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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\u00a0\u00b5m nominal pore size sterilizing grade filters with both single\u2010layer and dual\u2010layer 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\u2010selective 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.<\/jats:p>","DOI":"10.1002\/biot.202300450","type":"journal-article","created":{"date-parts":[[2024,2,25]],"date-time":"2024-02-25T21:05:43Z","timestamp":1708895143000},"source":"Crossref","is-referenced-by-count":1,"title":["Filtration of a multi\u2010serotype glycoconjugate vaccine drug product through sterilizing grade 0.2\/0.22\u00a0\u00b5m pore size filters"],"prefix":"10.1002","volume":"19","author":[{"given":"Zhuoshi","family":"Du","sequence":"first","affiliation":[{"name":"Department of Chemical Engineering The Pennsylvania State University  University Park Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Siyi","family":"Qiu","sequence":"additional","affiliation":[{"name":"Department of Chemical Engineering The Pennsylvania State University  University Park Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kanwal","family":"Gill","sequence":"additional","affiliation":[{"name":"Pharmaceutical Research and Development Pfizer Inc., 1 Burtt Rd  Andover Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vishal","family":"Toprani","sequence":"additional","affiliation":[{"name":"Pharmaceutical Research and Development Pfizer Inc., 1 Burtt Rd  Andover Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1865-9156","authenticated-orcid":false,"given":"Andrew L.","family":"Zydney","sequence":"additional","affiliation":[{"name":"Department of Chemical Engineering The Pennsylvania State University  University Park Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,25]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(84)80350-9"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2006.111500"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1128\/microbiolspec.GPP3-0019-2018"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.40.2.1127-1128.2002"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aat4615"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10719-021-09997-5"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2013.02.055"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2023.121896"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2021.119436"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2020.118797"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.28342"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.3260"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.14356\/kona.2016024"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.3180"},{"key":"e_1_2_9_16_1","article-title":"Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS\u2010CoV\u20102","author":"Kuczynski L. 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