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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...
Autores principales: | Bosley, Allen, Cook, Kimberly, Lin, Shihua, Robbins, David |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2022
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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 |
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