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Review Viral clearance for biopharmaceutical downstream ...

production process. A key aspect of risk miti - gation is to conduct viral clearance spiking studies for several downstream purification steps to demonstrate the capacity and capa-bility of the process to remove or inactivate known and unknown viruses. Contamina-tion events in biomanufacturing are rare but can be catastrophic when they occur [3,4];

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  Production, Purification

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