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Implementation of QbD strategies in the inoculum expansion of a mAb production process

The quality by design approach was introduced to the biopharmaceutical industry over 15 years ago. This principle is widely implemented in the characterization of monoclonal antibody production processes. Anyway, the early process phase, namely the inoculum expansion, was not yet investigated and ch...

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Detalles Bibliográficos
Autores principales: Böhl, Ole Jacob, Schellenberg, Jana, Bahnemann, Janina, Hitzmann, Bernd, Scheper, Thomas, Solle, Dörte
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923587/
https://www.ncbi.nlm.nih.gov/pubmed/33716618
http://dx.doi.org/10.1002/elsc.202000056