Set Your Cell And Gene Therapy Program Up For Success From Day One
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Avoidable costs, pitfalls, and considerations for discovery and preclinical stages for long-term program success
Early decisions in cell and gene therapy (CGT) development can impact long-term viability. With 40-50% of CGT programs in Phase III facing disruptions, often due to CMC issues, minimizing risks from the start is crucial. This whitepaper discusses balancing scientific breakthroughs with practical manufacturing and regulatory strategies for successful scaling and clinical transition.
Learn more about:
- Estimated avoidable costs – both in terms of timeline and budget – that can be incurred through decisions made during CGT early development
- Key considerations for taking a CGT product from early-stage discovery to successful scale-up and regulatory approval
- Potential pitfalls that early-stage scientists must be aware of and how these can be avoided
- The advantages of partnering with a CGT-specialized contract development and manufacturing organization (CDMO) early in the discovery stage