The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Touchlight’s Hampton facility a Manufacturer’s Authorisation for Investigational Medicinal Products (MIA, IMP) licence, marking a significant advancement in synthetic DNA production. This certification enables the manufacture of Investigational Active Pharmaceutical Ingredients (API) and critical starting materials for Advanced Therapy Medicinal Products (ATMP).

Technical specifications

The facility, completed in 2023, comprises 11 manufacturing suites with an annual production capacity exceeding 8 kg of DNA – surpassing current global supply levels. Touchlight’s proprietary doggybone DNA (dbDNA) technology produces linear, minimal, covalently closed DNA vectors without antibiotic resistance genes, offering enhanced expression characteristics compared to conventional vectors.

Clinical applications

The dbDNA platform has demonstrated versatility across multiple therapeutic modalities, including viral vectors, mRNA therapeutics, genome editing applications, and DNA vaccines. Several client products utilising dbDNA have progressed into clinical development across US and European jurisdictions, with three products currently in clinical trials, one submission filed, and multiple projects initiating regulatory engagement. Notably, the company manufactured dbDNA for a pivotal study in 2024.

Regulatory implications

This certification establishes a regulatory framework for synthetic DNA production, potentially transforming the manufacturing landscape for genetic medicines. The approval validates synthetic DNA as a viable alternative to traditional plasmid DNA methods, offering advantages in production speed and regulatory compliance.

Karen Fallen, CEO of Touchlight, commented on the achievement: “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.”

The company’s CDMO services now cover pre-clinical development through to commercial supply, including technology transfer for inhouse implementation. This comprehensive offering, coupled with the GMP certification, establishes Touchlight as a significant contributor to the advancement of genetic medicine manufacturing.