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Utilizing Dynamic Light Scattering as a Process Analytical Technology for Protein Folding and Aggregation Monitoring in Vaccine Manufacturing.
- Source :
-
Journal of Pharmaceutical Sciences . Dec2013, Vol. 102 Issue 12, p4284-4290. 7p. - Publication Year :
- 2013
-
Abstract
- Protein aggregation is a common challenge in the manufacturing of biological products. It is possible to minimize the extent of aggregation through timely measurement and in-depth characterization of aggregation. In this study, we demonstrated the use of dynamic light scattering ( DLS) to monitor inclusion body ( IB) solubilization, protein refolding, and aggregation near the production line of a recombinant protein-based vaccine candidate. Our results were in good agreement with those measured by size-exclusion chromatography. DLS was also used to characterize the mechanism of aggregation. As DLS is a quick, nonperturbing technology, it can potentially be used as an at-line process analytical technology to ensure complete IB solubilization and aggregate-free refolding. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:4284-4290, 2013 [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00223549
- Volume :
- 102
- Issue :
- 12
- Database :
- Academic Search Index
- Journal :
- Journal of Pharmaceutical Sciences
- Publication Type :
- Academic Journal
- Accession number :
- 92048445
- Full Text :
- https://doi.org/10.1002/jps.23746