Platform academic lead: Professor Robin Ali
Platform service lead: To be appointed (Dr Shaun Cochrane interim)
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Uniquely placed world class expertise and services for first in human studies
The Advanced Therapies Manufacturing Platform has established expertise in the manufacturing of cellular advanced therapy medicinal products (ATMPs) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) GMP requirements. The platform is licensed by the MHRA to manufacture investigational ATMPs and specially manufactured or ordered (specials) products. It supports the BRC’s broad portfolio of advanced cell therapy clinical trials.
The Platform can accommodate multiple production processes across the BRC, academic and industry partners and can operate as either a Contract Manufacturing Organisation (CMO) or as a hotel facility. The Platform has manufacturing capabilities for both autologous and allogenic cell therapy manufacture as well as both adherent cell types and cells grown in suspension with significant experience in the manufacture of autologous T-regulatory cell therapies, viral vector modified CAR-T cells and mesenchymal stem cell educated monocytes. The platform infrastructure is currently being expanded to accommodate the production of a wider portfolio of cell therapies including embryonic stem cell-derived products.
- Production of a subset population of monocytes with anti-fibrotic properties for a first-in-human advanced cell therapy clinical trial using the monocytes as anti-fibrotic treatment in the Long COVID-19 setting of lung fibrosis (the MONACO trial).
- Production of autologous polyclonal T-regs for a first-in-human advanced cell therapy (the ThRIL Trial) to determine whether T-reg cells can induce immune tolerance and reduce the need for immunosuppression in liver transplant patients [Sánchez-Fueyo A, et al. (2020) Am J Transplant. 20(4):1125-1136].
- Production of autologous CD28-based CAR-T cells for a first-in-human trial to determine whether they can be used to treat intractable head & neck cancer (the T4 trial), with and without lymphodepletion [van Schalkwyk M, et al (2013) Hum Gene Ther Clin Dev. 24(3): 134-42].
- Production of autologous polyclonal T-reg cells to induce immune tolerance for first-in-human and follow-on Phase IIb trials in kidney transplant patients to determine whether this can reduce the need for immunosuppression (The ONE and TWO trials) [Sawitzki, B. et al. (2020) Lancet 395: 1627–39].
- Production of autologous, enriched T-reg sub-population reprogrammed to home to the gut, for a first-in-human trial to determine whether this can be used to treat Crohn’s Disease (The TRIBUTE trial) [Canavan, J. et al (2015) Gut. 65(4): 584-594].