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Recent advances in understanding the relationship between the microbiota and its host have provided evidence for the therapeutic potential of certain microbes to prevent or treat disease. In the United States and Europe, live biotherapeutics (LBPs) development requires proof of quality by establishing safety, reliability, robustness, and consistency for each batch of production.
The risk of transfer of antibiotic resistance to other bacteria and the risk of causing the infection are two common risks of LBPs. These two risks (i.e., transfer of antibiotic resistance and infection) may also be associated with other risks specific to the species, the strains, and the patient who will receive the treatment. Analysis of relevant tissues using targeted qPCR along the bacterial culture direction must be performed to detect the potentially viable bacteria and demonstrate that bacteria are not translocated. If the active substance is derived from healthy human commensal bacteria that are ingested in amounts within the physiological range, and if it does not become systemically available, no additional traditional toxicity study may be necessary.
Product developers should engage in preclinical research programs that include combinations of in vitro and ex vivo models, organs-on-chips and artificial organs, all the way to in vivo models, to accumulate convincing, overlapping documentation that illustrates the global safety profile of their products adapted to the particular risks in the intended population. In general, for LBPs, as well as for all biologic drug products, safety must be considered from the very earliest stages of development, always to the target population and its clinical characteristics, as the results may influence the early selection of strains.
New assays involving microorganisms and human intestinal cells are currently being developed. Techniques like organs-on-chip and microfluidic devices containing human cells could accurately reproduce human physiology and the interactions between human cells and bacterial communities. 3D skin models or skin-on-chip technologies, combined with microfluidic culture devices, may provide new ways to assess the effects of LBP on human skin.
Caenorhabditis elegans could be a suitable model to understand whether the host, the microbe, or the environment, determines the susceptibility or resistance to infections. Immunodeficient D. melanogaster could also offer a platform to screen in vivo microbe-xenobiotic interactions, providing insight into safety outcomes potentially related to the metabolism of regular drugs by the microbiome.
Fig.1 Examples of in vitro and in vivo methods. (Chapman, 2013)
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