Touchlight Achieves GMP Certification for UK Synthetic DNA Facility

• Touchlight’s Hampton facility has received GMP certification, making it the first synthetic DNA manufacturer globally to gain regulatory approval for API production.

• The company’s dbDNA technology supports advanced therapies, including DNA vaccines, non-viral gene therapies, and genome editing.

Touchlight, an innovation-focused Contract Development and Manufacturing Organisation (CDMO), has announced GMP certification of its facility in Hampton, UK. The achievement positions the company as the first globally to gain regulatory approval for synthetic DNA Active Pharmaceutical Ingredient (API) production, supporting its growing portfolio of advanced therapies.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) awarded Touchlight a Manufacturer’s Authorisation for Investigational Medicinal Products (MIA, IMP) license. This allows GMP production of investigational APIs and critical materials for Advanced Therapy Medicinal Products (ATMPs). The Hampton site, completed in 2023, features 11 manufacturing suites with an annual capacity exceeding 8kg—more than the current global DNA supply.

Touchlight’s proprietary dbDNA technology is a linear, closed DNA vector devoid of antibiotic resistance genes, offering superior expression compared to traditional plasmid DNA. The technology is currently used in clinical projects across the US and Europe, including pivotal studies. CEO Karen Fallen noted, “This GMP certification is a testament to the hard work we have put in to pioneer a regulatory framework for our novel technology.”