ISPE NORDIC is pleased to invite You to a conference
Biotechnology
Know-how, Understanding and Future Trends
Date:
Venue:
21 May 2014
Biogen Idec, Biogen Idec Allé, Hillerød (Greater Copenhagen)
Who should attend?
Process Engineers, Quality Engineers, Quality Assurance and Project Managers.
We hope that You will book your calendars now, and remember to register for the event soon
as seats are limited.
For seminar registration please click here: http://www.bokonf.se/ISPE/Biotech/
If You have any questions regarding the seminar or registration, please contact:
Steven Davy, +45 3079 9806, sdvy@nnepharmaplan.com
Program:
08:00-08:30
Coffee, registration
08:30-08:50
Welcome (Steven Davy - ISPE Nordic)
08:50-09:35
Technical Talk 1: Facility of the Future, One Size Fits All? (Frank Nygaard, NNE
Pharmaplan)
09:35-10:20
10:20-10:30
Technical Talk 2: Hybrid Modelling (Moritz von Stosch, New University of Lisbon)
Exhibitors (Table Tops) Presentations
10:30-11:00
11:00-11:45
Coffee break and Table Top Exhibition
Technical Talk 3: H2O2 decontamination of Biopharm Facility (Steen Borup Jensen,
Rambøll Health & Pharma)
11:45-12:30
Technical Talk 4: Annex II Updates (Knud Rhyl, Pharma Partners)
12:30-13:30
Sum up of morning session, Lunch and Table Top Exhibition.
13:30-14:15
Technical Talk 5: Process Analytics Applications in Biotechnology (Henrik Toft,
Biogen Idec)
14:30-15:00
Networking break and Table Top Exhibition
15:00-16:15
Tour of Facility
16:15-16:30
Technical Sessions and closing comments, (Steven Davy)
Sponsor ad
The Biotechnology Conference 2014 intends to bring together people running and managing
biotechnology in Scandinavia. This is to include guests and speakers from small start-ups to major
biotechs, including the leading scientists, engineers and managers.
Althrough Europe has many conferences on topics relating to biotechnology, such as single-use
implantation, QbD, the changing regulatory background and process control, there have been very
few giving an overview of biotechnology as a whole. The first ISPE Europe conference in Strasbourg
last year was a huge success and ISPE Nordic Biotechnology CoP would like follow up on this.
Program Content – Details:
Technical Talk 1:
Facility for the Future, One Size Fits All?
(Frank Nygaard, NNE Pharmaplan)
Developments in the past decade within biotechnology demands different thinking when planning new
manufacturing facilities. It is not about the platform or equipment or construction methods that are
changing the way facilities are designed, but how facility designs are changing accommodate wide
bracket business requirements by being highly flexible and agile. This talk will outline some key
strategic consideration from different case studies evaluating trends in biomanufacturing and how this
is converging into the Facility of the Future.
Technical Talk 2:
Hybrid Modelling solutions for QbD and PAT in bioprocess
optimization (Moritz von Stosch, New University of Lisbon)
The PAT framework allows a more flexible process regulation if the impact of Critical Process
Parameters (CPPs) on the Critical Quality Attributes (CQAs) is (1) understood and (2) accounted for,
i.e. “to build in quality into the pharmaceutical manufacturing process.” The basis of QbD is to
understand the sources of variability in the process and product and to understand the linkages so
that variability can be controlled. In particular, the identification and assessment of CQAs and CPPs
requires an appropriate scientific model of the process. Such a model maintains required process
knowledge through the lifecycle of the drug. In the absence of readily available fundamental models,
typically Multivariate Data Analysis models are employed in the industry. However, those MVDA
models neglect the available, general valid knowledge from first-principles (e.g. mass conservation
laws). An alternative is the combination of the available knowledge from first-principles with MVDA
models in, so called, hybrid models. Due to the combination of different knowledge sources, hybrid
models typically award with decreased data requirements (in both quality and quantity) and they
inherit improved estimation and prediction performance. In a bioprocess optimization study we
compared the hybrid modeling solution to the other standard methods, namely a Response Surface
Model (RSM), a Partial Least Squares (PLS) model and an Artificial Neural Network (ANN), based on
(1) the number of experiments required for reaching the optimum; and (2) the understanding that can
be inferred from the model. In this comparison it is observed that 70% fewer experiments are required
to reach the optimum applying the hybrid modeling method than with any of the other methods and
that besides assessing the sensitivities the hybrid model allows study of the effect of CPPs along the
process trajectory.
H2O2 decontamination of Biopharm Facility
(Steen Borup Jensen, Rambøll Health & Pharma)
To be able to transform a dedicated biopharmaceutical manufacturing facility to a multi-product
GMO/BSL 2 facility alternating between commercial production and clinical trial material on
campaign basis – validated procedures for cleaning and decontamination is needed. The overall
scope set by the client was to safely and reproducibly decontaminate enclosed areas like biosafety
cabinets, incubators, rooms and airlocks within a timeframe of 8 hours.
Technical Talk 3:
This presentation outlines the effort, thoughts and pitfalls during design, installation and
qualification of a central HPV (Hydrogen Peroxide Vapor) installation to yield a 6 log10 reduction
using Geobacillus stearothermophilus spores under worst-case conditions. During the presentation
we will go through topics like: Why HPV disinfection? Available systems, methodologies and supplier
selection, Material compatibility issues, Room configuration and integration , Process requirements
incl. OSHA PEL, Cycle development and validation approach, Challenges and learning points.
Technical Talk 4:
Annex II Updates
(Knud Ryhl, PharmaPartners)
Biopharmaceuticals are manufactured from a variety of sources and by a variety of methods.
The EU has put up guidelines for this manufacture, guidelines which have existed for many
years, but have been modernized by the issue of the recent annex 2 to EU GMP in 2013.
This talk will compare the differences between the old annex 2 and the current, and also look
at some of the consequences of the new annex.
Technical Talk 5:
Process Analytics Applications in Biotechnology
(Henrik Toft, Biogen Idec)
Transitioning from reactive to proactive process monitoring requires a more advanced
toolbox. The benefits are easy to spot as improved real-time process monitoring becomes
available through the application of multivariate techniques allowing for rapid response
should an excursion occur. With improved process understanding a whole new paradigm of
production becomes available. Current practices, considerations and what the future brings
for the use of process analytics applications at Biogen Idec will be described
Sponsor ad
About the Speakers:
Frank is a Senior Technology Partner for bioprocess and technology within the
Business Development Group in NNE Pharmaplan. Frank has more than 10 years
of R&D experience from the biotech industry with a broad background within
manufacturing and analysis of protein therapeutics including monoclonal
antibodies. He holds a MSc in Biochemistry and a PhD in Protein Chemistry from
the University of Copenhagen.
During his professional career at NNE Pharmaplan, Frank has contributed to the
development of several conceptual designs for flexible manufacturing
biopharmaceuticals using single use technology.
Moritz von Stosch is the CEO and Founder of HybPAT, a company that provides
Hybrid modeling solutions for an efficient implementation of PAT, and he also
works as a researcher at the Systems Biology and Engineering group, University
Nova de Lisboa.
In 2011 he earned his PhD at the Faculty of Engineering of the University of Porto.
He was awarded his Diploma in Engineering from the RWTH-Aachen University in
Germany.
Moritz von Stosch is the author of several publications on hybrid modeling and a
leading expert on hybrid models and their application to bioprocess.
Steen Borup Jensen is senior process manager at Rambøll Health & Pharma. He
has accomplished a wide range of professional competencies within business
development, leadership and project management. For the past 15 years Steen
has worked as an consultant for the pharmaceutical industry and has a solid
background in project management, QA services, clean utilities, piping, various
manufacturing equipment, tender and tender evaluation, contract negotiation,
planning and control of economy, time and quality. Steen has a wide experience
as a project engineer on both large and smaller pharmaceutical projects. His
experience is gained primarely from piping, design of clean utility installations and
QA services including preparation of User Requirement Specifications and
executing of DQ, IQ, OQ and PQ.
Knud Ryhl Bjørnsson, known as Knudi, works with Pharmapartner as GMP
consultant. He has a MSc in Chemistry from DTU (Danish Technical Univercity) in
2003. Knudi started his carrier at various medicinal manufactures, working with
construction of new facilities.
In 2003 he became an ISPE Certified GMP Auditor and then he got employment at
DHMA (Danish Health and Medicines Authority) as Medicines Inspector, working
with inspections and approvals of pharmaceutical production facilities according to
EU GMP.
Since 2012 Knudi has worked as an indepentant consultant in GMP area,
assisting medicinal manufacturers in complying with GMP.
Henrik Toft, MSc, PhD, has for the past 15 years been working with application
and algorithm development for multivariate analysis of various spectroscopies in
both academia and industry. During the last two years as Process Analytics
scientist at Biogen Idec in Hillerød, Denmark, his focus has changed towards
process monitoring and advanced process control initiatives.
Registration:
Please register at: http://www.bokonf.se/ISPE/Biotech/
The number of participants is limited. Seats are allocated on a first come, first served principal.
Conference Fee:
Category
Industry
Academia & Regulatory & YP
Students
Member
€ 420/DKK 3.150
€ 110/DKK 825
€ 75/DKK 585
Non-member
€ 660/DKK 4.950*)
€ 210/DKK 1.575*)
€ 100/DKK 750*)
*) Includes a 1 year membership in ISPE
Table Top Exhibition:
This conference is an excellent opportunity to meet people working with all kinds of aspects within
Biotechnology and Pharmaceutical Production. We can offer a limited number of table top exihibition
possibilities for only € 500 (excl. conference fee). Contact us for further information.
Location: Biogen Idec, Biogen Idec Alle, 3400 Hilleroed, Denmark
Questions regarding registration:
B.O. Conference Service, Bengt Österlund; info@bo-conf.com, +46 705 320438
Questions regarding the event:
Steven Davy (ISPE Nordic Biotechnology COP Chair), SDVY@nnepharmaplan.com, +45 3079 9806
Event sponsors: