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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...
Autores principales: | Böhl, Ole Jacob, Schellenberg, Jana, Bahnemann, Janina, Hitzmann, Bernd, Scheper, Thomas, Solle, Dörte |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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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 |
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