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

Abstract 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...

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Principais autores:	Ole Jacob Wohlenberg, Carlotta Kortmann, Katharina V. Meyer, Jana Schellenberg, Katharina Dahlmann, Janina Bahnemann, Thomas Scheper, Dörte Solle
Formato:	Artigo
Idioma:	Inglês
Publicado em:	Maximum Academic Press 2022-07-01
Colecção:	Engineering in Life Sciences
Assuntos:	ambr® chinese hamster ovary monoclonal antibody process analytical technology quality by design
Acesso em linha:	https://doi.org/10.1002/elsc.202100172
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