Viral Contamination of Biologics Manufacture—Occurrence and Mitigation

Viral contamination events are a rare occurrence in the biopharmaceutical industry. In the past, most of the reported viral contamination events have involved hamster cell production substrates. It has only been recently that we have learned about viral contaminations involving human and monkey cell production substrates. Manufacturing processes involving bacterial fermentation also are at risk of viral contamination. The viruses in this case are referred to as bacteriophage, and while these agents are not believed to represent a patient safety risk, they can wreak havoc with manufacturing processes.

Sources of viral contamination include raw materials, open vessel operations, and other less obvious sources. Small, non-enveloped viruses are the most worrisome of the viral contaminants. These may be difficult to detect, and hard to eradicate from a contaminated facility. However, risk mitigation strategies may be used to reduce the potential for contamination with these and other viruses. It is the responsibility of manufacturers to assure safety from viral contamination through raw materials (including cell banks) treatment and/or testing, process engineering, in process testing, lot release testing, and purification process validation.

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