Charles River Laboratories International, Inc. and ASC Therapeutics announced they have agreed to manufacture ASC618, a second-generation gene therapy for hemophilia A.
Hemophilia A is caused by the lack of the blood clotting factor VIII (FVIII), a protein whose instructions are provided by F8, a gene that is mutated in people with the disease. ASC618 is designed to deliver a shortened, but optimized version of the gene to liver cells. ASC Therapeutics has received IND clearance, as well as key regulatory designations in the U.S. and Europe for its ASC618 program.
Viral Vector Manufacturing Services
Since 2019, ASC Therapeutics has worked with Charles River, previously Vigene Biosciences, to leverage the Company’s industry-leading expertise in Good Manufacturing Practice (GMP)-virus manufacturing, and established processes for AAV production and purification. Together, Charles River and ASC Therapeutics have established a high-yield upstream process for AAV8 production, optimized the downstream purification methods to result in a more predictable drug product output, and fine-tuned a scalable manufacturing process in both upstream and downstream.
The collaboration will take advantage of Charles River’s end-to-end CDMO capabilities, building on the Company’s acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences in 2021 that expanded its comprehensive cell and gene therapy portfolio to span each of the major CDMO platforms – cell therapy, viral vector and plasmid DNA production.
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