4basebio Plc - 4basebio Receives GMP Licence for its UK DNA Manufacturing Facility
PR Newswire
LONDON, United Kingdom, April 02
2 April 2025
4basebio PLC
("4basebio" or the "Company")
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."
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 as amended by regulation 11 of the market abuse (amendment) (EU Exit) regulations 2019/310.
For further enquiries, please contact:
4basebio PLC Dr. Heikki Lanckriet, CEO | +44 (0)1223 967 943 |
Nominated Adviser Cairn Financial Advisers LLP Jo Tuner / Sandy Jamieson / Ed Downes | +44 (0)20 7213 0880 |
Joint Broker RBC Capital Markets Rupert Walford / Max Avison / Kathryn Deegan | +44 (0)20 7653 4000 |
Joint Broker Cavendish Capital Markets Limited Geoff Nash / Nigel Birks | +44 (0)20 7220 0500 |
Notes to Editors
About 4basebio
4basebio (AIM: 4BB) is an innovation driven life biotechnology company focused on accelerating the development of advanced therapy medicinal products (ATMPs) through its high-performance synthetic DNA products and non-viral, cell targeting nucleic acid delivery platform. The Company's objective is to become a market leader in the manufacture and supply of high-quality synthetic DNA products for research, therapeutic and pharmacological use as well as development of target specific non-viral vectors for the efficient delivery of payloads in patients.
Forward-looking statements
This announcement may contain certain statements about the future outlook for 4basebio. Although the directors believe their expectations are based on reasonable assumptions, any statements about future outlook may be influenced by factors that could cause actual outcomes and results to be materially different.
