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Generation of Recombinant Human IgG Monoclonal Antibodies from Immortalized Sorted B Cells
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Modifications of recombinant monoclonal antibodies in vivo

Hongcheng Liu1, Christine Nowak1, Rekha Patel1

  • 1Product Characterization, Alexion Pharm., 100 College Street, New Haven, CT, USA.

Biologicals : Journal of the International Association of Biological Standardization
|March 27, 2019
PubMed

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.

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