This workshop will focus on the need for standards to support the burgeoning biotech and pharma industries developing clinical applications that target the human microbiome. Informed regulatory decision making requires an understanding of the analytical performance of the assays being used to verify the identity, purity, potency and stability of these biomanufactured Live Biotherapeutic Products (LBPs).  Additionally, clinical microbiome laboratory tests must be validated before being used for donor screening, monitoring engraftment or evaluating other changes that occur in a patient’s microbiome before, during and after therapeutic intervention.

While next generation sequencing (NGS)-based (metagenomic) methods will be a major emphasis, other analytical methods, such as those being used for enumeration and viability assessment, will also be addressed.

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