Metal ion interactions with mAbs: Part 1: pH and conformation modulate copper-mediated site-specific fragmentation of the IgG1 hinge region
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ZK Glover, L Basa, B Moore, JS Laurence, A Sreedhara
MAbs, 2015
Taylor & Francis
Fragmentation in the hinge region of an IgG1 monoclonal antibody (mAb) can affect product stability, potentially causing changes in potency and efficacy. Metals ions, such as Cu2+, can bind to the mAb and undergo hydrolysis or oxidation, which can lead to cleavage of the molecule. To better understand the mechanism of Cu2+-mediated mAb fragmentation, hinge region cleavage products and their rates of formation were studied as a function of pH with and without Cu2+. More detailed analysis of the chemical changes was investigated using …

