October 25-28, 2021
Delivered in a 100% Digital Format
THE LEADING EVENT TO ENSURE CMC, REGULATORY SUCCESS AND EXPEDITED PRODUCT APPROVAL
Gain Practical Advice From Case Studies, FDA & Regulatory Leaders to Accelerate Your Biologics & Novel Modalities/Molecules to Market
Get the latest event updates
FDA Speakers Confirmed to Speak at WCB 2021 Virtual Event
Hear Directly from FDA Regulators & Industry Experts to Avoid Pitfalls on the Path to Approval
Accelerate your product timelines and overcome development and submission challenges
Well Characterized Biologics Topics
- Accelerating Analytics, Characterization and Bioassay Development?
- Analytical and Biophysical Characterization Requirements for Novel Modalities
- Analytical Techniques, Platforms and Strategies for Cell & Gene Therapies
- Efficient Stability Monitoring of Drug Product
- Next Generation Characterization Methods using NGS and NMR
Biological Assays Topics
- Analytical Challenges with Potency Assays and Comparability for Cell & Gene Therapy Products
- New Characterization Methods for HCPs
- Comparability Protocols when Switching Critical Reagents
- Lifecycle Management and Validation of Bioassays
- Cell-based Assay strategies for Novel Modalities
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