Now in its 12th year, IBC’s Well Characterized Biologicals continues its tradition of delivering the latest analytical approaches and technologies to help you better understand and overcome the significant challenges of protein characterization. Benefiting from a long-standing partnership with industry leaders and regulatory experts, IBC has developed a comprehensive program of proven approaches that provides a roadmap to successfully navigate the ever-changing regulatory landscape. Do not miss this opportunity to share successful strategies and best practices with fellow scientists and regulatory officials to help you optimize product and process knowledge.

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