Development and Validation of a Quadrupole Dalton-Based Multi-Attribute Method for the Quality Control of an Antibody Drug with Multiple Glycosylation Sites
WANG Fugui
LIU Tao
LI Jinhao
XU Mengjiao
FU Rongrong
ZHAO Xiang
NIE Aiying
SONG Lankun
CHEN Xi
JI Lusha
QIAN Weizhu
HOU Sheng
LI Jun
XU Zhongsheng
FAN Wenqiang
ZHANG Dapeng
XU Jin
GUO Qingcheng
Abstract：Antibody drugs are pivotal in biopharmaceuticals,featuring complex quality attributes that complicate quality control,especially those with multiple glycosylation sites.Although high-resolution mass spectrometry-based multi-attribute methods(MAM)are established for quality control,rapid and straightforward testing methods for such antibodies are limited.This study introduces a Quadrupole Dal-ton-based MAM,enhancing quality control efficiency significantly.We used the therapeutic monoclonal antibody CMAB009,with dual glycosylation sites,as a model.Extensive pre-characterization with high-resolution MAM captured its primary quality attributes effectively.This data informed the development of a Quadrupole Dalton-based MAM that successfully monitored multiple quality attributes in a single analy-sis.Its accuracy,verified against high-resolution mass spectrometry,and thorough methodological valida-tion,confirmed its high specificity,linearity,accuracy,and precision.This Quadrupole Dalton-based MAM not only addresses the challenges in multi-attribute testing of monoclonal antibodies with multiple glycosylation sites but also offers a new,simplified approach to quality control for various antibody drugs.This research is poised to enhance technology platforms and inspire conceptual innovations,thus boosting overall product development and quality control capabilities.
Keywords：antibody drugmulti-attribute methodquality controlCMAB009quadrupole dalton
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( 169-182 )