4basebio Receives GMP Licence for its UK DNA Manufacturing Facility

Cambridge, UK, 2 April 2025 – 4basebio PLC (AIM: 4BB), an innovation-led provider of novel synthetic DNA products and a non-viral, thermostable nucleic acid delivery platform, today announced that it has received Good Manufacturing Practice (GMP) certification from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its UK DNA manufacturing facility.

The GMP certification (MIA) granted by the MHRA authorises 4basebio to manufacture and supply both Investigational Medicinal Product (IMP) Drug Substance (Active Pharmaceutical Ingredient; API) and Critical Starting Biological Medicinal materials used in Advanced Therapy Medicinal Products (ATMPs) from its state-of-the-art manufacturing facility in Cambridge.

The grant of the GMP certification marks a significant achievement for the Company, proving its ability to produce high-quality, advanced synthetic DNA that meets regulatory standards for clinical applications. The certification both strengthens the Company’s position in the field of advanced therapeutics and progresses the Company towards future product commercialisation and patient care for a range of advanced therapies.

Heikki Lanckriet, CEO of 4basebio, commented, “Achieving GMP certification is a critical milestone for 4basebio, validates our ability to supply synthetic DNA for clinical applications and underscores the hard work and innovation of our team and sets the stage for the next phase of growth for the Company.”