{"id":45000,"date":"2022-06-13T14:01:42","date_gmt":"2022-06-13T12:01:42","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/charles-river-and-asc-therapeutics-to-scale-manufacturing-of-second-generation-gene-therapy-for-hemophilia-a\/"},"modified":"2022-06-13T14:01:42","modified_gmt":"2022-06-13T12:01:42","slug":"charles-river-and-asc-therapeutics-to-scale-manufacturing-of-second-generation-gene-therapy-for-hemophilia-a","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/charles-river-and-asc-therapeutics-to-scale-manufacturing-of-second-generation-gene-therapy-for-hemophilia-a\/","title":{"rendered":"Charles River and ASC Therapeutics to Scale Manufacturing of Second-Generation Gene Therapy for Hemophilia A"},"content":{"rendered":"
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\nExpanded relationship will build upon established processes initiated in 2019 to meet ASC Therapeutics clinical program<\/i>\n<\/p>\n

WILMINGTON, Mass.–(BUSINESS WIRE)–$CRL<\/a> #LIFEatCRL<\/a>–Charles River Laboratories International, Inc. (NYSE: CRL) and ASC Therapeutics, a privately held biopharmaceutical company pioneering the development of transformative in vivo<\/i> gene replacement, gene editing and allogeneic cell therapies, today announced they have agreed to manufacture ASC618, a second-generation gene therapy for hemophilia A.\n<\/p>\n

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\nHemophilia 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<\/a>, as well as key regulatory designations<\/a> in the U.S. and Europe for its ASC618 program.\n<\/p>\n

\nViral Vector Manufacturing Services<\/b>\n<\/p>\n

\nSince 2019, ASC Therapeutics has worked with Charles River, previously Vigene Biosciences, to leverage the Company\u2019s 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.\n<\/p>\n

\nThe collaboration will take advantage of Charles River\u2019s end-to-end CDMO capabilities, building on the Company\u2019s 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 \u2013 cell therapy, viral vector and plasmid DNA production.\n<\/p>\n

\nApproved Quotes<\/b>\n<\/p>\n