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Touchlight Genetics, in partnership with NPL, has secured funding from Innovate UK under their Innovative Technologies: Nucleic Acid Medicines Manufacture, Round 2 call.
The continued development of genome editing technologies and increased clinical activity with genome edited products is leading to significant demand for safe, efficient and manufacturable non-viral nucleic acid templates for targeted genome insertions, to replace the need for viral vectors.
In a bid to tackle this challenge, Touchlight has developed a novel, circular, single-stranded genome editing template known as MegaBulb DNA (mbDNA™). Their mbDNA shows low cellular toxicity and achieves high gene-length knock-in efficiencies, outperforming other non-viral technologies and rivalling viruses. mbDNA’s enzymatic manufacture, which leverages Touchlight’s established technologies & capabilities, allows for a robust and scalable process suitable for rapid development towards GMP production – and addresses a major bottleneck for non-viral gene therapy (NVGT) development.
The important next step is to comprehensively characterise mbDNA, develop relevant analytical methods, and rapidly scale up manufacture. With this funding, NPL and Touchlight will collaborate to inform specific metrics for the performance attributes of mbDNA. These will be assessed using NPL’s reference materials and procedures, including cryogenic electron microscopy. The results will facilitate a mechanism for more efficient ssDNA production through improving mbDNA’s manufacturability, as well as increasing the productivity and flexibility of Touchlight’s already established GMP manufacturing process.
Max Ryadnov, NPL Fellow, said: “The engineering biology revolution is posed to enrich the way we live and work. We are pleased to strengthen our collaboration with Touchlight and tangibly demonstrate our mission to supercharge the competitiveness of UK industry.”
This work aims to accelerate understanding of the manufacturing of novel nucleic acid platforms as well as advancing industry development within NVGT by rapidly making mbDNA widely available to the market. Advances will play an important role in establishing the UK as a global manufacturing hub for engineering biology, advanced therapies and genetic medicine.
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10 May 2024