Microbial contaminations of cell banks by mycoplasma species lead to enormous production losses during production of biotechnological active substances in cell culture bioreactors.
In these processes, the reproduction and spread of mycoplasmas usually occurs undetected: mycoplasmas belong to the smallest described bacteria. With a size of 0.2 - 2 µm, they are not visible under the light microscope and they pass through conventional bacteria filters. Furthermore, during their growth in the cell culture, they do not induce the clouding of the cell culture medium typical for microbial contamination nor initiate a colour change of the medium due to a change in pH.
For initial testing of your production cell line as well as routine in-process controls, we offer a rapid test method, based on the nucleic acid amplification technique (NAT) according to Ph. Eur. 2.6.7, for investigation of mycoplasmas.
In the context of release tests, the NAT is described in the pharmacopoeias as an alternative to the traditional methods. For products with limited shelf life, e.g. ATMPs, the rapid test is the only option for the detection of mycoplasmas in a timely manner.
Product-specific validations are performed according to your requirements and in consultation with the competent authorities.
Im Februar fand im Rahmen einer Produktneuzulassung eine zweitägige...
Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
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