Chapter 18 : United States Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs

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Our expanding knowledge of the nature and importance of the human microbiota has provided additional impetus to investigate the use of beneficial bacteria to promote improved health. Recent technological developments in both next-generation DNA sequencing and novel bioinformatic analyses have advanced our understanding of the nature of our microbiome and the degree to which its makeup correlates with human health and specific disease states. It is clear that the application of these technologies has the potential to inform the mechanisms of beneficial effects and to identify potentially valuable candidates for intervention. It should be noted, however, that there is a long history of the use of bacteria, initially in the form of naturally fermented foods and later by investigation of the potential roles of individual bacterial strains in disease prevention. For example, the strain Nissle 1917 was reportedly isolated about 100 years ago from a World War I soldier who, unlike his cohorts, appeared unaffected by bacterial dysentery, and it has remained a subject of study ever since ( ).

Citation: Dreher-Lesnick S, Stibitz S, Carlson P. 2018. United States Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs, p 409-416. In Britton R, Cani P (ed), Bugs as Drugs. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.BAD-0017-2017
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