Touchlight’s facility in Hampton, UK has received GMP certification, making the CDMO the first synthetic DNA manufacturer globally to gain regulatory approval to produce Active Pharmaceutical Ingredients (APIs).

Specifically, Touchlight has received a Manufacturer’s Authorization 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.

The facility, located in Hampton, West London, and completed in 2023, has 11 manufacturing suites and a capacity of >8kg per year. Under the newly acquired MHRA license, Touchlight has begun manufacturing API material.

Karen Fallen, CEO of Touchlight, said, “We are extremely proud to have received GMP certification of our UK facility. It is a 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.”