Pentlands Science Park-based TC Biopharm Ltd (TCB) has been given the go-ahead from the Medicines Healthcare Products Regulatory Agency (MHRA) to begin production of human cell therapy products at its new clinical manufacturing facility in Glasgow (pictured).
The multi-million pound building at Maxim Park in Glasgow is set to become a hub for immuno-cell therapy research, benefiting cancer patients throughout the UK and Europe.
TCB’s novel 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 its strategic partner Medinet in Japan.
TCB plans to treat the first cohort of patients later this year, working alongside established cancer clinics in the UK.
In addition to the pioneering use of immune cells to treat cancer, TCB plans to treat early-diagnosis HIV patients with its innovative treatment.
TCB worked with Gateshead-based WH Partnership, one of the UK’s leading cleanroom design, engineering and construction companies, to complete the build in record-time.
The build took 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.
New facilities include two independent GMP cleanrooms, process development laboratories and a quality control suite that allows in-house environmental monitoring and product testing and release.
WH Partnership's Managing Director, Nigel Hall, said: “We have gained a strong reputation for our cleanroom design and construction in the biotechnology industry and it is pleasing to demonstrate our expertise on a project as important as this one – especially so close to home.”
In addition to building the new facility, WH Partnership has also invested in TCB alongside the Scottish Investment Bank.
Angela Scott, TCB’s operations director, said: “The team has done an amazing job building and commissioning our facility in record time. Not only have WHP built an impressive GMP facility in the heart of Scotland, they also ensured that costs were managed in a supportive and proactive manner.
“As TCB’s clinical outreach extends beyond the UK, WHP and TCB will jointly evaluate logistics of facility expansion on a geographical basis, using a combination of modular and mobile clean room systems that can be located in strategic areas to support planned treatment regimes.”