title: Expanded bed adsorption in the purification of monoclonal antibodies: a comparison of process alternatives.
abstract: Expanded bed adsorption (EBA) was examined as the initial capture/purification step in the purification of monoclonal antibodies from Chinese hamster ovary (CHO) cultures. Two process alternatives each using EBA were compared to a conventional Protein A process without EBA. One alternative used Protein A affinity EBA followed by packed-bed cation and anion-exchange steps. The other alternative used cation-exchange EBA as the capture step followed by packed-bed Protein A and anion-exchange steps. The process using Protein A EBA produced comparable purity (host cell protein, DNA, Protein A, antibody aggregate) to the conventional process. However, the Protein A EBA column showed a significant decrease in dynamic capacity with a limited number of cycles. The process using cation EBA achieved comparable levels of host cell proteins (HCP) and DNA but not antibody aggregate or leached Protein A compared to the conventional process.
authors.affiliation: Department of Recovery Sciences, Genentech, Inc., South San Francisco, CA 94080, USA.
authors.forename: G S
authors.initials: GS
authors.lastname: Blank
authors.forename: G
authors.initials: G
authors.lastname: Zapata
authors.forename: R
authors.initials: R
authors.lastname: Fahrner
authors.forename: M
authors.initials: M
authors.lastname: Milton
authors.forename: C
authors.initials: C
authors.lastname: Yedinak
authors.forename: H
authors.initials: H
authors.lastname: Knudsen
authors.forename: C
authors.initials: C
authors.lastname: Schmelzer
mesh_terms: D000327:Adsorption; D000818:Animals; D000911:Antibodies, Monoclonal / Q000302:isolation & purification*; D016466:CHO Cells; D002853:Chromatography, Liquid / Q000379:methods; D006224:Cricetinae
chemical_list: D000911:Antibodies, Monoclonal