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

Izabela Sokolowska | Zendy; Jingjie Mo | Zendy; Fatie Rahimi Pirkolachahi | Zendy; Carol McVean | Zendy; Lars A.T. Meijer | Zendy; Linda Switzar | Zendy; Crina I.A. Balog | Zendy; Michael Lewis | Zendy; Ping Hu | Zendy

Open Access

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

Author(s) -

Izabela Sokolowska,

Jingjie Mo,

Fatie Rahimi Pirkolachahi,

Carol McVean,

Lars A.T. Meijer,

Linda Switzar,

Crina I.A. Balog,

Michael Lewis,

Ping Hu

Publication year - 2019

Publication title -

analytical chemistry

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.117

H-Index - 332

eISSN - 1520-6882

pISSN - 0003-2700

DOI - 10.1021/acs.analchem.9b05036

Subject(s) - chemistry , biopharmaceutical , chromatography , mass spectrometry , liquid chromatography–mass spectrometry , quality (philosophy) , product (mathematics) , resolution (logic) , process engineering , computer science , engineering , microbiology and biotechnology , artificial intelligence , philosophy , geometry , mathematics , epistemology , biology

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.

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