A new white paper, “Advanced Detection of Mycoplasmas: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers,” explores relevant mycoplasma characteristics, established testing solutions, and the use of real-time PCR analysis as an alternative testing method for fast, preliminary mycoplasma detection.
“Of all the threats that keep quality managers awake at night, mycoplasmas rank high. In a career performing quality control or quality assurance for biopharmaceutical manufacturing anywhere in the world, a QC or QA specialist will probably encounter mycoplasma contamination of a production facility at least once. The resulting devastation to the site’s output and schedules, as well as to its staff’s peace of mind, makes it urgent to avoid any repetition of the experience,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories, a leader in biopharmaceutical and mycoplasma tests and services.
“Whereas the traditional direct cultivation method takes 28 days to provide results, modern real-time PCR mycoplasma tests and analysis in an experienced testing laboratory may be accomplished in an actual testing duration of only 24 hours, plus the time needed for sample collection, shipment, preparation, and handling,” he said.
The white paper identifies the shortcomings of traditional identification methods, such as direct culture (for cultivable species), indirect culture (DNA fluorochrome staining — for noncultivable species), DNA probe, PCR, enzyme-linked immunosorbent assay (ELISA), autoradiography, and immunofluorescence.
The white paper explains how, as opposed to traditional methods, PCR mycoplasma analysis accurately quantifies DNA and/or RNA, furnishes increased sensitivity and specificity, detects all known mycoplasma species and works whether mycoplasmas in sample are living or dead.