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Disulfide Bond Scrambling / Isoforms / Aggregate Formation

Deamidation
Figure1: Disulfide bond scrambling / isoforms / aggregate formation

Incorrect disulfide bond formation and disulfide bond exchange are common side-effects of extended mAb storage that can lead to cross-linking and antibody aggregation. Aggregation not only results in reduced efficacy of the biopharmaceutical, but also increases the risk of inducing an immune response to the mAb rather than the pathogenic antigen it was supposed to detect. The level of aggregation in biopharmaceutical mAb products must therefore be less than 5%.

Isomers of IgG2
Figure 2: Isomers of IgG2 which show different efficacy

Other post-translational modifications include the formation of additional disulfide bridges in the complementarity determining region (CDR) of the mAb as well as the formation of thioethers and trisulfide bond formation in the hinge region.

 
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