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Implementation of a High-Resolution Liquid Chromatography–Mass Spectrometry Method in Quality Control Laboratories for Release and Stability Testing of a Commercial Antibody Product
Izabela Sokolowska
1 ,
Jingjie Mo
1 ,
Fatie Rahimi Pirkolachahi
2 ,
Carol McVean
1 ,
Lars A. T. Meijer
3 ,
Linda Switzar
3 ,
Crina Balog
3 ,
Michael J. Lewis
1 ,
Ping Hu
1
December 27 2019
December 27 2019
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Abstract
<p class="first" id="d3856553e134">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.
</p>