Development and Validation of a Glycation Analysis Method for Infliximab and Its Universal Application Across Antibody Drugs
XU Mengjiao
LIU Tao
XU Jin
GUO Qingcheng
FU Rongrong
ZHAO Xiang
WANG Fugui
SONG Lankun
JI Lusha
QIAN Weizhu
HOU Sheng
LI Jun
ZHANG Dapeng
GUO Huaizu
Abstract：Glycation,a pivotal non-enzymatic modification process characterized by the covalent attach-ment of reducing sugars to amino acid residues in proteins,is prevalent during the manufacturing and stor-age phases of antibody therapeutics.This process can critically impact drug quality and efficacy.Although boronate affinity chromatography(BAC)is a widely adopted method to assess glycation modifications in antibody drugs,its use in precisely quantifying infliximab glycation levels has encountered significant accu-racy issues,impeding its effectiveness in quality control.Addressing this,our research dissected the ele-ments influencing BAC precision for infliximab,pinpointing specific inaccuracies in glycation detection.Targeted optimization of the mobile phase constituents and concentrations culminated in the establishment of a refined BAC technique.This novel method allows for a more exact quantification of glycation levels in infliximab,with its reliability qualified by a mass spectrometry-based rapid multi-attribute approach,fol-lowed by rigorous methodological validation.Our results underscore the method's exceptional accuracy,precision,and resilience.Extensive testing on a variety of antibody drugs further established the method's versatile suitability for standard glycation assessment.This research not only overcomes seminal techni-cal hurdles in infliximab glycation analysis but also affirms the method's universal applicability.It intro-duces an expedited,precise strategy for antibody drug quality management,promising to expedite en-hancements in technological frameworks and intellectual paradigms,thus fortifying product development and quality oversight capabilities.
Keywords：InfliximabGlycationBoronate affinity chromatographyAntibody therapeuticsQuality controlUniversal application
Publication Date：2024-10-28
Online Publishing Date：2026-08-28(First online date of this platform, not the publication date of the document)
Pages：14( 155-168 )