Myrtelle launches commercial manufacturing for Canavan disease gene therapy
Summary
Myrtelle has started commercial-stage manufacturing for MYR-101, its gene therapy for Canavan disease. The company is working with Charles River and Viralgen to build GMP manufacturing capacity for plasmids and vectors. Myrtelle says it is preparing regulatory filings and aiming for a commercial launch pending approvals. The FDA has also placed MYR-101 into its START pilot program, which gives the program added guidance and collaboration support.
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