నైరూప్య

Microbial contamination in industrial animal cell culture operations

Matthew Croughan, Sean Delfosse and Kirilynn Svay

Industrial animal cell culture is used to make many life-saving biopharmaceutical proteins, vaccines and cell therapies. Contamination of an industrial animal cell culture with a microorganism, such as a bacteria or virus, may occur through many means, for example, human error, inadequate aseptic protocols within biosafety level 2 (BSL-2) cabinets, failure of a processing step such as steam sterilization, loss of equipment integrity such as a crack in a disposable bioreactor, and/or introduction of a new adventitious agent not susceptible to current removal or inactivation procedures. The probability of having one such problem, anywhere along a linked sequence of operations (such as a batch), typically increases with the number of operations per sequence (or batch). As such, the probability of microbial (including viral) contamination typically increases with scale, as well as culture duration and/or complexity.