Leveraging flow mechanics to determine critical process and scaling parameters in a continuous viral inactivation reactor.
Dean vortices
continuous manufacturing
scale down
scale up
viral inactivation
Journal
Biotechnology and bioengineering
ISSN: 1097-0290
Titre abrégé: Biotechnol Bioeng
Pays: United States
ID NLM: 7502021
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
24
06
2019
revised:
18
10
2019
accepted:
03
11
2019
pubmed:
12
11
2019
medline:
23
2
2021
entrez:
12
11
2019
Statut:
ppublish
Résumé
A continuous viral inactivation (CVI) chamber has been designed to operate with acceptable residence time distribution (RTD) characteristics. However, altering the CVI's geometry and operation to accommodate the scale was not obvious. In this work, we elucidate the influence of Dean vortices and leverage the transition into the weak turbulent regime to establish relationships between input variables and process outputs. This study was targeted to understand and quantify the impact of viscosity, Dean number, internal diameter, and path length on the RTD. When the Dean number exceeds 70, radial mixing generated by the Dean vortices began to consistently alter the axial dispersive effects experienced by the pulse injection. Increasing to a Dean number of >100, the axial dispersive effects were dominated by the Dean vortices which allowed the calculation of the minimum and maximum residence time to be generated. This work provides a method to calculate operational solutions for a tubular incubation reactor in terms of path length, internal diameter, flow rate, and target minimum and maximum residence time specifications that assures both viral residence times while also establishing criteria to maximize product quality during continuous operation.
Substances chimiques
Antibodies, Monoclonal
0
Biological Products
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
637-645Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
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