Application Note | October 17, 2012

Minimizing The Risk Of Mycoplasma Contamination During Mammalian Cell Culture

Source: Parker domnick hunter Process Filtration

A mycoplasma contamination event can have a major harmful impact on a biopharmaceutical manufacturer. The loss of a cell culture due to a contamination incurs significant costs that can be attributed to both the initial bioreactor set-up and to the subsequent decontamination. Production facility throughput and, in the worst cases, the ability of the manufacturer to supply patients with medicines may be affected.

Mycoplasma are extremely small in size and lack a cell wall giving the cells some flexibility that enables them to penetrate the 0.2 micron filters used to ‘sterilize’ cell culture media. The filtration of cell culture media with 0.1 micron filters alongside the effective screening of cell lines for infection and adherence to GMP principles of contamination control will minimize the risk of bioreactor contamination.

The culture of mammalian cells is a key technology used in the manufacture of biopharmaceuticals. Microbial contamination of cell cultures is a major cause of lost production batches with significant economic impact for the manufacturer. The risk of contamination can be controlled by ensuring all components entering the bioreactor are free from microorganisms. Media used for the culture of mammalian cells commonly contains heat-labile components and consequently cannot be sterilized at high temperatures. Filtration through a sterilizing grade, 0.2 micron filter can protect mammalian cell cultures from contamination by many microorganisms but does not protect against contamination by mycoplasma species.

 

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Parker domnick hunter Process Filtration