Biotechnology company 4basebio PLC (AIM: 4BB) announced on Wednesday that it has obtained Good Manufacturing Practice (GMP) certification from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for its DNA manufacturing facility in Cambridge.
The certification authorises the company to manufacture and supply Investigational Medicinal Products (IMP) Drug Substance and Critical Starting Biological Medicinal materials for Advanced Therapy Medicinal Products (ATMPs).
This milestone strengthens 4basebio's position in advanced therapeutics and moves the company closer to commercialisation, supporting future clinical applications and patient care in the ATMP sector.
4basebio is focused on developing high-performance synthetic DNA products and non-viral, cell-targeting delivery systems for research, therapeutic and pharmacological applications. Its goal is to lead the market in providing high-quality DNA products and advanced delivery solutions.
GRIN Therapeutics' radiprodil granted Priority Medicine designation in Europe
AKAGERA Medicines completes first cohort in phase 1 SAD/MAD study of AKG-100
Yingli Pharma's linperlisib Phase 3 registration study approved by US FDA
Oncopeptides secures FDA approval to resume OPD5 clinical development
Spinogenix starts enrolment for SPG302 Phase 2 trial in schizophrenia
CRISM Therapeutics advances clinical trial for ChemoSeed
Eli Lilly reveals positive Phase two results for lepodisiran
Dupixent receives approval in Japan as first biologic for COPD treatment
Alys Pharmaceuticals doses first patient in Phase IIa trial of ALY-101
Spyre Therapeutics starts dosing in Phase 1 clinical trial of SPY003
IASO Biotherapeutics receives Macau approval for equecabtagene autoleucel NDA
Alzinova AB reports positive final Phase 1b results for ALZ-101 in Alzheimer's
Primrose Bio launches Prima RNApols ExTend RNA polymerase for long-template mRNA manufacturing