Eurocentral-based biotechnology company TC BioPharm Ltd (TCB) has been licensed for the production of human cell therapy products, hailed ‘a vital process in the fight against cancer’.
The Medicines Healthcare Products Regulatory Agency (MHRA) granted the licence to the Maxim Park facility, following ‘an extremely positive’ inspection by MHRA’s inspectors.
TCB’s technology uses patients’ own immune cells grown in culture to target cancer and major viral infections.
The company plans to treat the first cohort of patients during 2015, working alongside established cancer clinics throughout Scotland.
In addition to the pioneering use of immune cells to treat cancer, TCB plans to treat early-diagnosis HIV patients with its innovative treatment.
The multi-million pound facility is set to become a hub for immuno-cell therapy research to benefit cancer patients in the UK and Europe.
Dr Michael Leek, TCB chief executive, said: “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.”
Convenor of Regeneration in North Lanarkshire Council, David Fagan, added: “I would like to congratulate everyone at TC BioPharm.
“When I visited recently, I was hugely impressed by the cleanrooms and by the plans to become a world class provider of cell therapies.
“This part of the M8 corridor is really becoming a key centre for biotech companies and North Lanarkshire Council is determined to support this development.”