Workflow for Criticality Assessment Applied in Biopharmaceutical Process Validation Stage 1

Identification of critical process parameters that impact product quality is a central task during regulatory requested process validation. Commonly, this is done via design of experiments and identification of parameters significantly impacting product quality (rejection of the null hypothesis that...

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Detalles Bibliográficos
Autores principales: Zahel, Thomas, Marschall, Lukas, Abad, Sandra, Vasilieva, Elena, Maurer, Daniel, Mueller, Eric M., Murphy, Patrick, Natschläger, Thomas, Brocard, Cécile, Reinisch, Daniela, Sagmeister, Patrick, Herwig, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2017
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5746752/
https://www.ncbi.nlm.nih.gov/pubmed/29023375
http://dx.doi.org/10.3390/bioengineering4040085

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