Program Information - IBC Life Sciences

Thursday, September 23, 2010
7:00 Coffee
7:15 Technology Workshop (Light Continental Breakfast Will Be Served) (Rotunda)
Are Your ANIMAL FREE Raw Materials Really Animal Free
This workshop discusses the approach BD Biosciences-Advanced Bioprocessing is taking to address this question.
Michael J. Titus, Ph.D., Director, Quality Management & Regulatory Compliance, BD Biosciences -Advanced Processing
Recovery & Purification
Cell Culture &
Upstream Processing
Emerging Analytical
Requirements (Room 551)
Plenary Session – Integration of Upstream and Downstream Processing
(Room Ballroom B/C)
8:00 Chairperson’s Opening Remarks
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corporation
8:15 Challenges and Efficiencies Gained by Integrating Upstream and
Downstream Drug Substance PD
Gene Schaefer, Ph.D., Senior Director, API-Large Molecule Development, Johnson & Johnson
8:45 Optimizing Interfaces and Hand-offs between Upstream
and Downstream Processing
Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head,
Isolation & Purification Department, Global Biological Development, Bayer HealthCare
9:15 Linking Upstream and Downstream
Jonathan Coffman, Ph.D., Principal Engineer III, Pfizer Biotherapeutics
9:45 Networking Refreshment Break in Exhibit and Poster Hall
Recovery & Purification
(Ballroom B/C)
Breakthroughs to De-Bottleneck
Downstream Processing
Chairperson: Jens H. Vogel, Ph.D., Global CMC Development
Team Leader & Head, Isolation & Purification Department,
Global Biological Development, Bayer HealthCare
10:30 Evaluation of Single Pass TFF to
Debottleneck Downstream Processing
of Monoclonal Antibodies
Jemelle Dizon-Maspat, Senior Research Associate,
Genentech, Inc.
11:00 Downstream Breakthroughs in
Downstream Processing of High Titer
and Cell Density Harvests
Blanca Lain, Senior Scientist, Downstream Process
Development, Percivia, LLC
11:30 Process Design and Facility Fit
Optimization Models for Higher Titer
Purification of Monoclonal Antibodies
Nuno Fontes, Ph.D., Senior Engineer, Group
Leader, Genentech, Inc.
Cell Culture & Upstream
Processing (Ballroom D/E)
Accelerating & Optimizing
Cell Culture & Process Development
Chairperson: Charles Sardonini, Ph.D., Associate Director,
Process Engineering/Development, Genzyme Corporation
10:30 CASE STUDY Rapid Generation of
High-Producing Clonal Cell Lines for
Recombinant Monoclonal Antibody
Manufacture
Jolanda Gerritsen, Technical Expert, Cell Line
Development, Genmab, The Netherlands
11:00 Scale Down Approaches to Facilitate
CHO Clone Development for High-
Level mAb Expression
Gareth Lewis, Ph.D., Scientist II,
MedImmune, United Kingdom
11:30 Boosting Yield, Speeding Up Process
Development and Improving Quality by
Process Intensification in Mammalian
Cell Culture
Rolf Douwenga, Vice President, Global R&D,
DSM Biologics, The Netherlands
Emerging Analytical Requirements
and their Impact on Process
Development and Manufacturing
8:00 Chairperson’s Remarks
Ciaran Brady, Ph.D., Associate Director,
Biopharmaceutical Development,
Human Genome Sciences Inc.
8:15 FDA Expectations Regarding
Bioburden Control in Biotech Processes
Patricia F. Hughes, Ph.D.,
Biotech Manufacturing Team, Office of Compliance,
CDER, U.S. Food and Drug Administration
8:45 New, Unpublished Data
CASE STUDY Methods for Analysis of
Subvisible Particles and the Utility in
Biopharmaceutical Process Evaluations
Tristan Marshall, Research Associate III,
Human Genome Sciences
9:15 Acidic Variants of Antibodies:
Characteristics and PK Properties
Paul Motchnik, Ph.D., Associate Director, Protein
Analytical Chemistry, Genentech, Inc.
9:45 Networking Refreshment Break in Exhibit
and Poster Hall
10:30 Analytical Strategies for Monitoring
Impurities Encountered in
Bioprocessing
Jon S. Kauffman, Ph.D., Director, Method
Development & Validation and Biopharmaceutical
Services, Lancaster Laboratories
11:00 The Potency Assay -- Still Relevant
after All These Years
Sally Seaver, Ph.D., President, Seaver Associates, LLC
11:30 Audience Interactive Panel Discussion
with All Session Presenters
Site Tour to Amgen’s BioNext Facility
Please arrive for the site tour at 3:45pm at the Sabin Street entrance on the Lobby level. Bus will depart promptly
at 4:00pm. You will return to the Rhode Island Convention Center at 6:30pm.
Pre-registration is required.
Thursday, September 23 • 4:00 pm – 6:30 pm
Amgen’s manufacturing plant in West Greenwich, RI, is a four-story, 364,000-square-foot building that contains
state-of-the-art manufacturing, production, warehousing, utilities, and office space areas. Built in 2004
to provide manufacturing capacity for Enbrel®, the plant operates 24 hours a day, seven days a week. The
plant provides a controlled environment for the manufacture of bulk drug substance. Tour participants will
walk through the plant and view through windows some of the production suites, including upstream and
downstream manufacturing areas, and will hear from Amgen staff about processes in these areas.
Closed-toed shoes must be worn; no high heels are allowed.
Check in at attendee registration desk by Wednesday at 2:00 pm if you are pre-registered or would like to attend.
14 www.IBCLifeSciences.com/BPI