Employing QbD strategies to assess the impact of cell viability and density on the primary recovery of monoclonal antibodies

Abstract Quality by Design (QbD) is one of the most important tools for the implementation of Process Analytical Technology (PAT) in biopharmaceutical production. For optimal characterization of a monoclonal antibody (mAb) upstream process a stepwise approach was implemented. The upstream was divide...

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Bibliographic Details
Main Authors: Ole Jacob Wohlenberg, Carlotta Kortmann, Katharina V. Meyer, Thomas Scheper, Dörte Solle
Format: Article
Language:English
Published: Wiley-VCH 2023-02-01
Series:Engineering in Life Sciences
Subjects:
Online Access:https://doi.org/10.1002/elsc.202200056