{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,18]],"date-time":"2026-01-18T08:14:07Z","timestamp":1768724047883,"version":"3.49.0"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,9,14]],"date-time":"2020-09-14T00:00:00Z","timestamp":1600041600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme","doi-asserted-by":"publisher","award":["PSU\u20102019"],"award-info":[{"award-number":["PSU\u20102019"]}],"id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biotech &amp; Bioengineering"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>There is growing interest in the development of new vaccines based on live\u2010attenuated viruses (LAVs) and virus\u2010like particles. The large size of these vaccines, typically 100\u2013400\u2009nm, significantly complicates the use of sterile filtration. The objectives of this study are\u00a0to examine the performance of several commercial sterile filters for filtration of a cytomegalovirus vaccine candidate (referred to as the LAV) and to develop and evaluate the use of a model nanoparticle suspension to perform a more quantitative assessment. Data obtained with a mixture of 200\u2010 and 300\u2010nm fluorescent particles provided yield and pressure profiles that captured the behavior of the viral vaccine. This included the excellent performance of the Sartorius Sartobran P filter, which provided greater than 80% yield of both the vaccine and model particles even though the average particle size was\u00a0more than 250\u2009nm. The particle yield for the Sartobran P was independent of filtrate flux above 200\u2009L\/m<jats:sup>2<\/jats:sup>\/h,\u00a0but increased with increasing particle concentration, varying from less than 10% at concentrations around 10<jats:sup>7<\/jats:sup>\u2009particles\/ml to more than 80% at concentrations above 10<jats:sup>10<\/jats:sup>\u2009particles\/ml due to saturation of particle capture\/binding sites within the filter. These results provide important insights into the factors controlling transmission and fouling during sterile filtration of large vaccine products.<\/jats:p>","DOI":"10.1002\/bit.27554","type":"journal-article","created":{"date-parts":[[2020,9,3]],"date-time":"2020-09-03T10:56:58Z","timestamp":1599130618000},"page":"106-115","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Evaluation of a sterile filtration process for viral vaccines using a model nanoparticle suspension"],"prefix":"10.1002","volume":"118","author":[{"given":"Neil","family":"Taylor","sequence":"first","affiliation":[{"name":"Department of Chemical Engineering The Pennsylvania State University  State College Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wanli","family":"Ma","sequence":"additional","affiliation":[{"name":"Vaccine Process Development Merck &amp; Co., Inc.  West Point Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Kristopeit","sequence":"additional","affiliation":[{"name":"Vaccine Process Development Merck &amp; Co., Inc.  West Point Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sheng\u2010Ching","family":"Wang","sequence":"additional","affiliation":[{"name":"Vaccine Process Development Merck &amp; Co., Inc.  West Point Pennsylvania 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  State College Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,9,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2010.05.001"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1029\/97WR00025"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biotechadv.2015.11.005"},{"issue":"8","key":"e_1_2_7_5_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1002\/biot.201800570","article-title":"Membrane\u2010based approach for the downstream processing of influenza virus\u2010like particles","volume":"14","author":"Carvalho S. B.","year":"2019","journal-title":"Biotechnology Journal"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2017.04.066"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1042\/BA20060041"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/0378-5173(94)00346-7"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1745-6584.2007.00373.x"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2016.08.016"},{"key":"e_1_2_7_11_1","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1016\/j.jconrel.2008.11.029","article-title":"Preparation of small amounts of sterile siRNA\u2010liposomes with high entrapping efficiency by dual asymmetric centrifugation (DAC)","volume":"135","author":"Hirsch M.","year":"2008","journal-title":"Journal of Controlled Release"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0150700"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2006.03.003"},{"key":"e_1_2_7_14_1","unstructured":"Kristopeit A. Konietzko J. Ma W. Phillips K. Swartz A. Wang S.\u2010C. &Tiago M.(2019).Patent No. WO 2019\/209632 A1."},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2009.01.031"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.gt.3302624"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.2134\/jeq2008.0451"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.chemrev.5b00046"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.seppur.2019.02.038"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2009.02.026"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2007.02.045"},{"key":"e_1_2_7_22_1","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1533\/9781908818638.209","volume-title":"Sterility, sterilisation and sterility assurance for pharmaceuticals","author":"Sandle T.","year":"2013"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2017.11.022"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.24798"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2016.03.067"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.20728"},{"key":"e_1_2_7_27_1","volume-title":"Global vaccine action plan 2011\u20132020","author":"WHO","year":"2011"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.memsci.2011.02.041"}],"container-title":["Biotechnology and Bioengineering"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bit.27554","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bit.27554","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bit.27554","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T20:14:02Z","timestamp":1760040842000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bit.27554"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,14]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["10.1002\/bit.27554"],"URL":"https:\/\/doi.org\/10.1002\/bit.27554","archive":["Portico"],"relation":{},"ISSN":["0006-3592","1097-0290"],"issn-type":[{"value":"0006-3592","type":"print"},{"value":"1097-0290","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,14]]},"assertion":[{"value":"2020-06-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-31","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}