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Facility will enable commercialization of genetic medicines.
May 25, 2023
By: Anthony Vecchione
Touchlight, a provider enzymatic DNA production, a critical material in many new genetic medicine treatments, completed the redevelopment and expansion of its UK manufacturing facility, housed in a repurposed Victorian waterworks on the banks of the River Thames. According to the company, the expanded state-of-the-art facility’s manufacturing capacity has tripled and is now capable of producing more than 8kg a year. This exceeds the current, but growing, global supply of plasmid DNA for genetic medicine. The new facility has 11 suites and includes two class B filling suites with class A filling cabinets, warehousing, together with a quality control laboratory capability and has already received a successful customer quality audit from a Big Pharma company. The 515m² facility now comprises 11 state-of-the-art good manufacturing practice (GMP) DNA manufacturing suites, bringing the total on site to 15, more than tripling the company’s DNA manufacturing capacity. Touchlight’s proprietary doggybone DNA (dbDNA) overcomes the technical challenges associated with efficiently mass-producing plasmid DNA. The patented dbDNA technology produces a minimal, linear, double stranded, covalently closed DNA vector through an enzymatic manufacturing process. dbDNA is uniquely positioned for the rapid, synthetic, and scalable manufacture of GMP DNA using a small, simple footprint. In addition, the technology can incorporate genes from 500bp to 20kb and accommodate sequences typically unstable as plasmid DNA in E. coli, such as those found in viral vector and mRNA production. Demand for DNA from biopharmaceutical companies is increasing exponentially given its critical role in genetic medicines, including mRNA vaccines and gene therapies, enabling the potential of emerging new drug classes such as gene-editing treatments and novel cancer therapies. Touchlight has contracts to supply many of the top ten biopharmaceutical companies in the world, including Pfizer, as well as Lonza. Karen Fallen, Touchlight’s CEO said, “doggybone DNA has many benefits over traditional DNA, offering an affordable and scalable alternative, as the biopharmaceutical industry continues to increase its investment in genetic medicine. The expansion of our facility announced today will help us further contribute to harnessing the huge potential of this new class of medicine, and we are excited to be working with some of the world’s most innovative companies as their manufacturing partner to do this.” The completion of the building project follows the US Food and Drug Administration (FDA) acceptance of a Drug Master File for GMP-grade dbDNA in December, and a further FDA approval a month later for the first investigational new drug application (IND) using dbDNA in an in-human trial planned by one of Touchlight’s clients. A dbDNA-derived AAV product previously entered clinical testing in Europe in 2022. Jonny Ohlson, Touchlight’s executive chair and founder, said: “Touchlight has a long-held belief that scientists, like all creatives, function best in beautiful spaces. Whilst it may not, on the face of it, seem logical to site a GMP manufacturing facility in a waterworks that has been derelict for 70 years, the site has a large footprint of beautiful Victorian buildings which, now converted, provide a stunning and iconic facility that is an inspiring place to work. I am sure our Victorian predecessors would be proud that we have converted it into one of the largest capacity DNA manufacturing sites in the world today.” In April, the company also won a substantial grant to accelerate its manufacturing program from the Life Sciences Innovative Manufacturing Fund, which is jointly backed by government and industry to support life sciences businesses investing in manufacturing projects in the UK. It completed a $125m fundraise in 2021.
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