On the achievable consistency of glycan distribution in biomanufacturing of therapeutic mAbs.

Abstract

Recombinant monoclonal antibody (mAb) therapeutics exhibit lot-to-lot glycosylation variation influenced by manufacturing processes, which remains underexplored publicly. This study analyzed five years of trastuzumab and adalimumab lots, revealing up to 4% range of variation in glycan relative abundance and significant change or drift of ~1% by ANOVA, levels unlikely to affect mAb efficacy or safety. The results suggest that modern manufacturing can maintain consistent glycan profiles within realistically achievable ranges.