TC BioPharm constructs clinical manufacturing facility in Scotland
Working closely with UK cleanroom design, engineering and construction company WH Partnership, the facility was constructed to comply with UK GMP regulations and took 12 weeks to build. It includes offices, two cleanrooms, quality control suites and development laboratories in a 5,000 square foot space, of which 3,500 square feet is designed to support the manufacture of clinical grade product.
TC BioPharm, alongside Japan’s Medinet, is looking to use patients’ own immune cells grown in culture to target cancer. The company hopes to treat the first cohort of melanoma patients during 2015, working with cancer clinics in Glasgow, Southampton and Birmingham.
The company said it has obtained scientific advice from the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency) which has provided a clear roadmap to clinical studies.
The new cleanroom facility will still require an IMP (Investigational Medicinal Product) licence from the MHRA before clinical product can be made. Angela Scott, TC BioPharm’s operations director noted that MHRA inspections of the facility will begin in November.
Alongside founding investors and strategic partners Medinet, seed fund investment of £250,000 ($408,000) from the Scottish Investment Bank (the investment arm of Scottish Enterprise) has allowed TC BioPharm to build state-of-the-art cleanroom facilities and offices.
TCB’s executive chairman 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.”
