Program Information - IBC Life Sciences

Tuesday, September 21, 2010
7:00 Registration and Coffee
Managing Manufacturing Networks
(Ballroom B/C)
Product Lifecycle Management
(Ballroom D/E)
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
Alison Moore, Ph.D., Vice President, Corporate Manufacturing,
Amgen
8:45 New, Unpublished Data
CASE STUDY Manufacturing Aspects of a New Facility:
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
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10:15 New, Unpublished Data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
Carol D. Basey, Senior Manufacturing Technical Specialist, Genentech, Inc.
10:45 New, Unpublished Data
CASE STUDY The Dinosaurs Reborn: Retrofitting
Existing Facilities to Speed Tech Transfer and Support
the Platform Process
Rick Johnston, Co-Director, Center for Biopharmaceutical Operations,
University of California, Berkeley
11:15 How Process Simulation is used in Biogen Idec to Optimize
Manufacturing Processes
Ian Gosling, Ph.D., Principal, ChemSim LLC
Room 553
Key Considerations when
Screening Supplements
for Medium Optimization
The contribution of protein hydrolysates to the
performance of a biopharmaceutical production system
is largely medium dependent. The improper application
of hydrolysates during medium optimization may result
in decreased system performance and/or increased
system variability. This medium dependence will be
discussed, along with key elements of a suggested
hydrolysate screening protocol that will help ensure
effective evaluation of a supplementation scheme’s
overall contribution to system performance.
J.F. Babcock, Ph.D., Cell Culture Applications Manager,
Sheffield Bio-Science
8 www.IBCLifeSciences.com/BPI
11:45 Concurrent Technology Workshops
Room 550
Maximizing Protein
Expression in Suspension
CHO Cell Transient Transfection
Transient transfection allows researchers to bridge the
development bottleneck and shorten the time to usable
protein. CHO suspension cells are used for stable protein
expression, despite being refractory to commonly used
transfection methods (e.g. linear PEI). Mirus Bio has
developed a more effective alternative, the TransIT®-PRO
transfection reagent. Maximum transient expression
is achieved through optimization of cell density, DNA
concentration, quantity of transfection reagent, and
media formulation.
Laura Juckem, Ph.D., R&D Senior Scientist, Mirus Bio
12:15 Luncheon Presentation (Ballroom A)
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
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
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen, Inc.
9:15 CASE STUDY Creating a QbD Chromatography Design Space
Using Mechanistic Modeling Techniques
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
Martin Kane, Associate Director Process Statistics, Department of Biostatistics,
Human Genome Sciences, Inc.
10:45 What do you Need to Do to Fully Leverage Flexibility Inherent
in QbD
Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.;
former Senior Staff Fellow, OPS, CDER, US FDA
11:15 Audience Interactive Panel Discussion
Leveraging Flexibility in QbD
Moderator:
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
Panelists:
Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.;
former Senior Staff Fellow, OPS, CDER, US FDA
Martin Kane, Associate Director Process Statistics, Department of Biostatistics,
Human Genome Sciences, Inc.
Justin McCue, Ph.D., Principal Engineer, Downstream Process Development,
Biogen Idec
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc.
Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc.
Room 552
Efficient Packing of
Biochromatography
Media with Novasep Prochrom® Columns
Novasep's new high performance low to medium
pressure Prochrom® columns are made especially for
biochromatography. The combination of a moving piston
and valves with an automated packing unit makes their
design special and allows various modes of efficient,
effortless and fast "in place" packing. More particularly,
"flow packing" and "dynamic axial compression packing"
will be presented for a polymer-based media. Efficiency
measurements and scale-up strategies will also be
illustrated for these two packing modes.
Jin Seok Hur, Ph.D., R&D Manager, Novasep, Inc.
Jason Spacek, M.S., Biopharmaceuticals Business
Manager, Novasep, Inc.
A Novel Approach to Integrate the Purification Process for Monoclonal Antibodies that Increases Processing Productivity
As the demands and challenges associated with the purification of therapeutic proteins increase, new tools are needed. In this talk, the development of three
chromatography media to enable improved process flexibility in terms of plant fit and buffer requirements will be described. Efforts to develop a flexible three
step monoclonal antibody purification involving minimal buffer changes/dilution between process steps will be discussed. Optimization of a process using
Protein A affinity capture directly eluted onto a cation exchange column followed by elution and direct loading of an anion exchange membrane adsorber will be
used to describe the process flexibility benefits of these new purification tools.
Richard Pearce, Program Director - Purification Solutions, Millipore Corporation