Three leading British biotechnology businesses have obtained grant funding from Innovate UK to investigate the manufacture of a new class of medicines, targeting a range of clinical conditions through interaction with the human microbiome.
The novel and highly innovative approach is to use spores derived from anaerobic bacteria (Clostridia) that are naturally found in the large intestine to deliver targeted anti-inflammatory therapeutics. Bacterial spores are resistant to acid, so when ingested in a tablet or capsule, they are able to pass largely unscathed through the stomach before germinating and releasing the anti-inflammatory bio-actives (payload) to where it is needed in the colon, to treat chronic and debilitating inflammatory conditions, such as ulcerative colitis and Crohn’s Disease.
The concept has been proven in pre-clinical tests by the project consortium lead CHAIN Biotechnology, but until now a stumbling block has been the lack of a biopharmaceutical manufacturing facility in the UK, able to scale-up and manufacture clostridial spore-based medicines to the required standard following good manufacturing practice (GMP) needed for medicinal products for human testing and use.
This is where Porton Biopharma with its knowledge and history of developing and producing bio-therapeutics from various spore-forming bacteria, and Scitech, which specialises in design, engineering, construction and validation of facilities within the life-science sector will add their expertise.
Developing and testing the technological approach of microbiome targeted therapeutics, and being first in the market with an advanced medicine manufacturing capability and capacity required for such products, would see CHAIN Biotechnology and the UK taking a step closer to becoming world-leaders in this fast growing emerging health care area.
Dr Basil Omar CHAIN’s Co-Founder and Chief Commercial Officer said “The output of this feasibility project will support the business case for further investment in a dedicated advanced manufacturing facility for these breakthrough therapeutic products offering medical treatments and delivering real benefits for long-suffering patients”.
Dr Roger Hinton MD of Porton Biopharma said “This is an ideal fit for us given our history of developing biopharmaceuticals from spore formers, knowledge of GMP manufacture and specialised containment microbiology. We are very excited by the commercial potential”.
Dave Grant MD of Scitech said “Life sciences are an essential part of the UK Government’s new industrial strategy and this award facilitates the creation of much needed new specialist manufacturing industrial infrastructure with new highly-skilled jobs”.