Sue Duan

Company: Astellas Pharma

Job title: Head of Analytical Developmen

Seminars:

BLA Submission & PPQ Strategies: Navigating the Critical Path to Regulatory Approval 1:00 pm

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…Read more

day: Pre-Conference Day Track D PM