title: The scope of mycoplasma contamination within the biopharmaceutical industry.
abstract: Mycoplasma is well recognized as one of the most prevalent and serious microbial contaminants encountered within the manufacturing of biopharmaceuticals from the research phase to clinical development and production. The potential for mycoplasma contamination within cell culture systems was first identified by Robinson et al. in 1956. Presently, contamination rates in established cell cultures have been reported between 15 and 35% with considerably higher occurrence cited in certain selected populations. In the last few years, there has been an expansion of diagnostic approaches for mycoplasma detection with the development and validation of rapid microbiological methods. The objective of this study was to determine current levels of mycoplasma infection of cell cultures, cell substrates and biologicals within a client based population. Retrospective comparison of 40,000 sample results was done to determine total contaminations rates amongst four (4) individual analytical assays. The establishment of reference data, such as existing contamination rates, becomes important in the critical appraisal of rapid microbiological methods for the detection of mycoplasma.
authors.affiliation: Bionique Testing Laboratories, Inc., 156 Fay Brook Drive, Saranac Lake, NY 12983, USA. sarmstrong@bionique.com
authors.forename: Shayn E
authors.initials: SE
authors.lastname: Armstrong
authors.forename: Jill A
authors.initials: JA
authors.lastname: Mariano
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lundin
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards; D001702:Biopharmaceutics / Q000592:standards* / Q000706:statistics & numerical data; D002478:Cells, Cultured; D015331:Cohort Studies; D003470:Culture Media / Q000032:analysis; D004269:DNA, Bacterial / Q000032:analysis / Q000302:isolation & purification; D004340:Drug Contamination / Q000706:statistics & numerical data*; D004345:Drug Industry / Q000592:standards* / Q000706:statistics & numerical data; D005453:Fluorescence; D006801:Humans; D008420:Manufactured Materials / Q000382:microbiology* / Q000592:standards / Q000706:statistics & numerical data; D008828:Microbiological Techniques / Q000706:statistics & numerical data; D009174:Mycoplasma / Q000235:genetics / Q000302:isolation & purification* / Q000502:physiology; D009175:Mycoplasma Infections / Q000453:epidemiology; D012189:Retrospective Studies
chemical_list: D001688:Biological Products; D003470:Culture Media; D004269:DNA, Bacterial