hospitals only.
Add-on:
Reserve a Posterboard (space is limited)
o $100 Commercial
o FREE Academic/Government
Poster abstract must be submitted online at www.IBCLifeSciences.com/BPI by July 31, 2009 for inclusion in the BioProcess
International™ Pre-Show and On-site Event Guide or by September 21, 2009 for inclusion on the conference CD-ROM.
4
Please indicate if you would like to attend the Networking Dinner (Wednesday Evening) o $100
5
o #1: Technology Transfer
6
www.IBCLifeSciences.com/BPI
IBC USA Conferences, P.O. Box 414525,
Boston, MA 02241-4525
Additional Registration Information
For on-site registrations, please add $100.
Academic/Government Special Rates
3
(941) 365-0104
l Please indicate which Pre-Conference Symposium you plan to attend:
o #2: Practical Aspects of Implementing QbD
o #3: Driving Out Costs from Biomanufacturing
n Please indicate which track you primarily plan to attend: o #1. Manufacturing Efficiency and Supply Chain Security
o #2. Scaling Up from Bench through Commercialization
o #3. Cell Culture & Upstream Processing
o #4. Recovery & Purification
7
u Please indicate which course you plan to attend: o #1. Introduction to Biopharmaceutical Manufacturing
o #3. Transient Protein Production
o #2. Technology Transfer
8
Please Indicate if you would like to attend (Space for site tours is limited and available on a first come, first served basis.)
9
Payment
Information (Required 30 days in advance of the conference. If registering within 30 days, payment is due immediately)
o 1. Lonza Sponsored Session - FREE (Mon. 1:00 pm - 5:00 pm)
o 2. Diosynth Biotechnology Site Tour - FREE
(Wed. 8:15 am-12:00 pm)
o 3.Biogen
Idec Site Tour - FREE (Thur. 8:15 am - 11:30 am)
The tour to Biogen Idec is full but you can call customer service
at 800-390-4078 to add your name to the waiting list. Additional
spaces may become available.
r Mastercard r Visa r American Express r Check r Wire Transfer
Total: $_____________
Please make check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC USA Conferences and attach to the registration form. Confirmation of your booking
will be sent. Wire Transfer: Please tell your bank to include the conference code, invoice number, person attending, name and date of the conference in the
transfer instructions. Wire transfers and EFT payments: please contact accounts receivable at Account-liaison@informausa.com for banking details.
Card #
Exp. Date
Name (as appears on card)
Signature
CVV Code
Unable to Attend? Purchase the Conference Materials. Conference materials including a selection of speaker presentations will
be available for purchase following the event.
o I cannot attend and would like to purchase the conference materials. Enclosed is my payment for $399 (fee does not include shipping and
Unauthorized solicitation is strictly prohibited at this event and failure to
comply could result in revocation of your access privileges. This is a trade
only event. For your safety and security, a photo identification and industry
related business card are required at the conference check-in to complete
your registration.
Program content and speakers subject to change. Children under 18 are not
permitted in the exhibit hall under any circumstances. Conference badges are
non-transferable and lost badges will not be replaced without payment of the
full conference registration fee.
Please note that payment is required in advance of the conference. Please
make check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC Life
Sciences and attach to the registration form. Confirmation of your booking
will be sent. Should you elect to pay by MasterCard, Visa or American Express,
please send your credit card number, expiration date, name as it appears on
card and signature along with the registration form.
Registration Substitutions/Cancellations:
If you need to make any changes or have any questions, please feel free
to contact us via email at reg@ibcusa.com <mailto:reg@ibcusa.com> .
Cancellations must be in writing and must be received by IBC prior to 10
business days before the start of the event. Upon receipt of a timely cancellation
notice, IBC will issue a credit voucher for the full amount of your payment,
which may be applied towards registration fees at any future IBC event held
within 6 months after issuance (the "Expiration Date"). All credit vouchers shall
automatically expire on the Expiration Date and shall thereupon become void.
In lieu of issuance of a credit voucher, at your request, IBC will issue a refund
less a $595 processing fee per registration. Registrants are advised that no
credit vouchers or refunds will be issued for cancellations received less than ten
business days prior to start of the event, including cancellations due to weather
or other causes beyond the Registrant's control. IBC therefore recommends that
registrants allow for unexpected delays in making travel plans. Substitutions are
welcome at any time. If for any reason IBC decides to cancel this conference, IBC
accepts no responsibility for covering airfare, hotel or other costs incurred by
registrants, including delegates, sponsors, speakers and guests.
SPECIAL NEEDS: If you have a disability or special dietary needs, please let us
know in order that we may address your special needs for
your attendance at this show. Please send your special needs
via email to custserv@ibcusa.com or fax 508-616-5522. Group Discounts for Significant Savings!
Delegates can enjoy significant savings on standard
registration fees when registering for the BioProcess
International™ Conference and Exhibition by sending teams
to the event. IBC Life Sciences offers competitive discounted
rates for companies sending groups of 3 or more. For more
information, contact 646-895-7445.
Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event
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