In human health, the central and integrated role of the human gut microbiota has recently come into focus. As a result, there is a strong interest in seeking products which confer a health benefit on the host, such as probiotics (live microorganisms), prebiotics (non-living substrate selectively used by host microorganisms, conferring a health benefit) and live biotherapeutic products (LBPs, live microorganisms used to prevent or treat a disease).
Probiotics, prebiotics and LBPs are primarily developed for their benefits to gastrointestinal health, although their relevance for other sites is also being explored (e.g. oral cavity, vaginal tract and skin). One important factor to consider during probiotic/LBP development is the presence of multiple bacterial strains within a species. Critical characteristics and therapeutic effects can vary between strains, highlighting the importance of strain-specificity when considering product efficacy and safety.
BaseClear solutions for Probiotics & Live Biotherapeutics Products (LBP)
The development and validation of microbiota-management tools for probiotics and LBP’s is complex, and requires carefully designed studies to assess probiotic viability, changes in microbiome composition and function, and host benefits.
BaseClear provides standard solutions including the design and analysis of strain-specific qPCR assays, to enable detection and quantification of probiotic strains. In addition, our strain/species-level shotgun microbiome analysis framework provides a complete picture of the microbial community in the sample. Strain-specific analysis during clinical trials is essential for safe and evidence-based product development.
BaseClear can also support in strain safety assessment of LBP’s for regulatory approval. With our regulatory expertise and extensive experience in genomic analysis, we can help you answer the critical questions during product development and registration.
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