Touchlight’s dbDNA™ Manufacturing Facility Receives World-First GMP License from MHRA

• Touchlight’s dbDNA technology is the first synthetic DNA technology to receive a GMP certificate globally

• Touchlight manufacturing Active Pharmaceutical Ingredient (API) on behalf of contracted clients

Touchlight, an innovation-driven Contract Development and Manufacturing Organisation (CDMO), today announced that its facility in Hampton UK has received GMP certification. As a result, Touchlight becomes the first synthetic DNA manufacturer globally to gain regulatory approval to produce Active Pharmaceutical Ingredient (API), enabling the company a unique position to support its growing customer base in developing DNA vaccines and non-viral gene therapies.

Specifically, Touchlight has received a Manufacturer’s Authorisation for Investigational Medicinal Products (MIA, IMP) license from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the GMP (Good Manufacturing Practices) production of Investigational API and Critical starting materials in Advanced Therapy Medicinal Products (ATMP) from its manufacturing facility.

Touchlight is the global leader in the production of synthetic DNA products. Touchlight‘s dbDNA technology, a linear, minimal, covalently closed DNA vector, contains no antibiotic resistance genes, enabling better expression than comparator vectors and thus is an ideal API for DNA vaccines and non-viral gene therapy applications. The state-of-the-art facility, located in Hampton, West London and completed in 2023, has 11 manufacturing suites and a capacity of >8kg per year – greater than the current global supply of DNA. Under the newly acquired MHRA license, Touchlight has begun manufacturing API material.

Touchlight is enabling advanced therapies with its dbDNA technology in applications including viral vectors, mRNA, genome editing and DNA vaccines. Numerous client products have implemented dbDNA for clinical development in the US and Europe, including three currently in the clinic, 1 filed and multiple further clinical projects that have initiated regulatory engagement. Additionally, Touchlight manufactured dbDNA for a pivotal study in 2024.  These programmes reflect the transformative nature of dbDNA to improve the economics and safety of scaling advanced therapies.

Karen Fallen, CEO of Touchlight, said “We are extremely proud to have received GMP certification of our UK facility. It is testament to the hard work we have put in to pioneer a regulatory framework for our novel technology. We have assembled a team with deep expertise and built the facility, supply chain and technology robustness needed to deliver these important projects for our customers”.

This GMP certification marks a pivotal moment for the synthetic DNA field, establishing a new standard to produce scalable DNA products with improved purity versus plasmid DNA. Touchlight’s achievement demonstrates that synthetic DNA, with its rapid production and improved regulatory profile, is now a viable alternative to plasmid DNA methods as a starting material and also an API. This milestone further validates the dbDNA platform as the best-in-class synthetic DNA vector for advanced therapy.

About Touchlight

Touchlight is a privately-owned innovation-driven CDMO based in London, U.K., focused on the provision of DNA services and manufacture of enzymatically produced doggybone DNA (dbDNA™) to enable the development of genetic medicines. Touchlight provide rapid, enzymatic DNA development and manufacturing for all advanced therapy production, including mRNA, viral and non-viral gene therapy and DNA API. dbDNA is a minimal, linear, covalently closed structure, which eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies. Clients can be supported from pre-clinical through development and supply, to licencing and tech transfer for use in-house.