Modern biologics development relies on the screening of 100s – 1000s of monoclonal antibody (mAb) variants to identify lead development candidates with optimal properties such as affinity, specificity, immunogenicity, and glycosylation.
Antibody aggregation can be an unintended side-effect of these optimizations as it is influenced by molecular attributes as well as those of the expression host. It is controlled and monitored as a critical quality attribute (1). The ability to rapidly assess the propensity of mAb to aggregate is thus a core requirement of modern pharmaceutical development.
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