title: Ultrafast Separation and Analysis of Monoclonal Antibody Aggregates Using Membrane Chromatography.
abstract: We discuss a method for rapid and cost-effective analysis of monoclonal antibody (mAb) aggregates. Hydrophobic interaction membrane chromatography, which was previously shown to be highly suitable for such separation and analysis, was used in a recently developed format referred to as laterally fed membrane chromatography (or LFMC). A stack of rectangular polyvinylidene fluoride (or PVDF) membranes having 0.22 μm pores housed within a modified analytical-scale LFMC device was used for analyzing aggregate types and content in different monoclonal antibody samples. High-resolution separations could be achieved in less than 1.5 min, this being faster than other currently available techniques such as size exclusion ultraperformance liquid chromatography (SE-UPLC). Moreover, the operating pressure was less than 200 kPa, which eliminated the need for an expensive high-pressure pump and chromatography system. The resolution obtained using the LFMC was comparable to that obtained using SE-UPLC. The effect of design variations such as change in dead volume and pillar size within the lateral channels within the LFMC device was also examined.
authors.affiliation: Department of Chemical Engineering, McMaster University , 1280 Main Street West, Hamilton, Ontario L8S 4L7, Canada.
authors.forename: Pedram
authors.initials: P
authors.lastname: Madadkar
authors.affiliation: Department of Chemical Engineering, McMaster University , 1280 Main Street West, Hamilton, Ontario L8S 4L7, Canada.
authors.forename: Umatheny
authors.initials: U
authors.lastname: Umatheva
authors.affiliation: Freelance Scientist, Oxford OX3 0SJ, United Kingdom.
authors.forename: Geoff
authors.initials: G
authors.lastname: Hale
authors.affiliation: National Research Council of Canada , Montreal, Quebec H4P 2R2, Canada.
authors.forename: Yves
authors.initials: Y
authors.lastname: Durocher
authors.affiliation: Department of Chemical Engineering, McMaster University , 1280 Main Street West, Hamilton, Ontario L8S 4L7, Canada.
authors.forename: Raja
authors.identifier: 0000-0001-5965-0081
authors.initials: R
authors.lastname: Ghosh
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000737:chemistry* / Q000235:genetics / Q000378:metabolism; D016466:CHO Cells; D002850:Chromatography, Gel; D002851:Chromatography, High Pressure Liquid; D006224:Cricetinae; D003412:Cricetulus; D019281:Dimerization; D057927:Hydrophobic and Hydrophilic Interactions; D011145:Polyvinyls / Q000737:chemistry; D066329:Protein Aggregates; D005465:Fluorocarbon Polymers
chemical_list: D000911:Antibodies, Monoclonal; D011145:Polyvinyls; D066329:Protein Aggregates; C024865:polyvinylidene fluoride; D005465:Fluorocarbon Polymers