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Feedback from Seres Therapeutics, Inc. - Lessons Learnt from Microbiome Therapeutics in Clinical Development
Seres Therapeutics, Inc.
Designing Scale Up and Manufacturing Processes for Microbiome Therapeutics
Vedanta Biosciences, Inc.
Lessons Learnt from Microbiome Therapeutics in Clinical Development
The presentation will address the challenges in the design and evaluation of clinical trials of microbiome therapeutics. Main points to be covered include:
Regulatory Pathways for Microbiome Therapeutics
Research and business around the microbiome continues to rapidly expand. There are currently many institutions and companies looking at various ways to utilize bugs as drugs. More science and quality parameters are being developed to create, manufacture and commercialize these new and unique medicines to treat various diseases of the microbiome Microbiota Restoration Therapy (MRT) is one example of a new and novel way to provide bugs as drugs utilizing Science and Quality.
Overcoming Scale Up, Manufacturing and Formulation Challenges
Live Biotherapeutic Products (LBPs) have great potential to treat diseases related to the dysbiosis of the gut microbiota. Designing scale up processes for LBPs presents its own unique challenges. This presentation will discuss the considerations necessary when performing process development, scale up, and manufacturing for multiple anaerobic microbial cultures for a rationally designed CGMP LBP.
German authorities classify fecal microbiota transfer (FMT) products as drugs to be manufactured in a GMP facility, regulated under the German Medicines Act. The University Hospital Cologne is creating a GMP-certified national stool bank to assure supply with high quality FMT products for the purpose of clinical care and clinical trials.
Commercialisation of Microbiome Therapeutics
Human milk has been the sole source of nutrition for infants for millions of years, and is rich in specific oligosaccharides (HMOs). The natural infant gut microbiome is dominated by a single species of Bifidobacteria that is exceptionally competitive at consuming HMOs. Through the unintended consequences of formula feeding, antibiotic use, and C-Section deliveries, a keystone commensal in this natural microbiome has been lost in the developed world. We have rescued the natural microbiome from the present dysbiosis through an early remodeling that returns the colonic microenvironment to its natural state.