TAMPA, FL
PERMIT NO. 2661
Don’t miss The Global Evolution of Aseptic Processing: Implementing
Risk-Based Manufacturing Solutions Conference. ISPE has taken
conferences to the next level to make them more interactive and topic-specific
to meet your industry needs. The Aseptic Processing Conference tracks will
focus on understanding new-age product requirements and industry
trends, implementing risk-based initiatives, applying QbD concepts,
reducing production costs, improving product stability, and simplifying
validation.
NON-PROFIT ORG.
U.S. POSTAGE
PAID
CONFERENCE OVERVIEW
Aseptic Processing Conference Program Committee
Special thanks go to the Aseptic Processing Conference Program Committee for their expertise and
time in creating this outstanding professional development opportunity for ISPE.
ISPE Future Visioning Team Liaison
Andrew Signore, Integrated Project Services (IPS), USA
Industry Co-Chair and Keynote Speaker Udo J. Vetter, Vetter Pharma Fertigung GmbH & Co. KG
Track Leader: Barrier Isolation
Jack Lysfjord, Lysfjord Consulting LLC, USA
Track Leader: Vaccine Manufacturing
Jeff Biskup, CRB Consulting Engineers, Inc., USA
Track Leader: Technology Innovations
Jörg Zimmermann, Vetter Pharma Fertigung GmbH & Co. KG
Subject Matter Expert
Berthold Duethorn, Robert Bosch GmbH, Germany
Subject Matter Expert Ryan Hawkins, Cook Pharmica, USA
The Global
Evolution
of Aseptic
Processing:
conference Schedule-At-A-Glance
Want to “Meet the Authors?”
View the recorded webinar featuring the Sterile Guide
Authors. You’ll hear a panel discussion on technical updates
contained in the Guide and best practice recommendations
on Sterile Manufacturing Facility Design.
Visit www.ISPE.org/AsepticConference for
more information.
29 February – 1 March 2012
Grand Hyatt Tampa Bay
Tampa, Florida USA
Grand Hyatt Tampa Bay
Tampa, Florida USA
For full agenda, visit www.ISPE.org/AsepticConference.
Implementing Risk-Based
Manufacturing Solutions
29 February – 1 March 2012
07.00 – 08.30Continental Breakfast
08.30 – 17.00 Track 1: Barrier Isolation
Track 2: Aseptic Technologies for Vaccine Manufacturing
Track 3: Technology Innovations in Aseptic Processing
Implementing Risk-Based
Manufacturing Solutions
Thursday, 1 March
The Global
Evolution of Aseptic
Processing:
07.30 – 08.45New Member/First-Time Attendee Breakfast
07.30 – 08.45 Continental Breakfast for all Delegates
09.00 – 12.30
Keynote Presentations
William Weidersiem, President & CEO, PharmaBioSource, Inc., USA
The Market For Parenteral Products and Facilities
Udo J. Vetter, Vetter Pharma Fertigung GmbH & Co. KG
Why Vaccines Are No Longer in Vials
Mark Von Stwolinski, Vice President Architectural Services, CRB
Consulting Engineers, Inc., USA
Special Presentation on the ISPE Sterile Guide by Co-Author
12.30 – 13.30
Lunch
13.30 – 17.00 Track 1: Barrier Isolation
Track 2: Aseptic Technologies for Vaccine Manufacturing
Track 3: Technology Innovations in Aseptic Processing
17.00 – 18.30Evening Reception in Exhibit Hall
600 N. Westshore Blvd. | Suite 900
Tampa, Florida 33609 | USA
Wednesday, 29 February
The NEW ISPE Sterile Product
Manufacturing Facilities Guide will
be integrated into the content of
each track, and a complimentary
copy of the Guide will be given to
registrants!
Learn from leading
manufacturing
experts as they
apply state-ofthe-art solutions
to the challenges
of manufacturing
specialty
pharmaceutical
products through
innovative aseptic
processing
technologies.
ISPE PINNACLE PROGRAMME
2012 Global Sponsor
Sponsorship Opportunities Available
Sponsoring an ISPE educational seminar or training
program is a cost-effective way to gain competitive
advantage, increase name recognition, and create
top-of-mind awareness in today’s pharmaceutical
science and biotechnology manufacturing industry.
Sponsorships include pre-event exposure on the
ISPE website as well as the delegate mailing
list, onsite exposure with exhibit opportunities,
company logo on signage, and mentions in
print and electronic communication. For more
information or to secure your sponsorships,
contact John Phillips at jphillips@ispe.org or
Daniel Murphy at dmurphy@ispe.org.
Technology Innovations in Aseptic
Processing
Share best practices through case studies on how to apply evolving technologies to meet production demands
(including those related to biohazard emergencies) and learn tactics to minimize dependence on clean rooms for
product integrity and worker safety.
Take a holistic approach on the production of parenteral drugs from API to final dosage forms. This session will
include an overview of what is involved in these processes and how to avoid pitfalls.
This session will address evolving issues relative to the current state of vaccine manufacturing, how the
industry is dealing with these challenges and how technologies are evolving to improve the business. There will
also be an emphasis on vaccine manufacturing strategies that might be useful in aseptic production of other
pharmaceuticals.
Various approaches and case studies will be presented. One key paradigm addressed will be the trend toward
reduction of the physical envelope around the process, and the advantages of “closing” processes. This
approach emphasizes the use of appropriate equipment, rather than relying on highly controlled facilities.
At the conclusion of this session, participants will be able to:
Barrier Isolation
Focus on technologies applicable to advanced aseptic processing using RABS and barrier isolation by
applying best practices from case studies. Hear from speakers from international companies present
topics of global importance through multiple case studies, and interactive workshops.
At the conclusion of this session, participants will be able to:
• U
nderstand technologies applicable to advanced aseptic processing using RABS and barrier isolation
from actual users and experts
• Interpret regulatory agency perspectives to improve your regulatory submission and approval process
• Identify costs related to the decision to use RABS or isolators for new and renovated facilities
• Network with others who are working on RABS and isolator projects
• Interact with vendors of RABS, isolators and process equipment for fill-finish of parenteral products
• U
nderstand and address current challenges in vaccine production
• Apply case study experience to current production processes
• Utilize new production technologies to improve product integrity and worker safety
Leader: Jeff Biskup, CRB Consulting Engineers, Inc., USA
Moderator: Lee Emel, CRB Consulting Engineers, Inc., USA
Wednesday, 29 February
anufacturing and Business Industry
M
Presentations:
• M
anufacturing Flexibility and Responsiveness in
Changing and Dynamic Markets: National and
Global Perspectives
Leader: Jack Lysfjord, Lysfjord Consulting, USA
Moderator: Ryan Hawkins, Cook Pharmica, USA
• Vaccine Industry Business Overview
Wednesday, 29 February
• Q
bD for Vaccines: FDA and EMA Progress
Dicky Abraham, Merck & Co., Inc. USA
L essons from Ten Years of Aseptic Processing
Under Isolators
Patrick Van Hecke, GlaxoSmithKline, Belgium
T wenty Years and Counting – Restricted
Access Barrier Systems (RABS)
Stewart Davenport, Pfizer, USA
C
ase Study - Isolated, High-Speed Syringe
Filling Line
Jerrod Shook, Novartis Vaccines, USA
P
otent Isolated Syringe Filling Line for Clinical
Trial Materials
Caroline Eichberger, Bristol Myers Squibb, USA
Thursday, 1 March
O
ptimization of Decontamination Cycle Time
for Barrier Isolator for Manufacturing of Protein
Based Drug Products
Michael Lee, Amgen, Puerto Rico
S
terile Toxic Bulk Powder Production and How
It Can Be Achieved
Ewart Richardson, DEC Group, Switzerland
D
ual Chamber Liquid/Powder Cartridge Filling
Line with a Barrier Isolator from Installation to
Microbiological Qualification
Tarek Kalaaji, Amylin, USA
R
etrofit of a Closed RABS for Aseptic
Cytotoxic Fill Operations at a CMO
Alan Matkins, DSM Pharmaceuticals, USA
F DA Perspectives on the Use of RABS
and Isolators
FDA, USA, Invited
Guidance and Trends Presentations:
• C
hallenges of the Influenza Industry
Manfred Brunen, Novartis, Germany
Thursday, 1 March
Future Vision Presentations:
• F uture Manufacturing Facility Design for Flexibility
Mark von Stwolinski, CRB Consulting Engineers, Inc., USA and George Dove, CRB
Consulting Engineers, Inc., USA
• A
pplying Risk-Based Assessments to Vaccine Manufacturing
M
arc Pelletier, CRB Consulting Engineers, Inc., USA
Solutions to Manufacturing Challenges:
• G
MP vs. Containment: How to Manage Conflicting
Agendas with Vaccine Facility Design
Norman Goldschmidt, Genesis, USA
• The
Role of CMOs in Supporting Global Vaccine Production Needs: Case Study - Brazil Fill Finish with Single Use
Rob Roy, Integrated Project Services (IPS), USA
and Jason Collins, Integrated Project Services
(IPS), USA
At the conclusion of this session, participants will be able to:
•
•
•
•
Understand the full range of processes involved in the production of parenteral drugs
Expand knowledge of processes outside individual production specialties
Work more effectively with all aspects of production processes
Apply state-of-the-art processing techniques in the production of advanced, innovative parenteral products
Leader: Jörg Zimmermann, Vetter Pharma Fertigung GmbH & Co. KG
Wednesday, 29 February
Innovations in API Manufacturing: Using Closed
Systems from Inocculum to Final Bulk
Dirk Böhm, Merck-Serono, Switzerland
A Case Study: Automating a Manual Cleaning
Process in an Aseptic Bio-Manufacturing Facility
John Spohn, Castlehilltech, USA
C
hallenges of Formulation and Fill-Finish
Process Transfer: Case Study for a Lyophilized
Protein Product
Arpan Nayak, Human Genome Sciences, Inc., USA
New Methods in Controlling Silicone Levels
Miraslov Horvat, Robert Bosch GmbH, Germany
Flexible Aseptic Manufacturing – Facility for Multi-
Format Fill /Finish Lines Utilizing Ready-to-Use
(RTU) Components and Containers
Josh Russel, Automated Systems of Tacoma, USA
and Steven Walter, CDI Life Sciences
Thursday, 1 March
A New Process for Closed Aseptic Powder
Transfers
Aaron Mertens, Atec Pharmatechnik, USA
Design
Requirements and Solutions for a High
Potent SVP Facility
Hartmut Schaz, NNE Pharmaplan, Germany
C
ontainment and Potent Product Facility
Ganesh Vyavahare, Reliance Biopharma, India
Fill-Finish
Processes for MABs: Challenges
and Solutions
Barbel Hinneburg, Vetter, Germany
Integrated
Approach – Pre-Filled Syringe Platform
Development at Eli Lilly
Ross Allen, Eli Lily, USA
Moving
an Auto Injector from Design Concept to
Commercialization
Eric Faulkner, BiogenIdec, USA
• P
erspectives of a Consumer of CMO Services in the Vaccine Industry
Olivier Jankowitsch, Intercell, Austria
• D
esign, Construction, Validation and Operation of a
BSL-2, Sporeformer Compliant Facility
Dino Muzzin, Emergent BioSolutions, USA and
George Dove, CRB Consulting Engineers, Inc., USA
• W
hat Can Human Vaccine Manufacturers Learn from Animal Health? A Case Study
• N
ew Equipment Approaches
Brady Cole, ABEC, USA, Invited
• S
terile Guide Review and Application for Vaccine Manufacturing
Mark von Stwolinski, CRB Consulting
Engineers, Inc., USA
F DA Question and Answer Session
FDA, USA, Invited
Extend Your Stay to Attend Professional Development Training
Aseptic Technologies for Vaccine
Manufacturing
Monday – Tuesday | 27 – 28 February 2012
Sterile Product Manufacturing Facilities: Applying the New
ISPE Baseline® Guide and FDA Guidance Principles to Design and
Operation New Course!
Do you know the key requirements and GMPs for sterile manufacturing facilities?
This course uses the newly published second edition of the ISPE Baseline® Guide: Sterile
Product Manufacturing Facilities and the FDA’s newly published Guidance for Industry: Sterile
Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to
provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.
Using the referenced documents, this course will cover regulatory philosophy, aseptic
process and equipment considerations, aseptic clean room design and operation, differential
pressure requirements, airlocks, basic utility systems, European HVAC considerations, basic
commissioning and qualification issues, and a brief introduction to barrier isolation technology.
Immediately apply the objectives using a complimentary copy of the ISPE Baseline® Guide:
Sterile Product Manufacturing Facilities.
Instructor: Gordon Farquharson, Principal, Critical Systems, Ltd., UK
Course Level: Intermediate
CEUs: 1.3
*The training course registration is not included in the conference registration fee.
Schedule at a Glance
Registration will be open from 07.00 – 17.00 on Monday and Tuesday.
Monday, 27 February
07.30 – 08.45New Member/First-Time Attendee Breakfast
09.00 – 17.00
Sterile Product Manufacturing Facilities
10.30 – 11.00Networking Break in Exhibit Hall
12.00 – 13.00
Lunch
14.30 – 15.15Networking Break in Exhibit Hall
17.00 – 18.30Evening Reception in Exhibit Hall
Tuesday, 28 February
09.00 – 17.00
Sterile Product Manufacturing Facilities
10.15 – 11.00Networking Break in Exhibit Hall
12.00 – 13.00
Lunch
14.15 – 15.00Networking Break in Exhibit Hall
New Course!
ISPE – Membership Has its Benefits
Did you know that ISPE Members attend training programs and other
events at discounted rates? New Member registration fees include a oneyear ISPE membership, a $239 value. Visit www.ISPE.org/Join for details
on Member benefits and special rates for Young Professionals, Students,
Regulators, and persons from countries with Emerging Economies.
How to Register
Online: Visit www.ISPE.org/AsepticConference
Via Fax: Complete the registration form online and fax it to: +1-813-264-2816
Via Mail:Complete the registration form online and mail it with payment to:
ISPE Headquarters, 600 N. Westshore Blvd., Suite 900,
Tampa, Florida 33609 USA
Questions? Call
ISPE at tel: +1-813-960-2105, or email: ask@ispe.org
Written confirmation will be sent to you after your registration is processed (time
permitting). In order to be listed in the official delegate roster, you must be
registered and paid by 6 February.
Hotel Information
www.ISPE.org/AsepticConference
New Course!
Hotel accommodations and hotel fees are separate from Conference registration fees. For room
reservations at the Conference venue, Grand Hyatt Tampa Bay, USA., call tel: +1-888-421-1442
or +1-402-592-6464. When making your reservation by phone, mention ISPE for a discounted
rate of $229 single/double. This rate is good until 6 February 2012, or until the room block is full,
whichever comes first. Please contact the hotel as early as possible to make your reservations to
ensure you are in the headquarters hotel.