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Modification of Virus Spiking Procedures for Continuous Processes

This white paper demonstrates the feasibility of novel virus spiking strategies to meet the needs of continuous processes.

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Released By MilliporeSigma

Virus safety strategies are well-defined and applied throughout the biomanufacturing workflow. Essential steps include preventing contaminants from entering the process by testing raw materials, including cell lines used to produce recombinant proteins; detecting potential contaminants at various places throughout the process; and removing and inactivating viruses
through viral clearance steps.
 
Evaluating viral clearance for traditional batch processes has a long track history and, in most cases, is relatively straightforward. A small-scale model of an individual step is developed and verified to be an appropriate representation of the full-scale process. The process load for that step is spiked with virus and the output from the step, containing the product, is tested for virus. Clearance across each step is the difference between the amount of virus in the product containing output fraction, compared to the amount spiked in the load, and is usually expressed in logs.

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