Scotland-based manufacturer EnteroBiotix has announced it has been granted a Manufacturer’s licence for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The facility is set to manufacture microbiome product candidates for clinical trials and also incorporates an in-house QC hub and analytical department.
EnteroBiotix’s manufacturing capabilities include significant know-how and its novel proprietary AMPLATM platform enables 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 lyophilisation.
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
Dr 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 II 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.”
Thomson continued: “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.”
