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
Avoid Common Pitfalls on the Path to Approval
Learn how to apply today's leading strategies to ensure CMC, regulatory success and expedited product approval directly from leading FDA regulators & industry experts.
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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
Connect With Today's Leading Regulatory, CMC and Bioassay Scientists
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us as an event sponsor or exhibitor to reach your goals.
Brian Peterson, MSc.
President, Analytical Consulting
Bioassay Solutions LLC
“The Well Characterized Biologics and Biological Assays conference has a long history of attracting scientists and regulatory professionals with a profound interest in developing best practices for analytical strategies. The opportunities to attend talks, focused short courses, and networking sessions, are second only to the experience of discussion and debate with the highest caliber of professionals in the Industry.”