Microbiological Testing of Live Biotherapeutic Products

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The research and manufacturing community has a need for regulatory tools to determine the identity, potency, and purity of new probiotic products currently under development. This project will develop tools for identifying these products, specifically Lactobacillus jensenii, and Lactobacillus crispatus, the species that are part of the healthy vaginal flora, by using small pieces of DNA to code for proteins that will help target these candidates. By inducing the expression of these proteins, the target species are identified in the product therefore satisfying one of the regulatory requirements for product characterization needed by the FDA for evaluation.