Event: Biogen Symposium
Date: October 2nd
Location: Biogen in Cambridge, MA

Abstract:
The development of innovative advanced therapies represents a great opportunity to dramatically improve patients’ lives. However, the rapid and efficient production of these advanced therapies remains a considerable challenge. In this poster, we discuss downstream development challenges and our recent technological advancements in the process development of viral vector manufacturing. From clarification to separation of empty and full capsids, each downstream processing step has its challenges in viral vector manufacturing at a CDMO. As we continue to make progress for AAV, a series of programs were implemented to advance our scalable large scale manufacturing AAV viral vector platform.

Key Takeaways:

  1. Downstream processing has challenges with GOI and serotype differences.
  2. New approaches are available but untested at large scale for AAV
  3. Suspension platform for viral vectors with HEK293 cells are in progress.
  4. Work to establish producer cell line are in progress.
  5. An analytical platform has been developed to support AAV viral vectors.