Microbiome product manufacture out of a SU facility set up
March 20 – 23, 2022
An enhanced understanding of the role the microbiome has played in health and disease over the past two decades has led to a great interest in developing Live Biotherapeutic Products (LBPs). These products contain live microbes and are intended to repair dysfunctional microbiomes, often targeting the gastrointestinal tract, but also with other targets throughout the body. SER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores designed to reduce recurrence of C. difficile infection.
The manufacturing process for SER-109 has been developed using single-use technology (SUT) extensively from initial concept for early-phase clinical development and has continued using SUT throughout the development history. In this presentation, SER-109 will be presented as a use-case for an initial product in a biotech start up environment with both internal and contract manufacturing considerations. Finally, broader perspectives will be shared on challenges facing bacterial LBP manufacture and opportunities for SUT.
Christopher McChalicher and Dave Ege, "Microbiome product manufacture out of a SU facility set up" in "Single-Use Technologies V: Building The Future", Magali Barbaroux, Sartorius, France; Martina Micheletti, University College London, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/sut_v/39