Well Characterized Biologic & Biological Assays is a conference that covers topics such as:
- 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
Well Characterized Biologic & Biological Assays brings together 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