4basebio Secures GMP Certification, Cementing Its Role in Next-Generation DNA Therapeutics
Cambridge-based biotech firm 4basebio PLC has achieved a major milestone in its mission to revolutionise DNA-based therapeutics by securing Good Manufacturing Practice (GMP) certification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
This pivotal accreditation grants the company the authority to supply GMP-grade synthetic DNA for use in clinical programmes across cell and gene therapy as well as vaccine development.
This certification marks a turning point in 4basebio’s growth trajectory and unlocks new potential for its proprietary synthetic DNA platform, known for delivering high-performance, flexible DNA tailored to a wide range of therapeutic and research applications.
Now with a GMP licence in hand, the company is positioned to provide synthetic DNA as both a critical starting material and a drug substance, supporting the development of DNA and mRNA vaccines, among other advanced therapeutic solutions.
The announcement follows 4basebio’s £40 million investment in 2024, which was aimed at scaling up the company’s capabilities to meet global demand for high-quality DNA products.
This strategic move underscored the company’s commitment to building a world-class infrastructure for the production and supply of synthetic DNA, setting the stage for this latest regulatory success.
Commenting on the achievement, the company’s CEO shared the long-term ambition to become a leading player in the DNA space, noting that this GMP milestone is a key step in realising that vision.
They stated that their goal is to support the development of cutting-edge therapies, and GMP certification allows them to do just that by supplying synthetic DNA of the highest standard for clinical use.
Meanwhile, the company’s COO highlighted the advantages of 4basebio’s technology, explaining that the proprietary platform is faster, more efficient, and produces DNA with a superior safety profile when compared to conventional plasmid DNA and other synthetic alternatives.
This competitive edge not only enhances therapeutic development but also reduces risks in clinical translation, helping partners move from concept to commercialisation with greater confidence.
With GMP certification secured, 4basebio is now poised to expand its service offering, supporting clients at every stage – from research and pre-clinical trials to full clinical deployment and commercial supply.
What’s more, the company plans to continue pushing the boundaries of synthetic DNA innovation, investing in advanced technologies to enable scalable, reliable, and safe DNA solutions for a global market.
In conclusion
4basebio’s GMP certification from the MHRA represents more than a regulatory green light – it is a symbol of the company’s growing influence in the life sciences sector.
Backed by significant investment, a proprietary high-performance DNA platform, and a clear vision for the future, 4basebio is set to play a transformative role in the evolving landscape of genetic medicine and vaccine development.
News Credits: 4basebio receives MHRA licence for synthetic DNA manufacture
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