{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T14:52:38Z","timestamp":1761663158783,"version":"build-2065373602"},"reference-count":29,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2013,4,18]],"date-time":"2013-04-18T00:00:00Z","timestamp":1366243200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Biotechnology Progress"],"published-print":{"date-parts":[[2013,5]]},"abstract":"<jats:p>(1\u21923)\u2010\u03b2\u2010<jats:sc>d<\/jats:sc>\u2010Glucans (beta\u2010glucans) have been found in raw materials used in the manufacture of recombinant therapeutics. Because of their biological activity, beta\u2010glucans are considered process contaminants and consequently their level in the product needs to be controlled. Although beta\u2010glucans introduced into the cell culture process can readily be removed by bind\u2010and\u2010elute chromatography process steps, beta\u2010glucans can also be introduced into the purification process through raw materials containing beta\u2010glucans as well as leachables from filters made from cellulose. This article reports a multipronged approach to managing the beta\u2010glucan contamination in the downstream process. Raw material screening and selection can be used to effectively limit the level of beta\u2010glucan introduced into the downstream process. Placement of a cellulosic filter upstream of the last bind\u2010and\u2010elute column step or effective preuse flushing can also limit the level of contaminant introduced. More importantly, this article reports the active removal of beta\u2010glucan from the downstream process when necessary. It was discovered that the Posidyne<jats:sup>\u00ae<\/jats:sup> filter, a charge\u2010modified nylon 6,6 membrane filter, was able to effectively remove beta\u2010glucans from buffers at relatively low pH and salt concentrations. An approach of using low beta\u2010glucan buffer components combined with filtration of the buffer with a Posidyne membrane has been successfully demonstrated at preparative scale. Additionally, the feasibility of active removal of beta\u2010glucan from in\u2010process product pools by Posidyne membrane filtration has also been demonstrated. Based on the data presented, a mechanism for binding is proposed, as well as a systematic approach for sizing of the Posidyne filter. \u00a9 2013 American Institute of Chemical Engineers <jats:italic>Biotechnol. Prog<\/jats:italic>., 29:672\u2013680, 2013<\/jats:p>","DOI":"10.1002\/btpr.1718","type":"journal-article","created":{"date-parts":[[2013,4,18]],"date-time":"2013-04-18T01:47:24Z","timestamp":1366249644000},"page":"672-680","source":"Crossref","is-referenced-by-count":18,"title":["Multipronged approach to managing beta\u2010glucan contaminants in the downstream process: Control of raw materials and filtration with charge\u2010modified nylon 6,6 membrane filters"],"prefix":"10.1002","volume":"29","author":[{"given":"Eva","family":"Gefroh","sequence":"first","affiliation":[{"name":"Purification Process Development Amgen Inc. Seattle WA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Art","family":"Hewig","sequence":"additional","affiliation":[{"name":"Purification Process Development Amgen Inc. 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