Review considerations for sequence variants of monoclonal antibody drugs
WU Yong-kai
LI Qian
WEI Wei
Abstract：Monoclonal antibody drugs have become an important component in the field of biological products due to their high specificity and wide clinical application prospects.Product heterogeneity has always been one of the key concerns in industry and regulatory authorities.With the continuous increase in the number of monoclonal antibody products and the accumulation of experience,the industry and regulatory authorities have reached a basic consensus on some heterogeneity issues.However,research and experience on sequence variants are relatively limited and remain an attention focus of regulation and research and development.This article explores the evaluation considerations for sequence variants represented by amino acid substitutions,based on the concept and causes of sequence variants,in combination with evaluation practice,in order to provide references for the development of such drugs.
Keywords：monoclonal antibodysequence variantmonoclonal specificity
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 585-589 )