BioCentury
ARTICLE | Product Development

Creating drug master files for AAV vectors

FDA, NIH leaders want to help the business case for ultra-rare disease gene therapies. FNIH’s Bespoke Gene Therapy Consortium is the vehicle

November 29, 2021 9:26 PM UTC

FNIH has a vision for scaling gene therapy development that involves creating master files for viral vectors that can smooth the regulatory path and improve reproducibility. The hope, among FDA and ...





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