Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing

The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS)-based method that is used to directly characterize and monitor numerous product quality attributes (PQAs) at the amino acid level of a biopharmaceutical product. MAM enables identity testing based on primary sequen...

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Veröffentlicht in:	Nature protocols 2023-04, Vol.18 (4), p.1056-1089
Hauptverfasser:	Millán-Martín, Silvia, Jakes, Craig, Carillo, Sara, Rogers, Richard, Ren, Da, Bones, Jonathan
Format:	Artikel
Sprache:	eng
Schlagworte:	631/1647/2067 631/1647/296 631/61/51/1568 631/61/51/2008 639/638/11/296 Amino acid sequence Amino acids Analytical Chemistry Antibodies, Monoclonal - chemistry Biological Techniques Biomedical and Life Sciences Biopharmaceuticals Chromatography Chromatography, Liquid - methods Computational Biology/Bioinformatics Data analysis Digestion High resolution Impurities Libraries Life cycles Life Sciences Liquid chromatography Manufacturing Mass spectrometry Mass Spectrometry - methods Mass spectroscopy Microarrays Monitoring Organic Chemistry Post-translation Product life cycle Product quality Protein Processing, Post-Translational Proteolysis Protocol Quality control Quality management Quantitation Retention time Sample preparation Scientific imaging Separation Workflow
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