Synthetic DNA manufacturer 4basebio has been GMP certified by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
This follows the company's £40m investment into its scalable synthetic DNA manufacturing capacity in 2024.
4basebio can now support its customers and cell & gene therapy and vaccine development partners, providing clients with GMP-grade synthetic DNA that can be used in clinical programmes.
Certification from the MHRA allows 4basebio to facilitate the production of investigational medicinal products for clinical trials — including DNA and mRNA based vaccines, as well as cell & gene therapies.
With this achievement, the company plans to drive further advancements in the synthetic DNA niche, bringing products incorporating this technology into the mainstream.
“Our long-term vision is to become a leading player in the DNA space," noted CEO of 4basebio, Heikki Lanckriet.
"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.”
Amy Walker, COO, 4basebio, added: “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 commercialisation,” she concluded.