Need for a risk-based control strategy for managing glycosylation profile for biosimilar products

Monoclonal antibodies, though a popular class of therapeutics, are complex molecules that are manufactured using complex processes, making it nontrivial to maintain high level of batch-to-batch consistency in product quality. Glycosylation is a posttranslation modification that is widely considered a critical quality attribute (CQA) as its variations are known to impact the Fc effector functions of mAbs. With continuing rise of biosimilars,...