A U.K. initiative to accelerate the academia-led development of gene therapies is now seeing its first academic customers. Innovation Hubs for Gene Therapies, a network of dedicated manufacturing facilities funded by an independent research charity and two public funding bodies, were set up in 2021 and now offer a range of services.

“We’re halfway through our five-year funding, but much of our first couple of years was taken up with validation, recruitment, and setup,” explains Sophie Mountcastle, PhD, network manager for the Innovation Hubs. Mountcastle spoke about the Hubs and new services at Terrapinn’s Advanced Therapies conference in March.

According to Mountcastle, services now include lentiviral vector manufacturing up to 50 L, and the capacity to manufacture adeno-associated viruses (AAV) in both adherent and suspended cell cultures. Many early projects are working on rare diseases, as LifeArc, the independent research charity co-funding the project, has a major focus on these disorders.

“We’re well positioned to assist rare disease projects that need to get further down the pathway with clinical data before they’re commercially viable for investment or to have a commercialization strategy,” she says.

Priority for the Hubs

The priority for the three dedicated Hub facilities, at King’s College LondonNHS Blood and Transplant in Bristol, and the University of Sheffield, is on providing services to U.K. academia.  However, continues Mountcastle, they’re also open to looking at industrial and overseas projects if slots are available in their manufacturing pipeline.

“We’re keen to work with industry on tackling sector-wide challenges in process development, such as in product characterization and harmonization of assays,” she says. “Please do get in touch if you want to put in a bid for collaborative research and development or, for example, test your new technology in a GMP environment.”

The Hubs, Mountcastle notes, first put forward as a concept in a regenerative medicine report in 2019, aimed to solve problems faced by U.K. academia in commercializing gene therapies. These included struggling to secure manufacturing slots due to being in competition with larger projects, and a lack of knowledge about moving to GMP manufacturing.

Academia may need advice on the translational elements of clinical trials and regulation, which, she believes, “they may not get from a [traditional contract manufacturer].

The Hubs are all located in academic and healthcare research institutions, she explains, and the directors of each Hub have experience bringing gene therapies to the clinic. The Hubs are funded by the independent research charity LifeArc, the Medical Research Council, and the Biotechnology and Biological Sciences Research Council.

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