2022
DOI: 10.1002/bit.28257
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Preferential precipitation of acidic variants from monoclonal antibody pools

Abstract: Microheterogeneity of monoclonal antibodies (mAbs) can impact their activity and stability. Formation of charge variants is considered as the most important source of the microheterogeneity. In particular, controlling the content of the acidic species is often of major importance for the production process and regulatory approval of therapeutic proteins. In this study, the preferential precipitation process was developed for reducing the content of acidic variants in mAb downstream pools. The process design wa… Show more

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Cited by 5 publications
(1 citation statement)
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“…Precipitation is a cost‐effective alternative for the capture of recombinant antibodies from CCCS and continuous operation is achieved in tubular reactors equipped with static mixers [ 23 , 24 ]. Multiple precipitation steps can be performed in a process, targeting product or impurities [ 25 , 26 , 27 ]. When the latter are precipitated, the stream can be easily clarified in continuous by tandem depth filtration and a simple automated system can be implemented for filters exchange, by monitoring the depth filter inlet pressure and outlet turbidity [ 28 ].…”
Section: Introductionmentioning
confidence: 99%
“…Precipitation is a cost‐effective alternative for the capture of recombinant antibodies from CCCS and continuous operation is achieved in tubular reactors equipped with static mixers [ 23 , 24 ]. Multiple precipitation steps can be performed in a process, targeting product or impurities [ 25 , 26 , 27 ]. When the latter are precipitated, the stream can be easily clarified in continuous by tandem depth filtration and a simple automated system can be implemented for filters exchange, by monitoring the depth filter inlet pressure and outlet turbidity [ 28 ].…”
Section: Introductionmentioning
confidence: 99%