A cause of cell culture contamination that present problems in cell cultures and is difficult to diagnose. Capable of passing through 0.2um pore size filters. Read more details
Reference | Title | Description |
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Barile (Large Volume) | Isolation of Mycoplasma arginine from Commercial Bovine Sera and Its Implication in Contaminated Cell Cultures | Barile, MF and Kern J (1971) Proc. Soc. Exp. Biol. 138:432-7 Mycoplasma testing of sera, media, and bioproduct by direct culture method described by Large Volume Barile Method. |
21CFR 610.30 | General Biologicals Products Standards – Mycoplasma | Test is satisfactory for vaccine manufacture if none of the tests on the samples show evidence of the presence of Mycoplasma. Specific to live and inactivated viral vaccines |
9CFR 113.28 | Detection of viable bacteria and fungi except in live vaccine | If no growth is found in any test vessel, the serial or subserial meets the requirements of the test. |
9CFR 113.24 | Detection of extraneous viable bacteria and fungi in live vaccines | No extraneous growth found |
GMP | Real Time PCR | Real-Time polymerase chain reaction (PCR) for detection of Mollicutes species. |
EP 2.6.2 | Mycobacteria | At the end of the incubation time no growth of mycobacteria occurs in any of the test media, the preparation complies with the test. |
USP <63> | Mycoplasma Test: A new Regulation for Mycoplasma Testing | The product complies with the test if growth of typical Mycoplasma colonies has not occurred. |
JP Mycoplasma | Mycoplasma Testing for cell substrates used for the production of biotechnological/Biological products | Detection of mycoplasma should be evaluated, and detection limit determined and validated. |