VP, Technical Development Finch Therapeutics Group Somerville, Massachusetts
Title: Product Development for Microbiome Therapeutics – Concepts for a New Paradigm Abstract: Challenges in developing microbial therapeutics are as complex as those of mammalian cells. In upstream processing, most relevant strains are strict anaerobes, so the culture and processing carry additional challenges not present in more widely used cell cultures. Product delivery poses additional challenges. While most cellular therapeutics are delivered parenterally, the target for microbiome therapeutics requires either oral delivery or less desirable routes such as rectal or nasogastric delivery. To provide convenient dosing, oral delivery, typically in enteric-coated capsules, requires a dry product, not normally considered for a cellular therapy. Analytical Development Method development for microbial therapeutics is complicated not only by the complexity of cellular products generally, but by the environmental constraints that the products require for viability. Potency, typically measured as viable cell count, is more challenging for anaerobes. For a product made of bacteria, bioburden takes on a different meaning. This presentation will discuss upstream and downstream challenges and solutions.
... describe challenges in cGMP testing of microbial therapeutics.
... list several strategies to utilize microbial therapeutics.
... discuss regulatory concerns and solutions surrounding microbial therapeutics
... appreciate the challenges of oral delivery of live biotherapeutics to the GI.
... describe production requirements for anaerobic bacteria and methods of enhancing stability.