BLA Submission & PPQ Strategies: Navigating the Critical Path to Regulatory Approval
Time: 1:00 pm
day: Pre-Conference Day Track D PM
Details:
Gene therapy products present unique challenges in analytical development. This workshop will provide practical strategies for addressing key aspects of BLA submissions, including viral vector characterization, comparability studies, and PPQ. Attendees will gain insights into ensuring product consistency, regulatory compliance, and a smooth path to approval.
Key Discussion Points:
- Regulatory Requirements for BLA Submissions: Key analytical aspects for gene therapy products, including vector characterization and potency testing
- Comparability Studies for Gene Therapy: Strategies for designing studies to ensure consistency between clinical and commercial products
- PPQ Strategies for Analytical Methods: Best practices for validating assays and ensuring consistency across production scales
