Touchlight Becomes First Synthetic DNA Manufacturer to Achieve GMP Certification for API Production

15 January 2025 | Wednesday | News


With MHRA approval, Touchlight's Hampton, UK facility sets a new standard in GMP manufacturing, supporting DNA vaccines and non-viral gene therapies with its innovative dbDNA technology.

 Touchlight, an innovation-driven Contract Development and Manufacturing Organisation (CDMO), 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.

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