Measuring complex, multi-strain microbiome products remains inconsistent, with biased culture assays, unclear regulatory expectations, and no validated industry standards. This workshop shows how to adopt novel assay technologies and build product-specific analytical strategies that demonstrate identity, potency, and viability, enabling confident regulatory interactions.

Workshop highlights:

• Assessing emerging technologies that quantify complex microbial consortia while capturing strain-level identity and live viability without biased culture workflows.
• Defining product-specific analytical strategies aligned with evolving FDA expectations to validate potency identity and release assays across development stages.
• Comparing approaches to measure multi-strain abundance and function including sequencing viability assays and synthetic biology readouts to strengthen mechanism claims.
• Walking through end-to-end processes for selecting labs piloting methods and validating assays to generate reproducible data satisfying regulators.