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Improved process intermediate stability through the identification and elimination of reactive glycation residues – a monoclonal antibody case study

The manufacturing of therapeutic biologics can result in a heterogeneous population of charge variants, encompassing many quality attributes which could impact activity and pharmacokinetics. Monitoring the relative abundance of these charge variants to demonstrate process consistency is an expectati...

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Detalles Bibliográficos
Autores principales: Bosley, Allen, Cook, Kimberly, Lin, Shihua, Robbins, David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9342189/
https://www.ncbi.nlm.nih.gov/pubmed/35757891
http://dx.doi.org/10.1080/21655979.2022.2086350