Mycoplasma

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
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.