From Early Developability Assessment to Process Development and Scale-up of AAV Manufacturing with Novel Capsids and Payloads to 1000L Scale and Beyond
Time: 2:00 pm
day: Day 2- Manufacturing 2
Details:
- Best practices for integrating new methodologies into clinical trials and regulatory submissions
- How to work with regulatory agencies to gain approval for novel approaches
- Examples of successful implementation of innovative methods in gene therapy trials
