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Utilizing Dynamic Light Scattering as a Process Analytical Technology for Protein Folding and Aggregation Monitoring in Vaccine Manufacturing.

Authors :
Yu, Zhou
Reid, Jennifer C.
Yang, Yan-Ping
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