4basebio receives MHRA licence for synthetic DNA manufacture

GMP certification enables 4basebio to supply DNA for clinical trials

4basebio PLC has been granted Good Manufacturing Practice (GMP) certification by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This licence authorises the supply of GMP-grade synthetic DNA to support clinical programs in cell and gene therapy and vaccine development.

The Cambridge-based company’s proprietary synthetic DNA platform delivers flexible, high-performance DNA tailored to diverse applications. With the GMP licence, 4basebio can provide synthetic DNA as a critical starting material and drug substance for therapies, including DNA and mRNA vaccines.

CEO Heikki Lanckriet said: “Our long-term vision is to become a leading player in the DNA space. This milestone highlights our commitment to supporting the development of cutting-edge therapies by providing GMP-grade synthetic DNA for clinical trials.”

The GMP certification follows the company’s £40 million investment, announced in 2024, which marked a significant step in its journey to deliver scalable, high-quality DNA solutions globally. COO Amy Walker explained: “Our platform is faster, more efficient, and offers higher performance products with a better safety profile compared with traditional plasmid DNA and other synthetic DNA products.”

4basebio aims to expand its capabilities further, advancing synthetic DNA technologies and continuing its growth in providing scalable, high-quality solutions for clinical trials and product commercialisation.

The company’s commitment to innovative therapies and GMP-grade DNA products positions it at the forefront of the synthetic DNA field, supporting clients from research phases through to pre-clinical, clinical, and commercial supply.