- Biopharma News
TCR2 bets on lead candidate with new cell therapy manufacturing facility30 Mar 2021
The US facility in Rockville is expected to accelerate the company’s commercial-scale manufacturing timelines of gavo-cel
Clinical stage cell therapy company TCR2 Therapeutics has signed a long-term, full-building lease for an existing 85,000-sq. ft manufacturing facility in Rockville, Maryland, which is ready for Current Good Manufacturing Practice (cGMP) build-out.
The site will support clinical and commercial production of gavo-cel — the company's lead TRuC-T cell product — with a capacity to treat several thousand cancer patients annually.
Gavo-cel is currently in a Phase I/II clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma.
TCR2 said leasing an existing manufacturing facility would save the company time and capital, and would help to accelerate the company’s commercial-scale manufacturing timelines with production anticipated in 2023.
According to TCR2 Therapeutics' President and CEO, Garry Menzel, the company was keen to secure a "dedicated US manufacturing facility" having been encouraged by "consistent early clinical benefit and manageable safety profile" experienced by patients treated with gavo-cel.
The new facility will allow the company to directly leverage its cell therapy process development expertise and control its end-to-end production supply chain. Upon completion, It will provide space for commercial and clinical manufacturing, quality control laboratories and offices.
TCR2 is designing the cell therapy facility to utilize semi-automated and functionally closed systems which aim to provide cGMP manufacturing and, simultaneously, optimize the reliability of its cell therapy products, and reduce manufacturing costs and vein-to-vein time. The flexible layout will allow production of gavo-cel and other emerging cell therapies in the TRuC-T cell pipeline.
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