Mycoplasmas pose a high risk for active substances produced biotechnologically in cell culture bioreactors. Microbial contamination of cell banks through mycoplasma leads to enormous production losses.
Usually the multiplication and spread of mycoplasma goes undetected: mycoplasma belong to the smallest described bacteria. With a size of 0.2–2 µm, they are not visible under the light microscope and pass through conventional bacteria filters. Furthermore, they do not create clouding of the cell culture medium, which is typical for microbial contamination, during their growth, nor do they cause a colour change due to a change in pH value.
We offer a rapid test for detecting mycoplasma both for initial testing of your production line as well as for regular in-process control. The test is based on the nucleic acid amplification technique (NAT) according to Ph. Eur. 2.6.7. The rapid test is described as an alternative to the classical methods in the pharmacopoeias as part of release tests. For products with a low shelf life, e.g. ATMPs, the rapid test is the only option for detecting mycoplasma in a timely manner.
We are pleased to help our customers with product-specific validations as well as taking into account the requirements of the competent authorities.