4basebio secures GMP license to supply clinical-grade synthetic DNA
Biotech innovator 4basebio (Cambridge, UK) has received UK regulatory approval to produce GMP-grade synthetic DNA.
4basebio – a biotech firm specializing in next-generation cell and gene therapies and vaccines – has been granted a Good Manufacturing Practice (GMP) license by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), authorizing it to manufacture and supply clinical-grade synthetic DNA. The certification marks an important milestone in 4basebio’s mission to advance gene therapies, vaccines and clinical research.
The ability to chemically synthesize DNA oligonucleotides and assemble them into functional units has become a cornerstone technology in modern molecular biology. As of 2024, the global market for DNA synthesis was valued at approximately US$4.56 billion and is projected to grow significantly in the coming years. Advancements in cost-effective, high-quality DNA synthesis methods like those provided by 4basebio will not only make these technologies more accessible but also enable researchers to test broader biological hypotheses.
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Focused on scalable synthetic DNA production and nanoparticle delivery technologies, 4basebio’s DNA platform is designed for speed, safety and performance. The technology offers a safer and more efficient alternative to traditional plasmid DNA, which faces limitations such as costly and slow fermentation processes, scaling difficulties, and undesirable immune responses.
With the new certification, 4basebio can use its platform to provide high-quality DNA products as both a starting material and drug substance for investigational medicinal products, which include applications in DNA and mRNA-based vaccines, as well as cell and gene therapies.
“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,” commented 4basebio’s CEO Heikki Lanckriet.
Following a £40 million investment in 2024, this regulatory approval supports 4basebio’s goal of further expanding their global manufacturing capabilities.
