ANALYTICAL METHOD FOR QUANITIFICATION OF VIABLE BACTERIA CONTAINED IN MICROBIOTA RESTORATION THERAPY (MRT) COMPOSITIONS

摘要

Quantification of the viable bacterial microorganisms in a drug product for delivery via a gastro-nasal tube, an enema and/or a capsule or tablet. A molecular-based approach, such as PMA (propidium monazide)-qPCR (quantitative polymerase chain reaction) assays may be useful for quantification of viable bacteria. By utilizing PMA treatment in combination with qPCR, the number of viable bacterial cells in the sample can be determined.