Review on analytical methods for host cell proteins of antibody drugs based on MS
XU Xuan
SHENG Ning
ZHANG Jin-lan
Abstract：Host cell proteins(HCPs)are process-related impurities introduced during the purification of antibody(Ab)drugs,potentially affecting products'quality,stability,and safety.Mass spectrometry(MS)presents advantages to discover,identify,and quantify HCPs with high sensitivity.However,the wide dynamic range between high-abundance therapeutic proteins and low-abundance HCPs in purified antibody samples poses challenges for sample preparation,separation method,and MS analysis,necessitating method optimization to overcome these limitations.This paper reviews the progress in MS-based analysis of HCPs impurities in antibody drugs.
Keywords：host cell proteinMSproteomicsantibody drugimpurity analysis
Publication Date：2025-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 823-828 )