Applied Statistics
Characterization and Comparability for Complex Biological Products
Four Seasons Hotel,
Four Seasons Hotel98 San Jacinto Blvd.
Austin, TX
• Analytical Bridging Between Phases
• Functional Assays to Determine Effect of Biochemical / Biophysical Changes
• Product Comparability Assessments
• In-Process Monitoring
• Product Characterization Precedence
• Process Change Implementation
• Clinical Validation
• Rapid Analysis and Screening
• Documentation and Regulatory Submissions
• Trends in Biological Comparability
• Unique Challenges with Cellular and Viral Products
• Risk Assessment and Management

Schedule of Presentations:

Thursday, November 1, 2007
07:00:00 Registration, Continental Breakfast - Meeting Room Foyer
08:00:00 Introduction
08:30:00 Monitoring Varicella Manufacturing Process Using a Flow Symmetry Assay Jorge Vázquez
09:15:00 Characterization of Autologous Cell Therapy Products for Cartilage Repair Stephen Duguay
10:00:00 Break - Meeting Room Foyer
10:30:00 Product Comparability Testing: Current Methods and Future Concern Jeanne Novak
11:15:00 Characterizations of Whole Cell Cancer Immunotherapy in Late Stage Development Gautam Banik
12:00:00 Lunch and Poster Session - Meeting Room Foyer
13:30:00 Designer Displacers for the Purification and Trace Substance Enrichment by RP Displacement Chromatography: A Case Study of Early, Late, and Co-displacing Peptide Impurities Barry Haymore
14:15:00 Using SPR Sensor Technology to Improve Bio-Therapeutic Development and Quality Control Fredrik Sundberg
15:00:00 Break - Meeting Room Foyer
15:30:00 Complex Biological Products Enabled by Fabrication Processes from the Electronics Industry Joseph DeSimone
16:15:00 Characterization & Comparability of a Recombinant HPV Vaccine Michael W. Washabaugh
Friday, November 2, 2007
07:30:00 Breakfast - Meeting Room Foyer
08:30:00 Intellectual Property and Complex Biological Products - Creating Opportunities and Minimizing Risks Dale Hunt
09:15:00 Deveof a Surrogate Assay System for Bispecific Therapeutic Antibodies Irena Kirman
10:00:00 Break - Meeting Room Foyer
10:30:00 am Advanced Analytical Tools for Characterizing and Comparing Biopharmaceutical Proteins Steven Cohen
11:15:00 Panel Discussion
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