“GENUINE CULTURES”

PASSAGE #, GENITIC DRIFT, MUTATIONS, PURITY OF CULTURE, SAMENESS OR CONTAMINATION

My argument concerns the use of microorganisms for pharmaceutical industry testing, including growth promotion tests, preservative efficacy testing, antibiotic effectiveness testing and food processing testing. All these tests are required to help determine a given product’s ability to withstand challenges in a “ real world environment” .

The real world situation, as we know, does not involve a single strain, less than three passages as a pure culture, with no mutations or genetic drift . The microbial world and its environments do not adhere to such rules, as can be observed in the drama of real life. It is puzzling to me why the USP, AOAC/CTFA and other publications, as well as articles in scientific literature, continue to promote these very inconsistencies, to support the use of only ATCC strains, and to ignore the artificiality of the constraints imposed by commercial bureaucracies.

I believe that most microorganisms existed in one form or another, long before mankind or ATCC ever was created. One can ask if our primitive ancestors had the same microorganisms that afflict us today; and if so, surely the bugs were not constrained to a passage number less than three or five, nor have they been free from mutations or subjection to genetic drift. So why is it so important to adhere to some artificial and nonsensical standards that have no meaning in real life? In most pharmaceutical microbiology texts that discuss the importance of obtaining environmental isolates, emphasis is placed on storage and maintenance so that the original characteristics are not lost and the variability is preserved. As a matter of fact, most recommend that microorganisms between passages or growth on artificial medium should be maintained in an environment comparable to the environment they came from.

In case of pathogens, it’s a known fact that organisms cultured under laboratory conditions eventually lose or diminish their virulence or their ability to infect; this property indeed provides the basis for vaccine development. Further, people working in this field know well that one has to regularly passage an organism through an animal model in order to maintain its infectivity/virulence/pathogenic properties.

On the other hand, perhaps the reason highly esteemed institutions like ATTC openly ignore science by using such terms is primarily to gain or maintain market share for their products.