Microbiological Testing of Live Biotherapeutic Products

研究和制造界需要监管工具来确定目前正在开发的新益生菌产品的身份，效力和纯度。该项目将开发鉴定这些产品的工具，特别是延senii乳杆菌和crispatus乳杆菌，这些物种是健康阴道菌群的一部分，通过使用小片段DNA编码有助于靶向这些候选物的蛋白质。通过诱导这些蛋白的表达，在产品中识别出目标物种，从而满足FDA评估所需的产品特性的监管要求之一。

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.