BPD Cell and Gene Therapy Symposium & Vendor Show
April 12, 2023
Chapel Hill, NC
FUJIFILM Diosynth Biotechnologies is excited to be presenting at BPD’s 4th Cell and Gene Therapy Symposium and Vendor Show, Wednesday, April 12, 2023, at the UNC Friday Conference Center in Chapel Hill, NC.
Samantha Hullah, Ph.D., Head of Process Dev, FUJIFILM Diosynth Biotechnologies, Watertown, Ma will be presenting at 3:55 pm, April 12th on Early Stage Considerations for the Development of Gene Therapies for Rare Diseases
Therapeutic and curative focused therapies for rare diseases can be given accelerated pathways to INDs and BLAs to deliver much needed therapies to patients rapidly. Expediting critical path activities to translate these therapeutics from the lab into robust manufacturing processes for clinical and commercial supply is not without challenges. FUJIFILM Diosynth Biotechnologies provides a flexible AAV development and manufacturing platform that can help our partners navigate these challenges by streamlining the critical path from pre-clinical and clinical development through commercialization.
This presentation will focus on key considerations for early stage process development and the pathway to cGMP manufacturing.
Attendees will gain insight on:
- How to ensure the best start with your CDMO
- What the critical steps are in process and analytical development
- FDB’s AAV Platform Approach
- Assuring reproducibility and quality products for FIH clinical trials
- Scaling up for subsequent phases and commercial production