Well Characterized Biologicals
Venue: Hyatt Regency Reston
Location: Reston, Virginia, United States
Event Date/Time: Nov 10, 2008 | End Date/Time: Nov 12, 2008 |
Description
10 Industry Case Studies Including:
• 2008 Baxter Heparin recall – The manufacturer’s perspective on the detection, contaminant characterization, and product remediation
• Comparison of purported erythropoietin products from Asia and Latin America with innovator product Epoetin Alfa
• Characterization and testing strategies for problematic host cell protein
• Opalescence in antibody formulations – a clarifying case study of a critical phenomenon
• Phased approach to selecting and developing a suitable potency assay
• Characterization of human IgG2 disulfide isoforms
FDA Perspectives on Critical Issues Including:
• Characterization of oversulfated chondroitin sulfate in Heparin and its association with adverse clinical events
• Comparability requirements for legacy products
• Demonstrating comparability for biosimilar products
• Implications of host cell protein levels and their impact on product quality – perspectives and considerations given the experience with product safety and comparability
• Assessing risk of new impurities for well characterized biologicals
• Bioassay expectations & strategies