Advent BioServices’ gains MHRA certification for Sawston Business Park site
Northwest Biotherapeutics has secured MHRA certification for its cancer vaccine trials in the Sawston Business Park, sparking delight for site developer Advent BioServices.
Advent, which is based on the Park, has completed the laboratory facilities to UK regulatory standards on behalf of Northwest Biotherapeutics, which is headquartered in Bethesda, Maryland. The US-based clinical stage biotechnology company is focused on the development of personalised cancer vaccines designed to treat a broad range of solid tumour cancers. Its dendritic cell-based cancer vaccine is a fully personalised immunotherapy treatment that mobilises the entire immune system to fight many types of solid tumour cancers.
NW Bio’s Sawston R&D team is working on a cancer vaccine for glioblastoma multiforme, the most aggressive type of brain cancer. Phase III data is expected in the near future. The treatment has been described as a ‘major breakthrough’ in the treatment of glioblastoma, following the publication of blinded interim results in the Journal of Translational Medicine.
This therapy has been in development for a long time and is finally getting closer to reaching the people who can potentially benefit. Last month, the company’s state-of-the-art manufacturing facility on Sawston Business Park received MHRA approval for the manufacture of GMP cell therapy products under the UK ‘specials’ regime (for their compassionate use programme, offered by Dr Paul Mulholland at UCL).
The facility will have the capacity to produce therapies for 450-500 patients per year and is one of the most advanced cell and gene therapy manufacturing facilities in the world.
Advent BioServices began as a cell therapy contract development and manufacturing organisation (CDMO) in 2016. Currently there are 40 staff working on the site, of whom about 40 per cent are scientists.
Dr Mike Scott, who joined Advent as COO in April 2019, has overseen the design.
“Advent was contracted to build out the facility in 2019,” Mike says. “The warehouse was already at the site, and we’re further developing it – it’s about 90,000sq feet dedicated to cell therapies, officially referred to as ‘advanced therapy medicinal products’, or ATMPs. We’ve built out around one-fifth of the whole building. When fully built out, it will be one of the largest facilities of its kind in Europe or North America.”
The MHRA accreditation allows GMP (clinical grade) manufacturing of medical products to commence in the Sawston facility.
“The MHRA manufacturing approval is connected to the site at Sawston Business Park,” Mike says, “and Advent is contracted to put together everything for that licensing, which was granted in mid-December.
“So, from now, advanced cell therapy products can be manufactured in the building.”
Mike has impeccable credentials for overseeing the company’s development work, having been director of the cellular therapy facility at Cambridge University Hospitals NHS Foundation Trust for more than 20 years before arriving at Advent.
“I really enjoy the job and the challenges,” he says of the role. “We now have a state-of-the-art facility here at Sawston in addition to a certificate received last year from the Human Tissue Authority which allows us to process and store cell and tissue for medical purposes. The facilities include GMP clean rooms for the production of human cell products, research and process development laboratories, and a large cryo-storage facility.”
He adds: “I came here thinking it would take much longer to obtain our regulatory licences, but my team has worked tirelessly and managed to get it done sooner despite being in the midst of a pandemic and despite serious supply chain difficulties especially for specialised equipment and materials.”
The progress in bringing this facility together was supported in part by a £1.35m loan from the Cambridgeshire and Peterborough Economic Development Authority for the Phase 1a build-out and equipment.
NW Bio originally owned the Sawston site, having bought it from previous owners Spicer in 2014. The 550-acre site was then sold to Chinese technology company Huawei for £37.5m in an off-market deal handled by Bidwells in 2019. As part of the transaction NW Bio entered into a leaseback agreement for 87,000sq ft of space at £500,000 per annum for 20 years. NW Bio currently has a contracted team of more than 40 staff on the site, which could expand to 300 when the project is fully completed.