TC Biopharm Scottish Facility Licensed for Cell Therapy Research

TC BioPharm Ltd’s clinical manufacturing facility in Scotland has been licensed for the production of human cell therapy products, a vital process in the fight against cancer. The Medicines Healthcare Products Regulatory Agency (MHRA) granted the license to the Maxim Park, facility at Eurocentral, following an extremely positive inspection by MHRA's inspectors.

The company’s technology, which uses patients’ own immune cells grown in culture to target cancer and major viral infections, has a safe history based on the treatment of numerous patients by strategic partner Medinet in Japan.

TCB also obtained scientific advice from the MHRA, which provided a clear roadmap to clinical studies. Under expert guidance from principal investigator, Professor Jeff Evans of the University of Glasgow, TCB plans to treat the first cohort of patients during 2015, working alongside established cancer clinics throughout Scotland.

The multi-million pound facility - which includes two independent GMP cleanrooms, process development laboratories and a quality control suite that allows in-house environmental monitoring, product testing and release; is set to become a hub for immuno-cell therapy research to benefit cancer patients in the UK and Europe. The complete build took just 12 weeks from start to finish, plus another 12 weeks to commission the facility and its equipment; implement a quality management system and ensure staff were suitably trained for subsequent manufacture of the clinical product.

Commenting on this success, Angela Scott, TCB’s operations director, said: “Advancing from an empty shell to MHRA approval of a GMP facility in less than six months is an unprecedented achievement. Such rapid progress is a glowing testimony to the dedication, experience, discipline and passion of our employees who made this possible.”

In addition to the pioneering use of immune cells to treat cancer, TCB plans to treat early-diagnosis HIV patients with its innovative treatment. Dr Michael Leek, chief executive at TCB added: “Investing substantial amounts of cash and manpower upfront to build this amazing, state-of-the-art cleanroom facility has paid dividends for TC BioPharm.  As we move our immunotherapy platform towards clinical studies in cancer, the MHRA license accelerates us to the forefront of UK cell therapy, representing a key commercial milestone, adding significant value for our investor-base as we progress during 2015.”

Commenting on TCB’s regulatory approval, Pamela Nash MP said: “This is great news and well deserved. Dr Leek and his team have worked tirelessly to ensure that this facility is of the highest standard.  Now TC BioPharm can get down to the important work of producing cell therapies which could transform many lives for the better.”