Live Biotherapeutic Products (IMAGE)

Pharmabiotic Research Institute (PRI)

Live Biotherapeutic Products

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European regulatory expertise centre, the Pharmabiotic Research Institute (PRI), which supports the pharmaceutical development of microbiome-based drug products, stemming from a new field of biological medicine, has published a review of the regulatory and scientific requirements needed to properly develop live biotherapeutic products (LBPs). Similarly to other innovative medicinal products, demonstrating the quality, efficacy and safety of these living medicines will require an innovative regulatory and technical approach.

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Pharmabiotic Research Institute (PRI)

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