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Identification, characterization and control of a sequence variant in monoclonal antibody drug product: a case study
Sequence variants (SV) in protein bio therapeutics can be categorized as unwanted impurities and may raise serious concerns in efficacy and safety of the product. Early detection of specific sequence modifications, that can result in altered physicochemical and or biological properties, is therefore...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8225904/ https://www.ncbi.nlm.nih.gov/pubmed/34168178 http://dx.doi.org/10.1038/s41598-021-92338-1 |