Consistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab).
作者： Paul W Tebbey , Amy Varga , Michael Naill , Jerry Clewell , Jaap Venema
DOI: 10.1080/19420862.2015.1073429
关键词:
摘要: Humira® (adalimumab) is a recombinant human IgG1 monoclonal antibody (mAb) glycoprotein consisting of 1330 amino acids that specific for tumor necrosis factor (TNF). The biological activity and clinical profile mAb therapeutics, including adalimumab, influenced by their protein structure glycosylation patterns, which can be affected the expression system, cell culture conditions purification process methodology. While outcome cannot yet attributed to many individual structural features constitute mAb, it evident detailed attribute analysis necessary if contributions function are comprehensively defined. Adalimumab product quality data generated from over decade manufacturing across multiple production sites through series scale changes presented here. These reveal consistent tightly controlled product.
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