Well Characterized Biologic & Biological Assays

Topics

• Biological Assays Track
  • Lifecycle Management of Bioassays and Assay Changes to Commercial Products
  • QbD and DoE Approaches to Bioassay Development
  • Bioassay Development for Biosimilars and Complex Molecules
  • CMC Biological Assay Case Studies
  • Potency Assays: Automation, Statistics & Critical Reagents
  • Method Bridging and Method Tech Transfer for Bioassays
  • Regulatory Perspectives on Method Lifecycle Development for Bioassays
• Well Characterized Biologicals Track
  • Analytical Characterization Strategies for ADCs, Bispecifics, and Fusion Proteins
  • Regulatory Perspectives on Common Pitfalls in Your Analytical and CMC Studies
  • Biosimilar Characterization and Comparability
  • Case Studies of Protein Characterization and Product Comparability
  • Strategies for Higher Order Structure
  • Analytical Methods for Identification and Quantification of Host Cell Proteins
  • Strategies for Stability Studies for Diverse Products
  • Methods for Identifying, Monitoring and Controlling Product and Process Variants and Impurities

Who should Attend

Attendees with responsibilities in:

• CMC
• Analytical R&D
• Biological Assays
• Protein Analytical Chemistry
• Regulatory Affairs and QA/QC
• Bioassay Development and Innovation
• Product Development
• Process Development
• Drug Product Manufacturing
• Technical Operations/Manufacturing Sciences
• Bioanalytics
• Clinical Supply Chain Procurement
• Statistics
• Biological Development and Technologies
• Characterization