Microbiome therapeutics company, EnteroBiotix Limited has been granted a manufacturer’s license for a GMP manufacturing facility for Investigational Medicinal Products (IMP) to make microbiome product candidates for clinical trials.
It was given by the Medicines and Healthcare Products Regulatory Agency (MHRA) and also incorporates an in-house QC hub and analytical department.
EnteroBiotix’s manufacturing capabilities include its AMPLA platform that enables the rapid preparation of dry powder from hydrated starting material at static temperature.
This technology has potential applicability across the entire spectrum of microbiome therapies that are currently dried using traditional methods, including lyophilization.
James McIlroy, CEO at EnteroBiotix, said: “I am thrilled that we have achieved this significant step in our journey towards transforming the standard of care for patients around the world through using best-in-class full-spectrum microbial therapeutics.
“Our MHRA licensed facility will support the high quality, safe, and consistent manufacturing of our products. I look forward to initiating a phase 2 clinical trial for our lead microbiome therapeutic asset, EBX-102, in patients with liver cirrhosis.”
Douglas Thomson, non-executive chairman at EnteroBiotix, said: “Manufacturing is a well-known bottleneck for the development of microbial therapeutics. The board has backed the vision of establishing control of the supply chain and to develop in-house manufacturing and analytical capabilities as a strategic asset.
“With the capability to manufacture, scale, and characterise product candidates, EnteroBiotix is well positioned to accelerate the development of its product pipeline for the benefit of patients. I am proud to have supported the EnteroBiotix team in achieving another significant milestone.”
EnteroBiotix’s facilities are headquartered in Scotland’s Strathclyde Business Park. The company says the GMP-certified manufacturing facility is the most advanced of its kind in Europe. It is designed to operate as a flexible and scalable manufacturing hub, underpinning the company’s therapeutic pipeline and providing end-to-end control of the supply chain.