Browsing by Subject "QbD"

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

Wohlenberg, Ole Jacob; Kortmann, Carlotta; Meyer, Katharina V.; Scheper, Thomas; Solle, Dörte (Weinheim : Wiley-VCH, 2023)

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

Böhl, Ole Jacob; Schellenberg, Jana; Bahnemann, Janina; Hitzmann, Bernd; Scheper, Thomas; Solle, Dörte (Weinheim : Wiley-VCH Verl., 2020)

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 ...

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