Streamlining Licensed Gene Therapy Integration: Abeona Therapeutics’ Approach to CMC Adaptations & Regulatory Success
Time: 2:45 pm
day: Day 1 - Manufacturing 2
Details:
- Explore Abeona’s strategies for modifying the CMC aspects of a licensed gene therapy to align with their proprietary manufacturing practices, ensuring consistency and efficiency
- Gain insights into Abeona’s approach to maintaining therapeutic integrity while implementing necessary process adjustments, including raw material sourcing, quality testing, and scalability
- Understand the regulatory landscape for manufacturing-modified licensed therapies, with lessons from Abeona’s experiences in compliance, submission requirements, and securing timely approvals
