Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management
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 microbiology plating-based procedur...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-07-01
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| Series: | Frontiers in Microbiology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmicb.2021.693066/full |
| _version_ | 1818733544741011456 |
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| author | M. L. Jane Weitzel M. L. Jane Weitzel Christina S. Vegge Marco Pane Virginia S. Goldman Binu Koshy Cisse Hedegaard Porsby Pierre Burguière Jean L. Schoeni |
| author_facet | M. L. Jane Weitzel M. L. Jane Weitzel Christina S. Vegge Marco Pane Virginia S. Goldman Binu Koshy Cisse Hedegaard Porsby Pierre Burguière Jean L. Schoeni |
| author_sort | M. L. Jane Weitzel |
| collection | DOAJ |
| description | 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 microbiology plating-based procedures, yielding results in colony-forming units (CFU). One drawback to plating-based procedures is high variability due to intrinsic and extrinsic uncertainties. These uncertainties make comparison between analytical procedures challenging. In this article, we provide tools to reduce measurement uncertainty and strengthen the reliability of probiotic enumerations by using analytical procedure lifecycle management (APLM). APLM is a tool that uses a step-by-step process to define procedure performance based on the concept that the reportable value (final CFU result) must be fit for its intended use. Once the procedure performance is defined, the information gathered through APLM can be used to evaluate and compare procedures. Here, we discuss the theory behind applying APLM and give practical information about its application to CFU enumeration procedures for probiotics using a simulated example and data set. Data collected in a manufacturer’s development laboratory is included to support application of the concept. Implementation of APLM can lead to reduced variability by identifying specific factors (e.g., the dilution step) with significant impact on the variability and providing insights to procedural modifications that lead to process improvement. Understanding and control of the analytical procedure is improved by using these tools. The probiotics industry can confidently apply the information and analytical results generated to make decisions about processes and formulation, including overage requirements. One benefit of this approach is that companies can reduce overage costs. More reliable procedures for viable cell count determinations will improve the quality evaluation of probiotic products, and hence manufacturing procedures, while ensuring that products deliver clinically demonstrated beneficial doses. |
| first_indexed | 2024-12-17T23:51:09Z |
| format | Article |
| id | doaj.art-9d9aec8a1fbe445c87eb49b4a607fa9e |
| institution | Directory Open Access Journal |
| issn | 1664-302X |
| language | English |
| last_indexed | 2024-12-17T23:51:09Z |
| publishDate | 2021-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Microbiology |
| spelling | doaj.art-9d9aec8a1fbe445c87eb49b4a607fa9e2022-12-21T21:28:12ZengFrontiers Media S.A.Frontiers in Microbiology1664-302X2021-07-011210.3389/fmicb.2021.693066693066Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle ManagementM. L. Jane Weitzel0M. L. Jane Weitzel1Christina S. Vegge2Marco Pane3Virginia S. Goldman4Binu Koshy5Cisse Hedegaard Porsby6Pierre Burguière7Jean L. Schoeni8Expert Committee on Measurement and Data Quality, US Pharmacopeial Convention, Rockville, MD, United StatesIndependent Consultant, Winnipeg, MB, CanadaAnalytical Development, Bacthera, Hørsholm, DenmarkProbiotical Research Srl, Novara, ItalyScience Division, Department of Dietary Supplements and Herbal Medicines, US Pharmacopeial Convention, Rockville, MD, United StatesScience Division, Department of Dietary Supplements and Herbal Medicines, US Pharmacopeial Convention, Rockville, MD, United StatesAnalytical Development, Bacthera, Hørsholm, DenmarkAdvanced Microbial Analytics (AMA) Research Solutions, Lyon, FranceEurofins Microbiology Laboratory, Madison, WI, United StatesProbiotics 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 microbiology plating-based procedures, yielding results in colony-forming units (CFU). One drawback to plating-based procedures is high variability due to intrinsic and extrinsic uncertainties. These uncertainties make comparison between analytical procedures challenging. In this article, we provide tools to reduce measurement uncertainty and strengthen the reliability of probiotic enumerations by using analytical procedure lifecycle management (APLM). APLM is a tool that uses a step-by-step process to define procedure performance based on the concept that the reportable value (final CFU result) must be fit for its intended use. Once the procedure performance is defined, the information gathered through APLM can be used to evaluate and compare procedures. Here, we discuss the theory behind applying APLM and give practical information about its application to CFU enumeration procedures for probiotics using a simulated example and data set. Data collected in a manufacturer’s development laboratory is included to support application of the concept. Implementation of APLM can lead to reduced variability by identifying specific factors (e.g., the dilution step) with significant impact on the variability and providing insights to procedural modifications that lead to process improvement. Understanding and control of the analytical procedure is improved by using these tools. The probiotics industry can confidently apply the information and analytical results generated to make decisions about processes and formulation, including overage requirements. One benefit of this approach is that companies can reduce overage costs. More reliable procedures for viable cell count determinations will improve the quality evaluation of probiotic products, and hence manufacturing procedures, while ensuring that products deliver clinically demonstrated beneficial doses.https://www.frontiersin.org/articles/10.3389/fmicb.2021.693066/fullprobioticsUSPcolony-forming unitsenumerationanalytical procedure lifecycle managementanalytical target profile |
| spellingShingle | M. L. Jane Weitzel M. L. Jane Weitzel Christina S. Vegge Marco Pane Virginia S. Goldman Binu Koshy Cisse Hedegaard Porsby Pierre Burguière Jean L. Schoeni Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management Frontiers in Microbiology probiotics USP colony-forming units enumeration analytical procedure lifecycle management analytical target profile |
| title | Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management |
| title_full | Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management |
| title_fullStr | Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management |
| title_full_unstemmed | Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management |
| title_short | Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management |
| title_sort | improving and comparing probiotic plate count methods by analytical procedure lifecycle management |
| topic | probiotics USP colony-forming units enumeration analytical procedure lifecycle management analytical target profile |
| url | https://www.frontiersin.org/articles/10.3389/fmicb.2021.693066/full |
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