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Sarepta Viral Vector Gets FDA Platform Technology Designation
The rAAVrh74 viral vector is a key component in several of Sarepta’s gene therapy programs, including Elevidys, an already FDA-approved gene therapy for Duchenne muscular dystrophy. It is also ...
U.S. FDA Grants Platform Technology Designation to the Viral Vector Used in SRP-9003, Sarepta’s Investigational Gene Therapy for the Treatment of Limb Girdle Muscular Dystrophy Type 2E/R4 ...
(RTTNews) - Sarepta Therapeutics (SRPT), Wednesday announced that the FDA has designated its rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 for limb-girdle muscular ...
Viral vectors are vital for the cell and gene therapy industry. However, long production timelines, combined with quality and consistency issues, mean that growing demand is outstripping supply.
As for the Devens site where BMS plans to relocate viral vector production, the 700,000-square-foot plant handles both process development and commercial manufacturing. The FDA cleared a facility ...
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