Microbiotica to present positive update on manufacturing progress of its live biotherapeutic products
Cambridge, UK – 9 July 2024: Microbiotica, a biopharma company developing a pipeline of orally-delivered precision microbiome medicines called live biotherapeutic products (LBPs), announces that Adam Wilkinson, its Vice President of Pre-Clinical Development, will present an overview of the company’s successful product manufacturing campaigns ahead of its forthcoming melanoma and ulcerative colitis clinical studies at the 9th Microbiome Movement Drug Development Summit, on 11 July, in Boston, USA, together with Claire Derlot, CBO from its GMP manufacturing partner Biose Industrie.
Microbiotica is a leading company developing LBPs based on the gut microbiome. Its lead programs, MB097 for advanced melanoma and MB310 for ulcerative colitis are on track to enter clinical studies this year. In preparation, to scale processes for the production of cGMP-compliant clinical trial batches, Microbiotica entered into a manufacturing contract with Biose Industrie, a world-leading CDMO for microbiome therapeutics.
Each of Microbiotica’s LBPs comprise defined consortia of multiple bacterial strains, identified using its precision microbiome discovery platform which analyses the gut microbiome composition of patients and identifies bacterial species associated with clinical response. Manufacturing processes are developed for each individual bacterium, resulting in the production of freeze-dried stable powders which are combined into bespoke capsules for oral dosing.
Microbiotica has established expertise in the isolation and culturing of novel bacteria from the human gut microbiome, which it has leveraged, together with GMP manufacturing partner Biose, in the development of robust GMP manufacturing processes to produce batches for their multi-strain LBPs. Biose has provided its knowledge and experience in the industrialisation of bacterial manufacturing processes to scale up the growth of these therapeutic bacteria, preserving them in stable freeze-dried state. GMP manufacturing processes for both programs have been developed at Biose.
“Working in partnership with the Biose team, we are delighted to have successfully navigated the challenges of process development and scale-up of two LBPs in parallel. Manufacturing of biologics can be challenging at the best of times, but the development of multiple processes to be scaled up to cGMP standard poses significant challenges, and seamless open collaboration between our project teams has been essential to success,” said Adam Wilkinson, Vice President of Pre-Clinical Development at Microbiotica.
Tim Sharpington, Microbiotica’s CEO, added, “Adam and his team, together with the Biose team, have done an amazing job to ensure that we are ready to start both of our clinical trials in the second half of this year. These first-in-patient trials will be a major milestone for the company.”
Microbiotica has a clinic-led, purpose-built, proprietary, microbiome profiling platform to support drug discovery based on clinical data, which enables precision identification of bacteria associated with favourable clinical trial outcomes in specific patient populations. The company has significant expertise in microbiology, bioinformatics, translational biology and LBP manufacturing and development.
