Targeted CQA analytical control strategy for commercial antibody products: Replacing ion-exchange chromatography methods for charge heterogeneity with multi-attribute monitoring

Peptide mapping with mass spectrometry (MS) is an important tool for protein characterization in the biopharmaceutical industry. Historically, peptide mapping monitors post-translational modifications (PTMs) of protein products and process intermediates during development. Multi-attribute monitoring...

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Principais autores:	Adam R. Evans, Joseph Mulholland, Michael J. Lewis, Ping Hu
Formato:	Artigo
Idioma:	Inglês
Publicado em:	Taylor & Francis Group 2024-12-01
Colecção:	mAbs
Assuntos:	Assay replacement control strategy CQA monitoring MAM mass spectrometry monoclonal antibody
Acesso em linha:	https://www.tandfonline.com/doi/10.1080/19420862.2024.2341641
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