Program Information - IBC Life Sciences

Cell Culture & Upstream
Processing (Room 552)
Chairperson: Susan Casnocha, Ph.D., Research
Fellow, Bioprocess R&D, Culture Process Development,
BioTherapeutics Pharmaceutical Sciences, Pfizer Inc
Integrating In-Line Process
Monitoring and Control Technologies
in Upstream Processing
10:30 Fully Automated Mammalian Cell
Culture via Multi-Functional Off-Line
Analyzer and Online Sampling System
Gayle Derfus, Engineer II, Oceanside Pharma
Technical Development, Genentech, Inc.
11:00 Achieving Process Robustness
through Process Analytical
Technology (PAT) Implementation
Li Malmberg, Ph.D., Director, Technical Operations,
Biologics Manufacturing, Abbott Laboratories
11:30 Understanding the Latest Automated
Online Analytics as a QbD Tool in
Fermentation Processes
Stefan Steigmiller, Ph.D., Senior Project Manager,
PAT, Bayer Technology Services GmbH, Germany
12:00 Concurrent Technology Workshops
12:30 Networking Lunch in Exhibit and Poster
Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their
posters for discussion.
Plenary Session
Critical Industry Issues
1:45 Chairperson's Remarks
Howard L. Levine, Ph.D., President,
BioProcess Technology Consultants, Inc.
2:00 Flexible Manufacturing for
a Diverse Biologics Portfolio
Phillip Gomez, Ph.D., Director,
PRTM Management Consultants
2:30 Patient-Driven Delivery
Devices: Is your Company
Playing to Win
James J. Collins, Jr., P.E., M.B.A.,
Vice President, Drug Delivery and
Device R&D, Eli Lilly and Company
3:00 Prevnar 13: The Story Behind
the Vaccine
Willard Waterfield, Ph.D., Senior Director,
Manufacturing Sciences & Technology, Andover
and Pearl River, Pfizer GMS
3:30 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
Plenary Keynote Presentations
(Ballroom A)
Chairperson: Wolfgang Noe, Ph.D., Vice President,
Bioprocess Development, Biogen Idec
4:00 Sustainable Commercial
Cell Culture Operations
W. Blair Okita, Ph.D.,
Senior Vice President, Manufacturing
Sciences and Technical Operations,
Genzyme Corporation
4:45 Finding a Home for Process
and Product Development
S. Robert Adamson, Ph.D., Advance
Biotech Consultants; former Senior
Vice President Product and Process
Development, Wyeth Biopharma
Wednesday, September 22, 2010 (continued)
Rapid Vaccine Development
and Production (Room 555B)
Process Development for Novel
Vaccines and Immunotherapeutics
10:30 CASE STUDY Process Development and
Clinical Manufacturing for Autologous
Dendritic Cell Immunotherapies
Tamara Monesmith, Director of Manufacturing
and Process Development, Argos Therapeutics
11:00 CASE STUDY Rapid Production of a
Novel VLP Vaccine
Richard M. Schwartz, Ph.D., Chief, Vaccine
Production Program Lab, Vaccine Research Center,
National Institutes of Health
11:30 CASE STUDY Rapid Analytical, Process
and Regulatory Strategies for Seasonal
and Pandemic Flu Vaccines
Robert Boulanger, Ph.D., Manager, Production,
Protein Sciences Corporation
Special Presentation
12:00 Defending Biosimilar Competition:
Bioprocess IP Protections for
Next Generation Vaccines and
Immunotherapeutics
George A. Xixis, Partner,
Nutter McClennen & Fish LLP
12:30 Networking Lunch in Exhibit and Poster
Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their
posters for discussion.
Process Development and Analytical
Characterization for Vaccine Production
1:55 Chairperson’s Remarks
Vincent Turula, Ph.D., MBA, Associate Research
Fellow, BioTherapeutics and Vaccines Outsourcing,
Pfizer, Inc.
2:00 CASE STUDY Analytical
Characterization for Conjugate
and Protein Vaccines
Vincent Turula, Ph.D., MBA, Associate Research
Fellow, BioTherapeutics and Vaccines Outsourcing,
Pfizer, Inc.
2:30 CASE STUDY Particle and Endotoxin
Control in Form/Fill Tubing Manifolds
for Vaccines
Michael Moussourakis, Technical Manager,
Pall Life Sciences
3:00 CASE STUDY Scale-up of an Intensified
Process for rAd35 Adenovirus Production
using the PER.C6® Cell Substrate
Ciska Dalm, Ph.D., Senior Scientist, Upstream
Process Development, Crucell, The Netherlands
3:30 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
Rapid Vaccine Development & Production
4:00 CASE STUDY Production and
Downstream Processing of Norovirus
Virus-Like Particles
Ross Taylor, Ph.D., Director, Process Development,
LigoCyte Pharmaceuticals, Inc.
4:30 From Bench to Bag: Deployment and
Implementation of Novel Solutions for
Vaccine Production
Andrew Clutterbuck, Purification Development
Team Leader, Eden Biodesign Ltd., United Kingdom
5:00 Vaccines Track Ends
5:30 Networking Cocktail Reception in Exhibit and Poster Hall Sponsored by
Formulation Strategies for
Protein Therapeutics
(Room 555A/556)
11:00 Analysis of Subvisible Particles by
Flow Microscopy
Rajesh Krishnamurthy, Ph.D., Director, Analytical
and Pharmaceutical Sciences, ImmunoGen, Inc.
11:30 CASE STUDY Investigation of
Therapeutic Protein Particle
Formation during Filling Operations
Shona C. Patel, Ph.D., Senior Development
Engineer, Merck Research Laboratories
12:00 Technology Workshop
Tm and Beyond! Combining
Equilibrium and Kinetic Stability
Data to Add a New Dimension to High
Throughput Formulation Development
The equilibrium thermal transition temperature, Tm,
of a protein is a widely used metric of protein physical
‘stability’ in the screening of candidate proteins and
formulations. This value may rapidly be obtained from
many samples whilst consuming very little protein
sample using recently available instrumentation.
However, the ‘equilibrium’ Tm represents only
part of the physical stability story, and the kinetic
(time dependant) behaviour of both unfolding and
aggregation may provide additional valuable insights to
guide candidate selection and formulation development.
This is discussed and example data is presented.
Simon Webster, Ph.D., Chief Scientific Officer,
Avacta Analytical Ltd., United Kingdom
12:30 Networking Lunch in Exhibit and Poster
Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their
posters for discussion.
1:55 Chairperson’s Remarks
Andrea Ji, Ph.D., Scientist, Genentech, Inc.
Evaluation and Control of
Biopharmaceutical Stability
2:00 CASE STUDY Mitigation of Oxidation
in Therapeutic Proteins
Andrea Ji, Ph.D., Scientist, Genentech, Inc.
2:30 CASE STUDY Formulation Development
of Therapeutic Antibodies using Highthroughput
Fluorescence and Static
Light Scattering Techniques: Role of
Conformational and Colloidal Stability
Sathish Hasige, Ph.D., Senior Scientist, Formulation
Sciences, Process Biochemistry, MedImmune, Inc.
3:00 CASE STUDY The Impact of Prefilled
Syringe Leachables on Protein Stability
Xiaofeng Lu, Ph.D., Senior Scientist, Facet Biotech
3:30 Networking Refreshment Break
in Exhibit and Poster Hall
Sponsored by
4:00 Low Volume, High-Throughput Thermal
Analysis of Proteins by Fluorescence Dye
Binding using a RT-PCR Instrument
Thomas Palm, Ph.D., Senior Research Investigator,
Pharmaceutics, Bristol-Myers Squibb Company
4:30 CASE STUDY The Importance of
Understanding the Physical State
of Excipients in a Freeze-Dried
Formulation: Implications for Overall
Product Quality
Juan Davagnino, Ph.D., Director, Biopharmaceutical
Development, KBI Biopharma, Inc.
5:00 CASE STUDY Effects of Surface
Tension and Excipient Binding on
the Conformational Stabilization of a
Monoclonal Antibody
Suzanne J. Hudak, Associate Scientist,
MedImmune, Inc.
5:30 Networking Cocktail Reception
in Exhibit and Poster Hall
Sponsored by
BioProcess International Conference & Exhibition 13