Navigating Characterization Strategies in Cell Therapy Development with Evolving Insights from FDA Guidance
Time: 11:00 am
day: Workshop C - Analytical Development
Details:
In the rapidly advancing field of cell therapy, developers face significant challenges in characterizing their products to meet regulatory standards. The FDA has provided evolving guidance on what is required for effective characterization, which includes understanding product attributes, ensuring consistency, and demonstrating safety and efficacy.
Join us to:
- Understand how cell therapy developers are adapting their characterization strategies in response to evolving regulatory requirements, identifying areas for innovation and improvement in current practices.
- Delve into recent FDA guidance on cell therapy characterization, exploring strategies for effectively interpreting and implementing these expectations.
- Discuss approaches for aligning characterization strategies with FDA expectations to ensure compliance and facilitate regulatory approval.
