4basebio secures MHRA GMP certification for synthetic DNA production
Cambridge-based 4basebio has received Good Manufacturing Practice certification from the UK’s Medicines and Healthcare products Regulatory Agency, enabling the company to supply GMP-grade synthetic DNA for clinical applications in cell and gene therapy development.
Regulatory milestone advances synthetic DNA capabilities for clinical trials
4basebio PLC has announced the receipt of Good Manufacturing Practice (GMP) certification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), marking a significant advancement in the company’s ability to serve the clinical research sector. The certification authorises 4basebio to manufacture and supply GMP-grade synthetic DNA for use in clinical programmes, specifically targeting applications in cell and gene therapy and vaccine development.
The Cambridge-based company has developed a proprietary synthetic DNA platform designed to provide tailored, high-performance DNA products. With this regulatory approval, 4basebio is now positioned to supply synthetic DNA both as a critical starting material and as a drug substance for therapeutic applications, including DNA and mRNA-based vaccines and various cell and gene therapies.
Technical advantages over conventional DNA production methods
The company’s synthetic DNA technology offers several technical advantages over traditional methods. According to Amy Walker, COO of 4basebio: “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.”
This technological edge could prove particularly valuable in the fast-developing field of nucleic acid therapeutics, where manufacturing quality, speed, and scalability are critical factors in advancing candidates from research into clinical development.
Strategic investment supports commercial expansion
The GMP certification follows the completion of a £40 million investment announced by the company in 2024, which has supported 4basebio’s efforts to scale its synthetic DNA manufacturing capabilities. This substantial capital infusion has enabled the company to develop the infrastructure necessary to meet GMP standards and position itself as a supplier to clinical-stage biopharmaceutical companies.
Heikki Lanckriet, CEO of 4basebio, emphasised the strategic importance of this certification: “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.”
Impact on investigational medicinal product development
For developers of cell and gene therapies, the availability of GMP-grade synthetic DNA from 4basebio represents an additional option in the critical supply chain for investigational medicinal products (IMPs). The certification specifically allows 4basebio to contribute directly to IMP production for clinical trials, potentially accelerating the development timeline for novel therapeutic candidates.
As the company continues its expansion, this regulatory milestone positions 4basebio to play an increasingly significant role in the nucleic acid therapeutics manufacturing ecosystem.
