Institute for International Research

Keynote Presentation The Biosimilar Dilemma - A Global Perspective Robert L. Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc. Featured Presentation The 2008 Baxter Heparin Recall - A Case Study of Detection, Contaminant Characterization, and Product Remediation Edward K. Chess, Ph.D., Senior Director, Physical and Chemical Sciences, Technology Resources, Baxter Healthcare Corporation Regulatory Keynote Address Using Quality by Design (QbD) for Biotechnology Products - What are the Unique Considerations and How can QbD Enhance the Development of Biotechnology Products? Steven Kozlowski, Ph.D., CDER, US FDA Featured Regulatory Presentations Characterization of Oversulfated Chondroitin Sulfate in Heparin and its Association with Adverse Clinical Events Ali Al-Hakim, Ph.D., CDER, US FDA FDA's Perspective on Demonstrating Comparability for Biosimilar Products Emily Shacter, Ph.D., CDER, US FDA An FDA Perspective on the Development of Appropriate Potency Assays for Biopharmaceutical Products Carla S. Lankford, M.D., Ph.D., CDER, US FDA Product and Process-Related Impurities and their Impact on Product Quality - An FDA Perspective and Recommendations Barbara Rellahan, Ph.D., CDER, US FDA Necessity of Change for Plasma and Recombinant Products Roman T. Drews, Ph.D., CBER, US FDA

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.

12 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
• Demonstrating comparability for biosimilar products
• Host cell protein assays
• Product and process-related impurities and their impact on product quality
• The development of appropriate potency assays for biopharmaceutical products
• Using Quality by Design (QbD) to enhance development of biotechnology Products
• Necessity of change for plasma and recombinant products