USP Open Forum: Comparing Probiotic Plate Count Methods

Event summary Agenda  Speaker biographies

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Probiotics are live microorganisms that confer a health benefit to the host when administered in adequate amounts. This definition links probiotic efficacy to microbial viability. The current gold standard assay for probiotic potency is enumeration using classical microbiological plating-based procedures, yielding results in colony-forming units (CFU).

There have been numerous clinical trials on individual strains of probiotics, often leading to strain-specific claims. Dosage of live cells is an important factor (“adequate amount”) in clinical trials. The majority of clinical trials to date are based on CFU. One drawback to plating-based procedures is high variability due to intrinsic and extrinsic uncertainties. These uncertainties make comparison between analytical procedures challenging. Therefore, a means to reduce variation is needed to obtain accurate CFU counts of probiotic ingredients and products.

The United States Pharmacopeia (USP) held an Open Forum on comparing probiotic plate count methods to obtain input from stakeholders on this topic. The event introduced USP’s approach to probiotic enumeration method and provided tool(s) for qualifying and comparing different CFU enumeration procedures.   

The interactive Open Forum was held virtually on Thursday, June 16, from 10:00 a.m. – 12:30 p.m. Eastern Daylight Time.

Topics covered

  • USPs’ approach to probiotic enumeration
  • Analytical procedure life cycle management (APLM) for CFU enumeration of probiotics
  • Validation/Verification parameters for APLM
  • Comparing CFU enumeration method using Tolerance Interval

Who participated?

Ingredient manufacturers, supplement manufacturers, QC managers, QC staff scientists, research scientists, and QA staff.

Event Summary

Coming Soon

Event Presentations

  1. USP Approach to Probiotic Enumeration, Dr. Christina Vegge, Probiotic Expert Panel Member
  2. <1220> Analytical Procedure Life Cycle Management (APLM) for CFU Enumeration of Probiotics, Dr. Christina Vegge, Probiotic Expert Panel Member
  3. Comparing Probiotic Plate Count Methods by APLM, Ms. Jane Weitzel, Chair, Measurement and Data Quality Expert Committee

For further information, please get in touch with Jacqueline D. Starkes.

 

Teleconference