Program Information - IBC Life Sciences

Symposium #1:
Prevention of Microbial and Viral
Contamination of Mammalian
Cell Culture Processes
Lessons Learned and Case Studies
(Room 554)
1:00 Chairperson’s Remarks
Robert D. Kiss, Ph.D., P.E., Director, Late Stage
Cell Culture - Pharma Technical Development,
Genentech, Inc.
1:15 How to Prevent Microbial Contaminations
of Bioreactors, and Successful Strategies
for Addressing Them if/when They Occur
Andrew Brewer, Senior Engineer, Biologics
Manufacturing Science and Technology,
Genentech, Inc.
1:45 CSI GMP Production; Lessons from
the Contamination Scene
Katie Stewart, M.S., Technical Training Supervisor,
Technical Training, Human Genome Sciences Inc.
2:15 CASE STUDY Microbial Contamination
in a CHO Based Production Culture
– A Case Study
Jim McColgan, Associate Director, Pilot Lab and
Production Operations, Pfizer Global Manufacturing
2:45 Networking Refreshment Break
3:15 Successful Elimination of Parvovirus
(MVM) Infections of Industrial Scale
Cell Cultures – Two Case Studies
Tim Hughes, Director, Processes & GMP Facilities,
CSL Ltd., Australia
3:45 Inactivation of Viruses and Mycoplasma
by Several Barrier Methods
Houman Dehghani, Ph.D. Principal Scientist,
Biosafety Development Group, Amgen Inc.
4:15 Audience Interactive Panel Discussion
5:00 Close of Symposium
Monday, September 20, 2010 • Pre-Conference Symposia
12:00 Registration (Exhibit Hall Foyer)
Symposium #2:
How Much Data is Enough
The Statistical Approach
to Process Validation
(Ballroom C)
1:00 Chairpersons’ Remarks
Ali M. Afnan, Ph.D., Principal, Step Change
Pharma, Inc.; Former Senior Staff Fellow, OPS,
CDER, US FDA
1:05 Statistical Assurance of Process
Knowledge and Control: The Means to
a Validated Process
Ali M. Afnan, Ph.D., Principal, Step Change
Pharma, Inc.; Former Senior Staff Fellow, OPS,
CDER, US FDA
1:50 Elements of a Quality by Design
Approach for Biopharmaceutical Drug
Substance Bioprocesses
Nathan McKnight, Ph.D., Senior Engineer,
Late Stage Cell Culture, Genentech, Inc.
2:35 Networking Refreshment Break
3:00 New, Unpublished Data
CASE STUDY Process Understanding:
How do We Demonstrate that We
Know What We Know
Carl A. Anderson, Ph.D., Associate Professor of
Pharmaceutical Sciences, Duquesne University
3:45 Strategies for Multi-Variate Studies of
Critical Process Parameters
Ronald D. Snee, Ph.D., Founder and President,
Snee Associates
4:30 Audience Interactive Panel Discussion
5:00 Close of Symposium
Symposium #3:
Technology Transfer for
Biopharmaceuticals
(Ballroom E)
1:00 Chairperson’s Remarks
Jean Bender, Ph.D., Principal Engineer,
Genentech, Inc.
1:15 Technology Transfer from
Development to Manufacturing
John Knighton, MBA, Director, Pharmaceutical
Development & Manufacturing Sciences, Johnson &
Johnson Pharmaceutical Research & Development
1:45 Technology Transfer and Scale-up of
an Antibody Process
Magnus Glad, Ph.D., Senior Project Manager,
Biopharmacy & Protein Technology,
BioInvent International, Sweden
2:15 Technology Transfers: Internal versus
External, Domestic versus International
Younok Dumortier Shin, Ph.D., Technical Lead,
Manufacturing Technology, Bristol-Myers Squibb
2:45 Networking Refreshment Break
3:15 Applying Principles of Operational
Excellence in Managing Technology
Transfer Projects
Greg Zarick, M.S., PMP, Associate Director of
Project Management, Lonza Biologics, Inc.
Michael J. Gorman, M.S., Certified Lean Six
Sigma Black Belt and Project Manager, Operational
Excellence, Lonza Biologics, Inc.
3:45 Integration of Quality Risk
Management into Technology Transfer
Lori Richter, Quality Risk Management Associate,
Global Quality Risk Management, Genentech, Inc.
4:15 Audience Interactive Panel Discussion
5:00 Close of Symposium
Two Day Training Courses • Tuesday, September 21, 2010 - Wednesday, September 22, 2010
Introduction to
Biopharmaceutical Manufacturing
(Room 554A)
Scott M. Wheelwright, Ph.D., President and CEO,
Strategic Manufacturing Worldwide, Inc.
Bioprocess Training Academy
Protein Characterization for
Biotechnology Product Development
(Room 558A)
Christine P. Chan, Ph.D., Senior Manager, Technology Development,
Genzyme Corporation
Cell Culture and Fermentation Bioprocessing
(Room 554B)
Regulatory Compliance in CMC Development
(Room 558B)
Antonio R. Moreira, Ph.D., Professor, Chemical and Biochemical Engineering,
Vice Provost, University of Maryland, Baltimore County
Bruce K. Burnett, Ph.D., RAC (US, EU), Director, Regulatory Affairs,
Duke University
Sneak Preview: Be the first to visit the newest Xcellerex FlexFactory
Tuesday, September 21st at 12noon
Please join Xcellerex and IBC for a tour of our newly completed FlexFactory® facility
in Marlborough, Massachusetts. This biomanufacturing facility will open for GMP
production in October, less than 6 months from completion of final design. The
facility, which encompasses upstream and downstream operations, demonstrates
the unprecedented speed at which new capacity can be achieved with FlexFactory
technology. Coach transportation will be provided, at 12:00 noon on Tuesday,
September 21. Please register for the Site Tour at the BPI Registration Area.
BioProcess International Conference & Exhibition 7