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Achilles Therapeutics has announced that it will expand its clinical manufacturing capabilities in the UK and enter a partnership agreement for expansion in the US.
Achilles Therapeutics, a clinical-stage biopharmaceutical company, announced on April 12, 2022 that it is expanding its clinical manufacturing capabilities in the United Kingdom and the United States. The company’s manufacturing facility in Stevenage, UK, has received a manufacturing license from the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as entered into a partnership agreement for clinical manufacturing with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) based in Pennsylvania.
Following the receipt of the manufacturing license from the MHRA, the Stevenage facility is now good manufacturing practice (GMP) certified to produce clinical-grade doses of cNeT, the company’s personalized clonal neoantigen-reactive T cell product candidates. This facility will have an annual capacity of 200 cNeT doses at peak production. The company’s first US GMP manufacturing facility will be operated by CBM in King of Prussia, Pennsylvania, and will have an initial annual capacity of 150–200 doses at peak production.
“This significant scale up in annual capacity and expansion of our global clinical manufacturing footprint, with our second site in the UK and our first site to be established in the US, significantly strengthens our global clinical, technical, and supply chain operations,” said Edward Samuel, executive vice president of Technical Operations at Achilles Therapeutics, in a press release.
Source: Achilles Therapeutics