2011 Program Co-Chairs

Jeri Ann Boose, PhD
Director, Biopharmaceutical Services
Lancaster Laboratories Inc.
Raymond Nims, PhD
Consultant
RMC Pharmaceutical Solutions, Inc.
TOPICS:
» Cell Line Development and Banking » Media and Assay Development
» Expression Optimization » Clarification and Purification
» Feed and Harvest Strategies » Characterization and Comparability
» Conjugation and Formulation » Regulatory Compliance
» Process Automation and Documentation  

2011 Program Schedule

  Sunday, April 3, 2011

4:00 pm–7:00 pm Welcome Reception (Half Moone)

  Monday, April 4, 2011

7:00 am–8:00 am Registration and Continental Breakfast (Nauticus, 3rd Floor)

8:00 am–8:30 am Meeting Overview (Nauticus, 3rd Floor) & Exhibit Setup (Half Moone)

8:30 am–10:00 am Plenary – Contaminant Detection and Prevention (Nauticus, 3rd Floor)
& Exhibit Setup (Half Moone)

10:00 am–10:30 am Morning Break (Half Moone)

10:30 am–11:15 am Robert J. Duff, PhD Protein Glycosylation and Analytical Methods for Glycan Characterization for Biopharmaceuticals: An Overview
Manager, Biochemistry
Lancaster Laboratories Inc.

11:15 am–12:00 pm Raymond Nims, PhD Adventitious Viral Contamination of
Biopharmaceuticals: Who is at Risk?
Consultant
RMC Pharmaceutical Solutions, Inc.

12:00 pm–1:30 pm Lunch (Half Moone) and Poster Presentations from 1:00 pm-1:30 pm (Half Moone)

1:30 pm–2:15 pm Katrina M. Nolan, PhD Examining the Supply Chain for Biopharmaceuticals – Testing Programs to Avoid Virus Contamination Issues
Senior Scientist, Virology
WuXi AppTec Inc.

2:15 pm–3:00 pm Martin Wisher, PhD Contaminant Detection in Biologicals: Limitations
of Existing Assays and Potential of New Methods
Senior Director,
Scientific and Regulatory Affairs
BioReliance, Ltd.

3:00 pm–3:30 pm Afternoon Break (Half Moone)

3:30 pm–4:15 pm Wendy P. Osheroff, PhD Virus Safety Risk Assessment: A Case Study in Virus
Safety Risk Reduction in a Multi-Product Facility
Section Head - Pathogen Safety
Support and Compliance
Talecris Biotherapeutics

4:15 pm–5:00 pm Frederick S. Larimore, PhD Process Control Strategy Development for Biotech Products
Principal Consultant
Sierra Vista Biotech Consulting

5:00 pm–5:45 pm Keynote Address – US Government Strategies for Medical Countermeasures
and Pandemic Influenza Vaccines
(Half Moone)
Robin A. Robinson, PhD
Director & Deputy Assistant Secretary
BARDA/ASPR/HHS

5:45 pm–8:00 pm Pirates of Hampton Roads Reception (Half Moone)

  Tuesday, April 5, 2011

7:30 am–8:30 am Continental Breakfast (Half Moone)

8:30 am–9:15 am Jon S. Kauffman, PhD Analytical Strategies for Monitoring Impurities
Encountered in Bioprocessing
Director, Method Development & Validation
and Biopharmaceutical Services
Lancaster Laboratories Inc.

9:15 am–10:00 am Kristen L. Koterba, PhD Molecular Mechanisms of Antibody Disulfide Bond Reduction in CHO Cell Culture Processes
Post-Doctoral Research Fellow,
Late Stage Cell Culture
Genentech, Inc.

10:00 am–10:30 am Morning Break (Half Moone)

10:30 am–12:00 pm Technology Workshops (Half Moone)

12:00 pm–1:30 pm Lunch (Half Moone) and Poster Presentations from 1:00 pm-1:30 pm (Half Moone)
plus Baculovirus Reference Material Meeting (By Invitation)

1:30 pm–5:00 pm Special Sessions on Flexible Facilities and Systems,
plus Presentations in the Baculovirus Expression Track.
(Half Moone)

6:00 pm–9:00 pm Jazz Banquet at Scotty Quixx

  Wednesday, April 6, 2011

7:30 am–8:30 am Continental Breakfast (Half Moone)

8:30 am–9:15 am Alfred Luitjens Flexible Facilities With Single-Use Systems for
Primary Unit Operations in MAb Production
Senior Scientist New Technology
Crucell Holland BV
Parrish Galliher
Founder and Chief Technology Officer
Xcellerex, Inc.

9:15 am–10:00 am Jeri Ann Boose, PhD Current Topics in Viral Clearance: Virus Stock
Characterization and Definition of Design Space
Using Quality by Design Principles
Director, Biopharmaceutical Services
Lancaster Laboratories Inc.

10:00 am–10:30 am Morning Break (Half Moone)

10:30 am–11:15 am Damon R. Asher, PhD Spike Right: Ultrapure Virus
Preparations for Virus Filter Validation
Senior Scientist, Bioprocess R&D Virology
EMD Millipore

11:15 am–12:00 pm JoAnn Hotta, PhD Impact of Virus Spike Preparation on Viral
Clearance Studies for a Plasma Derived Protein
Research Fellow
Talecris Biotherapeutics

12:00 pm–1:30 pm Lunch (Half Moone) and Poster Presentations from 1:00 pm-1:30 pm (Half Moone)

1:30 pm–2:15 pm Natasha Prokhorenko Demonstration of Step Performance Reproducibility
Using an In-House Viral Validation Database
Bioprocess Engineer
Human Genome Sciences, Inc.

2:15 pm–3:00 pm M. Ellen Dahlgren Using a Statistical Design of Experiments (DOE) Approach to Define Ranges for Operating Parameters in Chromatography Steps of a Monoclonal Antibody Purification Process
Chromatography Unit Operations Expert

3:00 pm–3:30 pm Afternoon Break (Half Moone)

3:30 pm–5:00 pm Plenary – Contamination Detection and Prevention – Discussion and Wrap-Up
(Nauticus, 3rd Floor)
& Exhibit Teardown (Half Moone)