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Mycoplasma Testing – PCR & Traditional

Mycoplasma are classified as a genus of bacteria that have no cell walls and consist of over 120 species.  Mycoplasma are pathogenic, cannot be gram stained, and are the smallest bacterial cells discovered.  These bacteria are often unaffected by antibiotics and frequently linked to several types of cancers.

Mycoplasma testing is a necessary quality control requirement to certify that dependable research is performed and to ensure that the biotechnology products produced are reliable.

Applicable Standards

  • United States Pharmacopeia (USP) <63>
  • European Pharmacopeia (EP) General Chapter 2.6.7
  • Japanese Pharmacopeia (JP)
  • 9 CFR 113.28
  • 21 CFR 610.30
  • PCR (polymerase chain reaction)

Testing Locations

  • Salt Lake City, UT, USA

Learn more about our locations and their certifications.

Study Outline

The USP <63> Mycoplasma Testing chapter describes two methods to detect mycoplasma.  The first is an agar and broth media procedure and the second is an indicator cell culture procedure.  The mycoplasma species suitable for use in USP <63> Mycoplasma Testing chapter are:

  • Acholeplasma laidlawii (vaccines and/or cell-derived materials/cultures for human and veterinary use when an antibiotic has been used during production)
  • gallisepticum (when avian material has been used during production or when the vaccine or cell culture is intended for use in poultry)
  • hyorhinis (nonavian veterinary vaccines or cell cultures)
  • orale (vaccines for human and veterinary use)
  • pneumoniae (vaccines or cell banks for human use) or another suitable species of D-glucose fermenter such as M. fermentans
  • synoviae (when avian material has been used during production or when the vaccine or cell bank is intended for use in poultry)

When performing PCR mycoplasma testing there are theoretically 60 strains that can be detected from a test article or sample.  Due to the nature of some components in samples, an initial suitability test is recommended to verify whether these contain substances inhibitory to PCR.

If you have additional questions about Mycoplasma Testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.

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