Equivalence of Quality Control Strains of Microorganisms Used in the Compendial Microbiological Tests: Are National Culture Collection Strains Identical?

Abstract

The pharmacopoeias list a number of microorganisms to be used in the compendial microbiological tests for confirming the growth-promoting, indicative, and inhibitory properties of the media and demonstrating the suitability of the test for a specific test article. Major national culture collections are specified as the sources for these test strains based on their history of deposition and maintenance and use in the compendial tests. Using these microorganisms, it has long been assumed that these strains are interchangeable and that sourcing the strains from different culture collections has no impact on the result of the media quality control and method qualification tests. In order to evaluate whether this assumption is correct and to add more certainty to the procedures, we investigated whether there are detectable differences among isolates of the same strain sourced from different culture collections. Using various phenotypic and genotypic identification and strain typing methods, nine major pharmacopoeial species were analyzed. As expected, most of the species showed very uniform patterns across the isolates, indicating that the strains were indeed identical. Surprisingly, the strains of Salmonella enterica subsp. enterica serotype abony showed distinct differences at both the genotypic and the phenotypic level, suggesting that the strains sourced from the different culture collections were not identical strains, or that they have undergone detectable genetic shift from the time they were derived from the original depositor. Irrespective of the level of genotypic or phenotypic homology identified here, there are no practical consequences on their performance in compendial assays. It is concluded that the compendial strains investigated in this study are indeed equivalent and will perform identically in compendial tests, making it safe to base pharmaceutical quality control procedures on the strains sourced from any of the recognized national culture collections.