Development and qualification of 3 L scale-down model for large scale vaccine process on vero cell culture using microcarriers.
Biotechnol Bioeng
; 2024 Jul 11.
Article
in En
| MEDLINE
| ID: mdl-38993032
ABSTRACT
Scale-down models (SDM) are pivotal tools for process understanding and improvement to accelerate the development of vaccines from laboratory research to global commercialization. In this study, a 3 L SDM representing a 50 L scale Vero cell culture process of a live-attenuated virus vaccine using microcarriers was developed and qualified based on the constant impeller power per volume principle. Both multivariate data analysis (MVDA) and the traditional univariate data analysis showed comparable and equivalent cell growth, metabolic activity, and product quality results across scales. Computational fluid dynamics simulation further confirmed similar hydrodynamic stress between the two scales.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Language:
En
Journal:
Biotechnol Bioeng
Year:
2024
Type:
Article
Affiliation country:
United States