The technology of dual-labeled hydrolysis probes (also called TaqMan® real-time PCR probes) exploits the 5 ́-3 ́ exonuclease activity of Taq DNA polymerase to cleave the probe. TaqMan real-time PCR probes are labeled with a fluorescent dye (reporter) at the 5´ end and with a quencher at the 3´ end.
Mycoplasma contaminants may be introduced into cell culture and other biological products through master seeds, master cell seed (stock), starting materials of animal origin, and in processing of biological materials during passage and product assembly. It is therefore necessary to demonstrate through testing that Mycoplasma is not present in the final product, working seeds and cells and harvests, and starting materials such as master seed, master cell seed, and ingredients of animal origin.
The test is done in compliance with Europe pharmacopeia test 2.6.7.