Roundtable Discussion: Understanding Essential Assays for Gene Therapy Drug Approval – What You Need & Why
Time: 11:20 am
day: Day One
Details:
In this roundtable, you will gain practical insights into developing and implementing critical assays like potency, identity, and purity for gene therapy drug products, ensuring quality and safety. You will also learn how to align assay development with evolving regulatory requirements, enhancing product consistency and ensuring compliance throughout the product lifecycle.
- Understanding Key Assays for Gene Therapy: Explore the essential assays needed for the development of gene therapy drug products (DP), including potency, identity, and purity assays, and why each is critical for ensuring product quality and safety
- Assay Development & Implementation: Dive into the best practices for developing and implementing these assays, from early-phase exploratory work to late-stage, commercial-ready methods
- Regulatory Alignment & Strategy: Discuss how to align assay development with evolving regulatory requirements, ensuring assays meet both scientific and compliance standards throughout the product lifecycle
