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Monday, September 20, 2010 • Pre-Conference Symposia
12:00 Registration
Symposium #1: Prevention of Microbial and Viral
Contamination of Mammalian Cell Culture Processes
- Lessons Learned and Case Studies
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
Managing Manufacturing Networks
Symposium #2:
How Much Data is Enough The Statistical Approach
to Process Validation
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3:00 New, Unpublished Data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
Tuesday, September 21, 2010 • Main Conference
7:00 Registration and Coffee
Product Lifecycle Management
Symposium #3:
Technology Transfer for Biopharmaceuticals
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
Advancements and Case Studies of
Hydroxyapatite for Biomanufacturing
Leveraging our Assets – How Do We
Reconcile the Installed Base with
Current Technologies and Demand
7:55 Chairperson’s Remarks
Shishir Gadam, Ph.D., Director, Manufacturing Science and
Technology, Genentech, Inc.
Keynote Presentation
8:05 Optimizing Manufacturing Network
Performance and Planning for the Future
Biologics manufacturing network performance can
be measured across many dimensions including cost,
compliance, cycle time etc. It has been useful to consider
both plant and network parameters to optimize current state
performance. These parameters in addition to considerations of likely
business, technology and socioeconomic changes help shape our
thoughts for future biologics manufacturing.
Alison Moore, Ph.D., Vice President, Corporate Manufacturing,
Amgen
8:45 New, Unpublished Data
CASE STUDY Manufacturing Aspects of a New
Facility: Lessons Learned
Shakedown, qualification, and start-up of new biotech
manufacturing facilities is a challenging undertaking. Balancing
cost, schedule and resources is always a challenge. This talk will
review the lessons learned from the design, commissioning,
qualification, shakedown, and validation of numerous large scale
biotech manufacturing facilities, including process equipment and
automation lessons learned.
Jeff Johnson, Engineering Director, BioVaccine Process Engineering,
Global Engineering Services, Merck & Co., Inc.
9:15 Building the First Patient Specific Product
Manufacturing Plants: Design and Construction
of Dendreon Corporation’s Innovative
Manufacturing Facilities
Abstract not available at press date. Please visit
www.IBCLifeSciences.com/BPI for program updates.
Ken Hammer, Vice President, Facilities and Engineering,
Dendreon Corporation
9:45 Networking Refreshment Break
10:15 New, Unpublished Data
CASE STUDY Enabling High Throughput Production
in an Existing Commercial Plant
Lowering cost of goods is achievable by producing product at higher
run rates in an existing facility. This case study presentation focuses
on evaluation of historical performance to identify and implement
equipment and operational modifications to enable manufacture
of product at high run rates. The presentation will report on actual
performance after modifications were implemented. Implications for
design of future processes will also be discussed.
Carol D. Basey, Senior Manufacturing Technical Specialist,
Genentech, Inc.
Process Design: Establishing Design
Space and Robust Process Parameters
8:00 Chairperson’s Remarks
Duncan Low, Ph.D., Scientific Executive Director, Process
Development, Amgen, Inc.
8:15 CASE STUDY Developing an Appropriate Design
Space Strategy to Mitigate Variability in Downstream
Processing Operations
Lot to lot variability in chromatography adsorbent properties can
result in unacceptable performance. The column operating conditions
may need to be designed to be adsorbent lot specific to achieve
acceptable performance. In this presentation, we discuss how a
design space strategy can be used to mitigate such risks, by providing
additional flexibility in applying the appropriate column operating
conditions. Several case studies will be presented.
Justin McCue, Ph.D., Principal Engineer, Downstream Process
Development, Biogen Idec
8:45 Multivariate Data Analyses and Real-time
Multivariate Process Monitoring of Upstream
Operations in Biopharmaceutical Manufacturing
Biopharmaceutical processes generate large amount of data in
commercial operations that require advanced modeling and
monitoring. Multivariate technology allows quickly identifying
patterns in the process data to help facilitate process learning
and troubleshooting. Examples from large-scale manufacturing
applications in cell culture process monitoring approaches by using
real-time process supervision will be demonstrated.
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc
9:15 CASE STUDY Creating a QbD Chromatography
Design Space Using Mechanistic Modeling Techniques
The FDA has called QbD “a good scientific approach” which involves
“using good science” which “will result in cost benefits for the
industry”. This case study applies mechanistic modeling to identify
critical parameters and define an ICH/FDA Q8 compliant QbD
design space. Simulations were used to improve the separation,
reduce operating costs and troubleshoot separation anomalies.
Peter K. Watler, Ph.D., Chief Technology Officer,
Hyde Engineering + Consulting Inc.
9:45 Networking Refreshment Break
10:15 New, Unpublished Data
CASE STUDY Use of DOE to Determine Process
Parameters for a Robust Design Space in the
Formulation of a Biopharmaceutical Product
Design of experiments (DOE) tools in product and process
development can be confusing and frustrating, resulting in
missed opportunities for increased knowledge about the product
or process under consideration. This presentation will outline
general DOE concepts for factorial and fractional factorial
DOE’s and describe a DOE used to optimize the formulation of a
biopharmaceutical product.
Martin Kane, Associate Director Process Statistics, Department of
Biostatistics, Human Genome Sciences, Inc.
“This conference is invaluable for the quality of ideas
exchanged by the participants.”
– David Kolwyck, Technical Manager, SAFC, a division of Sigma Aldrich
Sponsored by:
8:00 am-12:00 pm
We are pleased to bring you a half-day technology workshop featuring
many of the world's leading authorities to discuss new advancements
and applications in separation science using hydroxyapatite and related
materials. In this session, we will discuss modern techniques for separation
and analysis of immunoglobulins, enzymes, and related biomolecules from
micropreparative to industrial scale. Speakers will present case studies
and the latest developments using hydroxyapatite in the manufacturing of
biopharmaceuticals. A roundtable discussion will conclude this workshop
highlighting key biomanufacturing topics and challenges today.
Topics & Presenters:
Dissociation of Antibody: DNA Complexes
by Hydroxyapatite
Pete Gagnon, Chief Scientific Officer, Validated Biosystems
Packing Ceramic Fluoroapatite at Multiple Process Scales
Jaclyn Shaffer, R&D Associate II, MedImmune
Methodology for Extension of Ceramic Hydroxyapatite
Column Lifetime
Mark A. Snyder, Ph.D., Process R&D Applications Manager,
Bio-Rad Laboratories
Ceramic Hydroxyapatite Usage in Process Manufacturing
Norbert Schuelke, Ph.D., Associate Director, Millennium
Pharmaceuticals, Inc.
Best Practices for Packing Ceramic Hydroxyapatite at
Process Scale
Kim Brisack, M.S., Staff Scientist, Bio-Rad Laboratories
Key industry leaders to present additional case studies
Roundtable Discussion
• Downstream process of monoclonal antibodies
• Scale-up and optimization of hydroxyapatite, handling and
qualification testing
• Chemical robustness of ceramic hydroxyapatite
• Application of hydroxyapatite in vaccine production
Visit www.IBCLifeSciences.com/BPI
for complete session details
5 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com