Touchlight Genetics, in partnership with the National Physical Laboratory (NPL) have secured funding from Innovate UK under their Innovative Technologies: Nucleic Acid Medicines Manufacture, Round 2 call. 

As the development of genome editing technologies continues to gather pace, Touchlight has developed a novel, circular, single-stranded genome editing template known as MegaBulb DNA (mbDNA™). 

Increasing 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. Touchlight’s 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.

This funding will enable Touchlight, with the support of NPL, to comprehensively characterise mbDNA, develop relevant analytical methods, and rapidly scale up manufacture. The project will inform specific metrics for the performance attributes of mbDNA and manufacture, which will be assessed using NPL’s reference materials and procedures. The project 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.

Karen Fallen, Chief Executive Officer of Touchlight, said: “We are excited to partner with NPL to further develop our innovative mbDNA™ technology.  mbDNA’s superior knock-in efficiency and low toxicity, combined with our established GMP synthetic DNA manufacturing expertise has the potential to address current supply limitations for long single-stranded DNA, strengthening the UK's market position in the nucleic acid manufacture market for gene editing.”

Max Ryadnov, NPL Fellow, comments: “ 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 will serve to expedite overall understanding of the manufacturing of novel nucleic acid platforms and be pivotal in advancing industry development within NVGT by rapidly making mbDNA widely available to the market. Additionally, advances will play an important role in establishing the UK as a global manufacturing hub for engineering biology, advanced therapies and genetic medicine.