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WHITEPAPERS

Overcoming challenges associated with USP <61>( Microbial Enumeration) and USP <62> ( Specified Microorganism) Testing of Microbiome Based Therapeutic Products

Expanding research into the microbiome has revealed how important this complex community of microbes and their genes are. We’ve also discovered how intricately connected the microbiome and human health are. Leveraging the knowledge obtained from microbiome research into therapeutic products offers an exciting new approach to treating multiple disease indications and improving human health. Before these products can be manufactured and distributed widely for use, several hurdles including microbial testing must be overcome. The purpose of these tests is to confirm the total microbial count is within specification and free from pathogens. Microbiome based therapeutic products are complex in nature and origin, leading to similarly complex characterization schemas. In order to develop an effective microbial characterization plan for a product, you want to look at several considerations:

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