Microbiological Attributes, Specifications, and Risk Assessment of Culture-Based Therapeutic Products

摘要

A major challenge with emerging heterogeneous, live culture-based products Is setting consistent, risk-based microbial specifications to protect the recipients of these product from potential microbial infection. A review of the literature and the published regulatory requirements demonstrates a lack of consensus as to donor and/or product infectious disease screening that may inevitably harm patients along with increased costs and delayed product availability. This review article addresses the microbiological attributes, specifications, screening methods, and risk assessment of these unique products and makes recommendations as to the path forward.