Achilles Therapeutics expands manufacturing in the UK
The scale up in annual capacity and expansion of Achilles’ global clinical manufacturing footprint will see its second site in the UK and first site to be established in the US.
Achilles Therapeutics has announced its clinical manufacturing expansion in the United Kingdom and the United States.
Achilles’ manufacturing facility at the Cell & Gene Therapy Catapult (Catapult) in Stevenage, UK, has received a manufacturing license from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and, separately, the company has entered into a partnership agreement for clinical manufacturing with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organisation in King of Prussia, Pennsylvania. The additional peak annual capacity of up to 600 doses of the company’s personalised clonal neoantigen-reactive T cell product candidates, known as cNeT, will support clinical manufacturing in the two ongoing Phase I/IIa CHIRON and THETIS clinical trials in advanced non-small cell lung cancer and recurrent or metastatic melanoma, respectively.
“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,” commented Edward Samuel, Executive Vice President of Technical Operations at Achilles Therapeutics.
Following the receipt of a manufacturing license from the MHRA, the Catapult facility is now GMP certified to produce clinical grade doses of cNeT. This second GMP manufacturing site at the Catapult will initially support Achilles’ proprietary VELOS manufacturing process with an annual capacity of 200 cNeT doses at peak production. The company’s first US GMP manufacturing facility to be operated by CBM in King of Prussia, Pennsylvania will have an initial annual capacity of 150-200 doses at peak production.