Process-and Product-Related Foulants in Virus Filtration

Solomon Isu, Xianghong Qian, Andrew L. Zydney, S. Ranil Wickramasinghe

Research output: Contribution to journalReview articlepeer-review

6 Scopus citations

Abstract

Regulatory authorities place stringent guidelines on the removal of contaminants during the manufacture of biopharmaceutical products. Monoclonal antibodies, Fc-fusion proteins, and other mammalian cell-derived biotherapeutics are heterogeneous molecules that are validated based on the production process and not on molecular homogeneity. Validation of clearance of potential contami-nation by viruses is a major challenge during the downstream purification of these therapeutics. Virus filtration is a single-use, size-based separation process in which the contaminating virus particles are retained while the therapeutic molecules pass through the membrane pores. Virus filtration is routinely used as part of the overall virus clearance strategy. Compromised performance of virus filters due to membrane fouling, low throughput and reduced viral clearance, is of considerable industrial significance and is frequently a major challenge. This review shows how components generated during cell culture, contaminants, and product variants can affect virus filtration of mammalian cell-derived biologics. Cell culture-derived foulants include host cell proteins, proteases, and endotoxins. We also provide mitigation measures for each potential foulant.

Original languageEnglish (US)
Article number155
JournalBioengineering
Volume9
Issue number4
DOIs
StatePublished - Apr 2022

All Science Journal Classification (ASJC) codes

  • Bioengineering

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