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...
Main Authors: | , , , , |
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Format: | Article |
Language: | English |
Published: |
Wiley-VCH
2023-02-01
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Series: | Engineering in Life Sciences |
Subjects: | |
Online Access: | https://doi.org/10.1002/elsc.202200056 |