eBook: Key Learnings in Mycoplasma Detection for Biologics Quality Control

It is important for the safety and purity of biological products to assure that cell substrates and unprocessed bulk material used during manufacture are free of mycoplasmas. Additionally, regulatory guidelines state that cell banks and cultures used in the production of biologics must be tested for mycoplasma. This eBook will discuss the history of mycoplasma testing, commonly asked regulator’s questions within mycoplasma testing and validation and setting up in-house mycoplasma assay capabilities.

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