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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 ...
Entwicklung einer disposable-Durchflussmesszelle zur spektroskopischen Bioprozessüberwachung

Steinwedel, Tobias (Hannover : Institutionelles Repositorium der Leibniz Universität Hannover, 2022)

Biopharmazeutische Produktionsprozesse dienen der Herstellung komplexer Biomo- leküle zu therapeutischen Zwecken. Wachstumsfaktoren, Impfstoffe oder monoklo- nale Antikörper sind nur einige Beispiele für biotechnologisch ...
Evaluierung der Mittel- und Nahinfrarotspektroskopie zur online Überwachung von CHO-Kultivierungen

Sandor, Marko (Hannover : Gottfried Wilhelm Leibniz Universität Hannover, 2016)

[no abstract]
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 ...
Monitoring online biomass with a capacitance sensor during scale-up of industrially relevant CHO cell culture fed-batch processes in single-use bioreactors

Metze, S.; Ruhl, S.; Greller, G.; Grimm, C.; Scholz, J. (Berlin [u.a.] : Springer, 2020)

In 2004, the FDA published a guideline to implement process analytical technologies (PAT) in biopharmaceutical processes for process monitoring to gain process understanding and for the control of important process parameters. ...

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