TC BioPharm announces completion of its Clinical Manufacturing Facility at Maxim Park, Glasgow

Alongside founding investors and strategic partners MEDINET, seed fund investment of £250k from the Scottish Investment Bank – the investment arm of Scottish Enterprise - has allowed TC BioPharm (TCB) to build state-of-the-art cleanroom facilities and offices, moving the company one-step closer to treating cancer patients during 2015.

Constructed to comply with UK ‘Good Manufacturing Practice’ regulations, the complete build took just 12 weeks from start to finish. Comprising offices, two cleanrooms, quality control suites and development laboratories, the total footprint extends to 5,000 sqft, of which 3,500 sqft is designed to support manufacture of clinical grade product.

TCB worked closely with WH Partnership (Gateshead), one of the UK’s leading cleanroom design, engineering and construction companies, to complete the build in record-time. In addition to building the facility, the Board of WH Partnership elected to invest in TCB alongside the Scottish Investment Bank.

Additional support for the build was provided by Maxim Park, who generously supported much of the Cat-A office fit-out.

TCB’s technology uses patients’ own immune cells grown in culture to target cancer, and has a safe history based on the treatment of numerous patients by MEDINET in Japan. TCB has obtained Scientific Advice from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) which has 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 in Glasgow, Southampton and Birmingham.

Based in North Lanarkshire at the Eastern end of Glasgow’s BioCorridor, the new cleanroom facility will require an IMP (Investigational Medicinal Product) licence from the MHRA before clinical product can be made. Stating the importance of this licence - Angela Scott, TC BioPharm’s operations director commented, ‘the team have done an amazing job building and commissioning our GMP cleanrooms here in Glasgow, all our efforts are now focussed on meeting UK regulations, prior to MHRA inspection of the facility in November’.

Craig Ritchie, Maxim Park director said: 'We are thrilled to help TC BioPharm locate its clinical manufacturing and office facilties at Maxim Park. It is a credit to our highly accessible location, great on-site amenities and flexible space that this fantastic organisation elected to locate here.’

Paul Lewis, managing director of operations at Scottish Enterprise, added: ‘Commercialisation of this ground-breaking cancer therapy in Scotland further cements our global reputation for regenerative medicine and stratified medicine. Congratulations to the team At TC BioPharm for establishing this new facility in such a short space of time. This is an exciting milestone for the company and is a great example of the ongoing international collaboration we have with Japan. Scottish Enterprise looks forward to continuing to work with TC BioPharm to help realise its ambitious growth plans.’

Enterprise Minister Fergus Ewing said: “The creation of new jobs is a fantastic boost for Scotland’s expanding biotechnology industry. Scotland has a strong industrial sciences backbone, our life sciences sector is one of the largest and fastest-growing in Europe, whilst our chemical industry is the country’s second top exporter – equating to £4.5 billion per year.

“Through the support from MEDINET and Scottish investors, TCB's investment to support further clinical studies and boost the Scottish economy will allow Scotland to be at the forefront of global transformational change to a biotechnology-inclusive economy.”

TCB’s executive chairman Dr Artin Moussavi said: ‘The team is rapidly advancing towards launch of a novel cell therapy for treatment of cancer patients in Europe, and opening of our clinical manufacturing facility marks an important milestone along this journey. The initial target indication is melanoma, a significant unmet medical need. We believe our gamma delta T cell platform has an excellent chance of providing safe and effective therapy for these patients.’