Virus filtration in biopharmaceutical downstream processes: key factors and current limitations

ABSTRACT

Virus clearance, a critical aspect of biopharmaceutical manufacturing processes, ensures the safety of biopharmaceutics. Virus filtration is widely used during biopharmaceutical downstream processes to remove viruses effectively by separating small viruses (e.g., parvovirus with a size of 18–26 nm) from biopharmaceutics (e.g., monoclonal antibodies with a size of ~12 nm) based on a size-exclusion mechanism (i.e., more than 4-log₁₀ removal of viruses with high product recovery). This paper presents a review of key factors such as filter morphology, feed solution composition, and the performance of high-throughput virus filtration, mainly focusing on the log reduction value for virus removal efficiency. Flow interruption and protein fouling issues are also discussed.

KEYWORDS:

• Virus filtration
• biopharmaceuticals
• downstream process
• virus clearance
• log reduction value (LRV)
• filtrate flux

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Acknowledgments

This work was supported by the Technology Innovation Program (20010914) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea). The authors would also like to thank Dr. Andrew Zydney at Pennsylvania State University for his valuable comments.

Disclosure statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

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Funding

This work was supported by the Ministry of Trade, Industry and Energy [20010914] and by INHA UNIVERSITY Research Grant [67158].