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

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Böhl, O.J.; Schellenberg, J.; Bahnemann, J.; Hitzmann, B.; Scheper, T. et al.: Implementation of QbD strategies in the inoculum expansion of a mAb production process. In: Engineering in Life Sciences 21 (2020), Nr. 3-4, S. 196-207. DOI: https://doi.org/10.1002/elsc.202000056

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Sum total of downloads: 73




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Abstract: 
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 process phase, namely the inoculum expansion, was not yet investigated and characterized for most processes. In order to increase the understanding of early process parameter interactions and their influence on the later production process, a risk assessment followed by a design of experiments approach was conducted. The DoE included the critical parameters methotrexate (MTX) concentration, initial passage viable cell density and passage duration. Multivariate data analysis led to mathematical regression models and the establishment of a designated design space for the studied parameters. It was found that the passage duration as well as the initial viable cell density for each passage during the inoculum expansion have severe effects on the growth rate and viability of the early process phase. Furthermore, the variations during the inoculum expansion directly influenced the production process responses. This carry-over of factor effects highlights the crucial impact of early process failures and the importance of process analysis and control during the first part of mAb production processes. © 2020 The Authors. Engineering in Life Sciences published by Wiley-VCH GmbH
License of this version: CC BY 4.0 Unported
Document Type: article
Publishing status: publishedVersion
Issue Date: 2020
Appears in Collections:Naturwissenschaftliche Fakultät

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pos. country downloads
total perc.
1 image of flag of Germany Germany 58 79.45%
2 image of flag of United States United States 7 9.59%
3 image of flag of Tanzania, United Republic of Tanzania, United Republic of 2 2.74%
4 image of flag of Russian Federation Russian Federation 2 2.74%
5 image of flag of Iran, Islamic Republic of Iran, Islamic Republic of 1 1.37%
6 image of flag of Israel Israel 1 1.37%
7 image of flag of Spain Spain 1 1.37%
8 image of flag of China China 1 1.37%

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