Program Information - IBC Life Sciences

Managing Manufacturing
Networks (Ballroom B/C)
9:15 New, Unpublished Data
CASE STUDY Development
and Implementation
of a Next-Generation
Manufacturing Process for a
New rFVIII Product
Dr. Jens H. Vogel, Global CMC
Development Team Leader and
Head, Isolation and Purification,
Bayer Healthcare
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
10:30 Subcutaneous Protein
Delivery: Challenges,
Opportunities, and Key
Lessons from a Drug
Delivery Platform
Michael J. LaBarre, Ph.D., Vice
President, Product Development,
Halozyme Therapeutics, Inc.
11:00 New, Unpublished Data
CASE STUDY Biodefense:
Human Genome Sciences’
Development and
Manufacture of an Antibody
for Treatment of Anthrax
Delivered to the Strategic
National Stockpile
Craig Malzahn, Director, Supply
Chain / Manufacturing Operations,
Human Genome Sciences, Inc.
11:30 Upgrading Current
Facilities for Future
High Titer Processes
Rich Meinel, Associate Director
Global Process Engineering
Technology, Biogen Idec
Product Lifecycle
Management (Ballroom D/E)
9:15 Humira Downstream
Process: Challenges in
Continuous Improvement
and Technical Transfer
Helen Yang, Technical Operations,
Abbott Bioresearch Center
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
10:30 New, Unpublished Data
CASE STUDY Utilization
of QbD Principles for the
Management of
Post-Approval Changes
Marc Better, Ph.D., Executive Director,
Process Development, Amgen Inc.
11:00 New, Unpublished Data
CASE STUDY Advanced
Process Control and
Real-Time Chromatography
Monitoring
Robert Genduso, Scientist II,
Biogen Idec
11:30 New, Unpublished Data
Design of a Contamination
Barrier for Serum-Containing
Cell Culture Media of a
Licensed Product
R. Michael Boychyn, Ph.D., Principal
Engineer, Amgen Colorado Process
Development, Amgen Inc.
Room 552
Achieving Reproducible Manufacturing
Outcomes through the Use of
Scale-down Models
The use of accurate scale down modeling ensures that lab data represent the
manufacturing case when transferring bioprocesses between sites. Diosynth has used a
lab scale fermentation model to accurately reflect manufacturing operations, leading to
successful scaling of five microbial processes over the last two years. Discussion will center
upon how and when to use scale-down models to achieve reliable manufacturing results.
Raghu Shivappa, Ph.D., Fermentation Team Leader, Upstream Process Development,
Diosynth Biotechnology, now a part of MERCK BioManufacturing Network
Stewart McNaull, Ph.D., Section Leader, Upstream Process Development,
Diosynth Biotechnology, now a part of MERCK BioManufacturing Network
Room 551
Fully Disposable, Multiple mAb Processing
for Clinical Trials
A step-by-step review of a typical mAb platform process from
inoculation to final filtration will provide solutions for single- or
campaign-use technology as well as technical and economical criteria
to decide what the best alternative would be: a classic equipment setup or the
disposable option.
Jonathan Royce, Category Leader Bioprocess, GE Healthcare Life Sciences
Luncheon Roundtable
Discussion Topics:
Wednesday, September 22, 2010 (continued)
Raw Materials/Supply
Chain (Room 551)
8:55 Global Adventitious Agent
Regulations of Raw Materials
Used in Biopharmaceutical
Manufacturing
Barbara Potts, Ph.D.,
Senior Consultant,
Biologics Consulting Group, Inc.
Co-author: T.W. Tanaka
9:20 New, Unpublished Data
CASE STUDY Supplier
Perspective on Risk
Assessment and Management
of Critical Raw Materials
for the Manufacture of
Biological Therapeutics
David Kolwyck, Technical Manager,
SAFC, a division of Sigma Aldrich
9:45 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
10:30 Implementing a Raw Materials/
Supplier Management Risk
Mitigation Strategy with
Limited Resources
Paula Shadle, Ph.D.,
Principal Consultant,
Shadle Consulting Services
10:55 New Applications of Analytical
Methodologies for Raw
Material Characterization
Maureen Lanan, Ph.D., Principal
Scientist, Analytical Development,
Biogen Idec
11:20 Audience Interactive
Panel Discussion with
All Session Presenters
Strategy
Discussion Forums
(Rotunda)
Sponsored by
12:30 Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing and Roundtable Discussions
Poster presenters are requested to stand by their posters for discussion.
12 www.IBCLifeSciences.com/BPI
12:00 Concurrent Technology Workshops
1. Is process development dead for antibodies
2. Can we be more flexible and efficient with our facilities
3. What are the future drivers for upstream process development
4. What does the future hold for automation in bioprocessing
10:30 Continuous
Disposable Multi-Column
Chromatography:
Emerging Technology
to Enable More Efficient
Downstream Processing
Station 1:
Economic Modeling
of Multi-Column
Chromatography
Applications
Facilitator:
Peter Latham, President,
Latham BioPharm Group
Station 2:
QA Discussion of Areas
Relating to Multi-Columns
Operations
Facilitator:
Art Rankis, Quality and
Regulatory Consultant
Station 3:
Modeling your Clinical
Manufacturing Process
Facilitator:
Marc Bisschops, Scientific
Director, Tarpon Biosystems
Station 4:
Adoption of New
Technologies into
Organizations
Facilitator:
Scott Fulton, Founder & CEO,
BioSystem Development, LLC
Room 550
Relieving Bottlenecks in Downstream Purification:
Further Advances in Membrane Chromatography
Part 1: Dr. Carl Lawton will present his recent work on scaling up
purification of E. coli expressed proteins using single step capture
and clarification.
Carl W. Lawton, Ph.D. Associate Professor, Biological Engineering Program Coordinator,
Director, Massachusetts BioManufacturing Center (MBMC)
Part 2: Novel Chemistries for High-Capacity / High-Throughput Single-Use Membrane
Chromatography
C. Howie Honeyman, Ph.D., Vice President, Research and Product Development, Natrix
Separations Inc.
Room 553
CelliGen BLU: How New Brunswick has
Combined the Performance of Stirred Tank
Technology with the Benefits of Single-Use
The CelliGen BLU is New Brunswick’s newest offering in the benchtop bioreactor and fermentor
family of products. Positioned as a novel system offering 5.0L or 14.0L stirred tank single-use
vessels; this system mimics traditional autoclavable technology while providing all the benefits of
disposable technology. The CelliGen BLU will meet the demands of the single-use system users
not satisfied with the current bench scale single-use bioreactors available on the market.
Richard Mirro, Product Manager, New Brunswick Scientific
5. Are we replacing one set of problems for another with chemically-defined media
6. What are the best strategies for resolving downstream bottlenecks
7. Is there a realistic scenario to launch generic monoclonal antibody drugs