Abstract
Therapeutic recombinant monoclonal antibodies are subject to various modifications during cell culture, and to a lesser degree, during purification. These modifications are expected to remain relatively constant during storage with the protection of appropriate formulations. However, after administration to patients, the levels of modifications may vary over time in circulation, where the recombinant monoclonal antibodies are exposed to the physiological conditions. Scientific understanding of those in vivo modifications can help drug candidate selection to choose the most stable molecules and set appropriate specifications for product release, which ultimately ensures safety and efficacy.
Copyright © 2019. Published by Elsevier Ltd.
MeSH terms
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Animals
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Antibodies, Monoclonal / blood
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Antibodies, Monoclonal / chemistry*
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Antibodies, Monoclonal / metabolism
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Asparagine / chemistry
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Asparagine / metabolism
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Cysteine / chemistry
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Cysteine / metabolism
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Disulfides / chemistry
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Disulfides / metabolism
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Glutamine / chemistry
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Glutamine / metabolism
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Glycosylation
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Humans
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Lysine / chemistry
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Lysine / metabolism
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Pharmaceutical Preparations / chemistry*
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Pharmaceutical Preparations / metabolism
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Protein Processing, Post-Translational*
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Recombinant Proteins / blood
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Recombinant Proteins / chemistry*
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Recombinant Proteins / metabolism
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Succinimides / chemistry
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Succinimides / metabolism
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Time Factors
Substances
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Antibodies, Monoclonal
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Disulfides
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Pharmaceutical Preparations
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Recombinant Proteins
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Succinimides
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Glutamine
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succinimide
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Asparagine
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Lysine
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Cysteine