Implementation of a High-Resolution Liquid Chromatography-Mass Spectrometry Method in Quality Control Laboratories for Release and Stability Testing of a Commercial Antibody Product

Anal Chem. 2020 Feb 4;92(3):2369-2373. doi: 10.1021/acs.analchem.9b05036. Epub 2019 Dec 27.

Abstract

Liquid chromatography-mass spectrometry (LC-MS) has been widely used throughout biotherapeutic development. However, its implementation in GMP-compliant commercial quality control (QC) laboratories remains a challenge. In this publication, we describe the covalidation and implementation of an automated, high-throughput, and GMP compliant subunit LC-MS method for monitoring antibody oxidation for commercial product release and stability testing. To our knowledge, this is the first report describing the implementation of a high-resolution LC-MS method in commercial QC laboratories for product release and stability testing in the biopharmaceutical industry. This work paves the road for implementing additional LC-MS methods to modernize testing in commercial QC with more targeted control of product quality.

MeSH terms

  • Antibodies / analysis*
  • Chromatography, Liquid
  • Laboratories
  • Mass Spectrometry
  • Quality Control

Substances

  • Antibodies