Expanded bed adsorption in the purification of monoclonal antibodies: a comparison of process alternatives.
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.
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Department of Recovery Sciences, Genentech, Inc., South San Francisco, CA 94080, USA.
Zapata
G
G
Fahrner
R
R
Milton
M
M
Yedinak
C
C
Knudsen
H
H
Schmelzer
C
C
D000327:Adsorption; D000818:Animals; D000911:Antibodies, Monoclonal / Q000302:isolation & purification*; D016466:CHO Cells; D002853:Chromatography, Liquid / Q000379:methods; D006224:Cricetinae
D000911:Antibodies, Monoclonal