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The impact of standard accelerated stability conditions on antibody higher order structure as assessed by mass spectrometry
Protein therapeutic higher order structure (HOS) is a quality attribute that can be assessed to help predict shelf life. To model product shelf-life values, possible sample-dependent pathways of degradation that may affect drug efficacy or safety need to be evaluated. As changes in drug thermal stab...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6601562/ https://www.ncbi.nlm.nih.gov/pubmed/30913973 http://dx.doi.org/10.1080/19420862.2019.1599632 |