Contaminant control in the purification of monoclonal antibodies: the

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New chromatography technology to improve the antibody purification process
John M. Jenco, Ph.D .
Senior Principal Scientist
Technical Services Group
Pall Life Sciences, USA
Monoclonal antibody production processes begin with the fermentation of mammalian
cells that have been genetically engineered to produce a specific antibody at increasingly
higher titers in various media formulations. Following the harvest of the bioreactor to
separate cells from the media that contains the expressed and secreted antibody, the
subsequent downstream steps must all be aimed at producing therapeutic grade
monoclonal antibody in as high a yield and as high a purity as possible. The challenge for
each purification step is to consistently reduce and/or eliminate common contaminants
such as host cell protein, host cell DNA, virus, and endotoxin that would otherwise cause
adverse reactions if administered to patients. Multiple chromatographic steps are
routinely employed to address the removal of contaminants through several orthogonal
mechanisms. MEP HypercelTM mixed mode chromatography, S HypercelTM cation
exchange chromatography, and Mustang® Q membrane chromatography all contribute to
consistently reducing contaminants while producing robust yields of monoclonal
antibody. These chromatography technologies play a significant role in reducing the high
level of contaminants encountered out of the bioreactor to the low levels required by
regulatory authorities in the final formulated product. The risk of adverse events is
mitigated, and patient safety is not compromised.
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