Gene Therapy for Rare Disorders
March 20-23, 2023
FUJIFILM Diosynth Biotecnologies is excited to be attending and presenting at Gene Therapy for Rare Disorders, March 20-23, 2023 in Boston, MA. Stop by booth 16 to meet our team to learn more about FUJIFILM Diosynth Biotechnologies’ capabilities and how we can help you advance and deliver tomorrow’s medicines.
Join Us March 21st @ 11:45 am
Samantha Hullah, PhD, is Head of Process Development at FUJIFILM Diosynth Biotechnologies, Watertown, MA will present 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