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

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dc.identifier.uri Böhl, Ole Jacob Schellenberg, Jana Bahnemann, Janina Hitzmann, Bernd Scheper, Thomas Solle, Dörte 2021-03-30T06:51:17Z 2021-03-30T06:51:17Z 2020
dc.identifier.citation 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:
dc.description.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 eng
dc.language.iso eng
dc.publisher Weinheim : Wiley-VCH Verl.
dc.relation.ispartofseries Engineering in Life Sciences 21 (2020), Nr. 3-4
dc.rights CC BY 4.0 Unported
dc.subject CHO eng
dc.subject inoculum expansion eng
dc.subject mAb eng
dc.subject PAT eng
dc.subject QbD eng
dc.subject.ddc 660 | Technische Chemie ger
dc.title Implementation of QbD strategies in the inoculum expansion of a mAb production process
dc.type article
dc.type Text
dc.relation.essn 1618-2863
dc.relation.issn 1618-0240
dc.bibliographicCitation.issue 3-4
dc.bibliographicCitation.volume 21
dc.bibliographicCitation.firstPage 196
dc.bibliographicCitation.lastPage 207
dc.description.version publishedVersion
tib.accessRights frei zug�nglich

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