4basebio Receives MHRA GMP Licence for Manufacture and Supply of Synthetic DNA

4basebio PLC (“4basebio”), a company which develops and commercializes the large-scale manufacture of synthetic DNA as well as nanoparticle delivery solutions, today announced that it has received Good Manufacturing Practice (GMP) certification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The licence enables the Company to support its customers and partners in the fields of cell and gene therapy and vaccine development with GMP-grade synthetic DNA for their clinical programs.

4basebio’s proprietary synthetic DNA platform is built to be flexible, providing high-performance DNA products tailored to specific applications. With its GMP licence, the Company is authorised to supply synthetic DNA both as a critical starting material and drug substance for a wide range of therapeutic applications, including DNA and mRNA-based vaccines, and cell and gene therapies.

Attaining a GMP licence has been a key objective for 4basebio as it allows the Company to directly contribute to the production of investigational medicinal products (IMPs) for clinical trials. The announcement follows the completion of the Company’s £40 million investment announced in 2024, which marked a significant milestone in the team’s journey to deliver scalable, high-quality synthetic DNA solutions to the global market.

Looking to the future, 4basebio is focused on continuing its rapid growth while expanding its capabilities. The Company plans to leverage its GMP certification to drive further advancements in the synthetic DNA field and lead the way in providing high-quality DNA products for use in clinical trials and commercialization.

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. It enables us to support our clients along their entire journey from discovery and research phases into both pre-clinical and clinical stages and in due course into commercial supply. This achievement underscores the hard work and innovation of our team and sets the stage for the next phase of growth of the Company.”

Heikki Lanckriet, CEO, 4basebio

Amy Walker, COO, 4basebio, 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. We are able to offer our clients a rapid and scalable solution for their clinical trials and future product commercialization.”