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Biotech Opens Gene Therapy Manufacturing Facility

Adeno-associated virus

Adeno-associated virus diagram (Lawrence Berkeley National Lab)

23 July 2021. A biotechnology company serving gene therapy developers is opening a manufacturing facility for engineered viruses that deliver gene therapies. Capsida Biotherapeutics Inc. is opening the production labs and plant in Thousand Oaks, California, near the company headquarters in Newbury Park.

Capsida Biotherapeutics, a two year-old enterprise, creates engineered adeno-associated viruses to deliver gene therapies. Adeno-associated viruses or AAVs are benign, naturally occurring microbes that infect cells, but do not integrate with the cell’s genome or cause disease, and generate at most a mild immune response. Capsida says it modifies AAV capsids to reduce adverse events from gene therapies with better targeting that limits off-target effects and also makes possible lower treatment doses. Capsids are protein shells that carry, protect, and deliver viral genomes.

Much of the company’s work is devoted to gene therapies for inherited central nervous system disorders. As reported by Science & Enterprise in June, Capsida and Crispr Therapeutics are collaborating on design of gene therapies for treating familial amyotrophic lateral sclerosis, or ALS, and Friedreich’s ataxia, both inherited diseases. The collaboration aims to create and produce gene therapies for in vivo therapies — those that work inside the body — using the gene-editing technique Crispr.

Meeting GMP standards

Capsida says its new 15,000-square-foot manufacturing facility that meets good manufacturing practice or GMP standards will have two production suites, a fill suite, and quality-control labs. The plant expects to employ single-use equipment when possible, to enable quick changeovers for manufacturing subsequent products, and use unidirectional flow to increase environmental control. The company anticipates 40 to 50 people working at the plant.

“One of our key strategic priorities at Capsida is to create therapies that can be manufactured consistently and rapidly while maintaining the highest quality,” says Rayne Waller, Capsida’s chief manufacturing officer in a company statement. Our new manufacturing facility eliminates the dependence on contract manufacturing which will allow us to bring products seamlessly from discovery into clinical studies faster.”

Rob Murphy, vice president of manufacturing at Capsida adds, “The faster we are able to produce clinical supplies, the faster we’ll be able to get our innovative gene therapies to the patients who need them. ”

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