Touchlight becomes the first synthetic DNA API manufacturer to receive GMP certification

Published: 15-Jan-2025

The CDMO's Hampton, UK facility has received GMP certification to produce investigational APIs and critical starting materials for DNA vaccines and non-viral gene therapies

Touchlight's Hampton, UK has received GMP certification from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to produce synthetic DNA as an active pharmaceutical ingredient (API).

This makes the company the first DNA manufacturer globally to gain regulatory approval to produce an API.

Through this approval, Touchlight will be better equipped to support DNA vaccine and non-viral gene therapy developers who want to outsource their manufacturing processes.

The MHRA has granted Touchlight with a Manufacturer's Authorisation for Investigational Medicinal Products (MIA, IMP) license, which allows them to produce investigational APIs and critical starting materials.

 

dbDNA

Since its founding in 2007, Touchlight has developed its services and technologies to support customers in the gene therapy space.

Currently, the company's most popular asset is its doggybone DNA (dbDNA) technology; the a linear, minimal covalently closed DNA vector contains no antibiotic resistance genes, enabling enhanced expression compared with other vectors.

This, according to Touchlight, makes it an ideal API for DNA vacines and non-viral gene therapy applications.

The company produces dbDNA at its facility in Hampton, which has 11 manufacturing suites and an annual capacity of more than 8kg per year.

GMP certification at the Hampton site has progressed the synthetic DNA field significantly, establishing a new standard to produce scalable DNA products with improved purity versus plasmid DNA.

This highlights the potential of synthetic DNA as a viable alternative to plasmid DNA methods — both as a starting material and also as an API.

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, one 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”.

 

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