title: A tool for increasing the lifetime of chromatography resins.
abstract: There is a steadily increasing demand for speed, cost efficiency, and process understanding within biopharmaceutical process development. To match this, a high-throughput method for screening of cleaning-in-place (CIP) conditions for chromatography resins has been developed. The methodology includes fouling of MabSelect SuRe chromatography resin in 96-well filter plates, cleaning of the fouled resin by incubation in different CIP agents, and finally, analysis of the residual impurities on the resin after cleaning. This article describes the improvements that transformed the method from low throughput and significant manual interference to a totally automated method with high throughput and good reproducibility.
authors.affiliation: GE Healthcare Bio-Sciences AB, Research and Development department, Uppsala, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Grönberg
authors.forename: Malin
authors.initials: M
authors.lastname: Eriksson
authors.forename: Maria
authors.initials: M
authors.lastname: Ersoy
authors.forename: Hans J
authors.initials: HJ
authors.lastname: Johansson
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000302:isolation & purification; D001331:Automation; D016466:CHO Cells; D002846:Chromatography, Affinity / Q000295:instrumentation* / Q000379:methods; D002852:Chromatography, Ion Exchange / Q000295:instrumentation* / Q000379:methods; D006224:Cricetinae; D003412:Cricetulus; D017077:Culture Media, Conditioned; D005374:Filtration / Q000295:instrumentation* / Q000379:methods; D057166:High-Throughput Screening Assays / Q000295:instrumentation / Q000379:methods*; D007475:Ion Exchange Resins / Q000737:chemistry*; D015203:Reproducibility of Results; D012972:Sodium Hydroxide / Q000737:chemistry*
chemical_list: D000911:Antibodies, Monoclonal; D017077:Culture Media, Conditioned; D007475:Ion Exchange Resins; D012972:Sodium Hydroxide