Biotechnology start-up TC BioPharm (TCB) has been given the go-ahead to create human cell therapy products at its new Scottish lab, in what it calls “a vital process in the fight against cancer”.
The Edinburgh-based firm said yesterday that following an inspection of its new facility at Maxim Park, North Lanarkshire, the Medicines Healthcare Products Regulatory Agency (MHRA) had granted a licence to start production.
TCB’s technology, which uses patients’ own immune cells grown in culture to target cancer and viral infections, is based on numerous treatments by strategic partner Medinet in Japan. The two firms teamed up last year and secured more than £1 million to develop a “novel” treatment for various cancers.
They are supported by Scottish Development International, the overseas arm of Scotland’s enterprise agencies, with a £500,000 regional selective assistance grant.
TCB also obtained scientific advice from the MHRA and now plans to treat the first cohort of patients this year, working alongside established cancer clinics throughout Scotland.
The multi-million-pound facility built at Maxim, at Eurocentral, which includes two independent cleanrooms as well as laboratories and a quality control suite, is set to become a hub for immuno-cell therapy research to benefit cancer patients in the UK and Europe.
TCB chief executive Michael Leek said: “Investing substantial amounts of cash and manpower upfront to build this amazing, state-of-the-art cleanroom facility has paid dividends.
“As we move our immunotherapy platform towards clinical studies in cancer, the MHRA licence 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.”
The complete build took just 12 weeks, plus another 12 weeks to commission the facility and its equipment and train staff.
The facility has the flexibility and capacity to treat both cancer patients and individuals with major viral infections, and TCB also plans to treat early-diagnosis HIV patients.
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