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Process characterization strategy for a precipitation step for host cell protein reduction
Process characterization using QbD approaches has rarely been described for precipitation steps used for impurity removal in biopharmaceutical processes. We propose a two‐step approach for process characterization in which the first step focuses on product quality and the second focuses on process p...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley & Sons, Inc.
2019
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7027468/ https://www.ncbi.nlm.nih.gov/pubmed/31513727 http://dx.doi.org/10.1002/btpr.2908 |