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Optimization of a mAb production process with regard to robustness and product quality using quality by design principles

Quality by Design principles are well described and widely used in biopharmaceutical industry. The characterization of a monoclonal antibody (mAb) production process is crucial for novel process development and control. Yet, the application throughout the entire upstream process was rarely demonstra...

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Detalles Bibliográficos
Autores principales: Wohlenberg, Ole Jacob, Kortmann, Carlotta, Meyer, Katharina V., Schellenberg, Jana, Dahlmann, Katharina, Bahnemann, Janina, Scheper, Thomas, Solle, Dörte
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9288990/
https://www.ncbi.nlm.nih.gov/pubmed/35865649
http://dx.doi.org/10.1002/elsc.202100172