Premium
Cation exchange chromatography performed in overloaded mode is effective in removing viruses during the manufacturing of monoclonal antibodies
Author(s) -
Masuda Yumiko,
Tsuda Masashi,
HashikawaMuto Chie,
Takahashi Yusuke,
aka Koichi,
Wakamatsu Kaori
Publication year - 2019
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1002/btpr.2858
Subject(s) - monoclonal antibody , chinese hamster ovary cell , elution , chemistry , virology , affinity chromatography , virus , chromatography , antibody , biology , biochemistry , immunology , receptor , enzyme
Viral safety is a critical concern with regard to monoclonal antibody (mAb) products produced in mammalian cells such as Chinese hamster ovary cells. Manufacturers are required to ensure the safety of such products by validating the clearance of viruses in downstream purification steps. Cation exchange (CEX) chromatography is widely used in bind/elute mode as a polishing step in mAb purification. However, bind/elute modes require a large volume of expensive resin. To reduce the production cost, the use of CEX chromatography in overloaded mode has recently been investigated. The viral clearance ability in overloaded mode was evaluated using murine leukemia virus (MLV). Even under high‐load conditions such as 2,000 g mAb/L resin, MLV was removed from mAb solutions. This viral clearance ability was not significantly affected by resin type or mAb type. The overloaded mode can also remove other types of viruses such as pseudorabies virus and reovirus Type 3 from mAb solutions. Based on these results, this cost‐effective overloaded mode is comparable to the bind‐elute mode in terms of viral removal.