Biopharmaceutical quality control with mass spectrometry

Author:

Liu Shulei12ORCID,Schulz Benjamin L12ORCID

Affiliation:

1. School of Chemistry & Molecular Biosciences, The University of Queensland, St Lucia, QLD 4072, Australia

2. Australian Research Council Industrial Transformation Training Centre for Biopharmaceutical Innovation, Australian Institute for Bioengineering & Nanotechnology, The University of Queensland, St Lucia, QLD 4072, Australia

Abstract

Mass spectrometry (MS) is a powerful technique for protein identification, quantification and characterization that is widely applied in biochemical studies, and which can provide data on the quantity, structural integrity and post-translational modifications of proteins. It is therefore a versatile and widely used analytic tool for quality control of biopharmaceuticals, especially in quantifying host-cell protein impurities, identifying post-translation modifications and structural characterization of biopharmaceutical proteins. Here, we summarize recent advances in MS-based analyses of these key quality attributes of the biopharmaceutical development and manufacturing processes.

Funder

Australian Research Council

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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