At TCR2 Therapeutics, a biotechnology company headquartered in Cambridge, MA, leaders keep working toward more independent bioprocessing. Recently, the company leased an 85,000 square foot facility in Rockville, MD, in preparation for producing its lead product, gavo-cel, which is in a Phase I/II clinical trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma.
CSO Robert Hofmeister, PhD, and his colleagues plan to turn this building into a clinical and commercial facility that they hope will provide treatments for several thousand patients a year by 2023.
TCR2 Therapeutics develops T-cell therapies for cancer based on its T-cell receptor (TCR) Fusion Construct T cells (TRuC-T cells). This technology offers several benefits, including HLA-independence similar to CAR-T therapies, enhanced tumor infiltration, and a lower release of cytokines, according to Hofmeister.
“We engineer a T-cell therapy that uses the entire TCR, and this way all of the subunits play together like people in an orchestra,” he explains.
To develop these therapies, Hofmeister and his colleagues started by teaming up with a CRO, then leased a clean room and established a manufacturing team in the U.K., and worked up to building out their own facility. All along, the TCR2 team planned on developing a semi-automated and closed system to produce its products. That’s just what the company will utilize in its manufacturing facility.
“The sooner that you adapt a certain process the better,” continues Hofmeister. Starting down a regulatory path with a known method, for example, reduces the need to change directions along the way. “That makes it easier to the extent that we limit our discussions with regulatory agencies,” he adds.
A semi-automated and closed approach also adds flexibility to the company’s bioprocessing. “We can switch from one product to another,” Hofmeister says. “With autologous cell products, making a new product for every patient in your clinical trials, you can’t scale up, but you can scale out.”