title: Consistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab).
abstract: Humira® (adalimumab) is a recombinant human IgG1 monoclonal antibody (mAb) glycoprotein consisting of 1330 amino acids that is specific for human tumor necrosis factor (TNF). The biological activity and clinical profile of mAb therapeutics, including adalimumab, is influenced by their protein structure and glycosylation patterns, which can be affected by the expression system, cell culture conditions and purification process methodology. While clinical outcome cannot yet be attributed to many of the individual structural features that constitute a mAb, it is evident that detailed structural attribute analysis is necessary if structural contributions to function are to be comprehensively defined. Adalimumab product quality data generated from over a decade of manufacturing across multiple production sites and through a series of manufacturing scale changes are presented here. These data reveal a consistent and tightly controlled profile for the product.
authors.affiliation: a AbbVie; Global Medical Affairs; Biologics Strategic Development ; North Chicago , IL USA.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Tebbey
authors.forename: Amy
authors.initials: A
authors.lastname: Varga
authors.forename: Michael
authors.initials: M
authors.lastname: Naill
authors.forename: Jerry
authors.initials: J
authors.lastname: Clewell
authors.forename: Jaap
authors.initials: J
authors.lastname: Venema
mesh_terms: D000068879:Adalimumab / Q000737:chemistry*; D000893:Anti-Inflammatory Agents / Q000138:chemical synthesis / Q000737:chemistry*; D000915:Antibody Affinity; D018501:Antirheumatic Agents / Q000138:chemical synthesis / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D055553:Prescription Drugs / Q000592:standards*; D011786:Quality Control
chemical_list: D000893:Anti-Inflammatory Agents; D018501:Antirheumatic Agents; D055553:Prescription Drugs; D000068879:Adalimumab
keywords: adalimumab; biosimilars; manufacturing; oligosaccharides; quality attributes