It is crucial for the long-term viability of cell and gene therapy development programs that early-phase researchers are aware of how the methods and materials they select can impact the program's future success, especially in terms of regulatory approval, cost, and timeframe.

With 40-50% of CGT programs that enter Phase III experiencing a disruption or hold, often due to CMC issues, it is essential that risks are minimized from the very beginning. 

This whitepaper explores considerations to balance the pursuit of scientific breakthrough with practical factors for establishing a robust manufacturing and regulatory approach that will be essential for program scaling and transition to the clinic.

Learn more about:

• Avoidable costs that can be incurred through decisions made during early development and discovery stages
• Key considerations and pitfalls to avoid when taking a CGT product from early-stage discovery to successful scale-up and regulatory approval
• The advantages of partnering with a CGT-specialized contract development and manufacturing organization (CDMO) early in the discovery stage