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Method Development and Qualification of pH-Based CEX UPLC Method for Monoclonal Antibodies

Post-translational modifications (“PTMs”) in monoclonal antibodies (mAbs) contribute to charge variant distribution, which will affect biological efficacy and safety. For the characterization of mAbs, charge variants are used as a critical quality attributes for product quality, stability consistenc...

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Detalles Bibliográficos
Autores principales: Bhatt, Mithun, Alok, Anshu, Kulkarni, Bhushan B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9264391/
https://www.ncbi.nlm.nih.gov/pubmed/35822792
http://dx.doi.org/10.3390/biotech11020019