Filtration of a multi-serotype glycoconjugate vaccine drug product through sterilizing grade 0.2/0.22 µm pore size filters

Zhuoshi Du, Siyi Qiu, Kanwal Gill, Vishal Toprani, Andrew L. Zydney

Research output: Contribution to journalArticlepeer-review


Glycoconjugate vaccines containing multiple serotypes of a bacterial capsular polysaccharide can provide strong immune protection against pathogenic infections. Sterile filtration is an important component of the fill and finish operations in the preparation of these vaccines, with the capacity of the sterile filter limited by membrane fouling. The objective of this study was to examine the performance of a range of commercial 0.2/0.22 µm nominal pore size sterilizing grade filters with both single-layer and dual-layer structures during filtration of a glycoconjugate vaccine drug product consisting of four polysaccharide serotypes. The highly asymmetric Millipore Express showed much higher capacity than the more homogeneous filters, with the support structure of the Express acting as a prefilter that was able to remove foulants thereby protecting the small pores in the size-selective skin layer. This behavior was confirmed by performing experiments with different batch prefilters and by examining the location of foulant deposition within the sterile filters using confocal microscopy. These results provide important insights into the factors controlling fouling by these multiserotype vaccines as well as a framework for increasing the capacity of the sterile filter.

Original languageEnglish (US)
Article number2300450
JournalBiotechnology Journal
Issue number2
StatePublished - Feb 2024

All Science Journal Classification (ASJC) codes

  • Applied Microbiology and Biotechnology
  • Molecular Medicine

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