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.

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.

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About Touchlight

Touchlight is an innovation-driven leading CDMO pioneering enzymatic GMP DNA production to enable the genetic medicine revolution. As pioneers, with an FDA Drug Master File accepted in 2022 followed in 2025 with the world’s first cell-free DNA GMP license, Touchlight’s enzymatic DNA technology is on the cutting edge of AAV, mRNA, DNA vaccine, and gene editing technology with its state-of-the-art facility recognised by ISPE’s Facility of the Year Awards (FOYA) for Innovation.

With multiple client products already in the clinic, Touchlight’s evidence-based, synthetic DNA manufacturing solutions offer a scalable, sustainable alternative to plasmid DNA (pDNA) for all stages of pre-clinical, clinical and commercial development. The company and technology are built on the conviction that DNA is fundamental to the future of medicine. Traditional methods, based on bacterial fermentation, are slow, costly, and unable to meet the growing demands of genetic medicine due to limited scalability and speed. Founded in 2007, Touchlight’s team is inspired by breakthroughs in genetic medicine, recognising the urgent need for innovative DNA production techniques to support the future of genetic therapies.

For more information please contact:

Karen Fallen, Chief Executive Officer
Verna McErlane, Chief Commercial Officer
E: info@touchlight.com
T: +44 20 8481 9200