Institute for International Research

IBC's Well Characterized Biologicals conference is the #1 forum for hearing industry case studies and unpublished new data on the challenges, strategies and technologies involved in protein characterization. Register now for exclusive access to meet FDA reviewers and industry experts who will share their insights to help you implement new approaches and avoid common pitfalls in your own characterization projects.

By attending you will:

• Hear first-hand from FDA reviewers about their "pet peeves" and suggestions to help you improve your IND Packages and characterization efforts
• Find new strategies to help you characterize complex protein products including enzymes, conjugates, vaccines and fusions
• Gain insights into the development of new biological assays for product characterization that you can benchmark against your own analytical testing efforts
• Discover new testing and characterization methods for host cell impurities and post-translational modifications that you can apply in your own lab
• Learn new techniques for monitoring protein aggregation and particulate formation to better characterize your own products
• Optimize your process and product knowledge through case studies on comparability and linking structure/function to critical quality attributes

Featured Regulatory Presentations

Characterization of Biotechnology Products: An FDA Perspective
Laurie Graham, CDER, US FDA

Analytical Characterization for Gene Therapy Products
Michael Havert, Ph.D., Biologist, Division of Cell and Gene Therapies, CBER US FDA

A Regulatory Perspective on the Development and Validation of Biopharmaceutical Potency Assays
Carla S.R. Lankford, M.D., Ph.D., CDER, US FDA

Strategies in the Design of Potency Assays for Therapeutic Enzymes
Richard Ledwidge, Ph.D., CDER, US FDA

Combination Products: An Overview
Kathy Lee, CDER, US FDA

Comparability of Biotechnology Products: Regulatory Considerations and Case Studies
Rashmi Rawat, Ph.D., CDER, US FDA

Joint Presentation: Pet Peeves and Roadblocks in CMC: Improving your Quality Submissions through the Product Lifecycle
Chana Fuchs, Ph.D., CDER, US FDA Marjorie Shapiro, Ph.D., CDER, US FDA