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Effect of change in cell substrate on the critical quality attributes of L-Zagreb Mumps vaccine manufactured using parallel plate bioreactor.
- Source :
-
Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 Sep; Vol. 67, pp. 29-37. Date of Electronic Publication: 2020 Aug 24. - Publication Year :
- 2020
-
Abstract
- Leningrad-Zagreb strain of mumps vaccine virus was grown on two different cell substrates viz. MRC-5 cells and Vero cells besides its original cell substrate i.e. Chicken Embryo Cells. Homogeneous virus pools prepared from each set of experiments were then lyophilized as per standard in-house protocol. Critical Quality Attributes (CQAs) such as the titer of the bulk vaccine and potency and stability of the lyophilized vaccine were then estimated using the CCID <subscript>50</subscript> method to understand the lyophilization losses and thermal losses respectively in the vaccine. Another CQA viz. the genetic homogeneity of the vaccine was also tested using the single base extension method for identifying the nucleotides present at the three known locations of single nucleotide polymorphism (SNP). Comparison of CQA results across different cell substrates indicated encouraging results for Vero cell grown L-Zagreb virus compared to the MRC-5 cells grown L-Zagreb mumps virus. Significant improvement in productivity was also observed in the dynamic culture conditions compared to the static culture conditions. Progressive work in this research area can lead to development of a cGMP manufacturing process for mumps vaccine with easy scale up potential in future.<br /> (Copyright © 2020 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.)
- Subjects :
- Animals
Cell Line
Chlorocebus aethiops
Freeze Drying methods
Humans
Mumps prevention & control
Mumps virology
Mumps Vaccine administration & dosage
Mumps Vaccine standards
Mumps virus genetics
Mumps virus physiology
Quality Control
Vaccination
Vaccines, Attenuated administration & dosage
Vaccines, Attenuated immunology
Vaccines, Attenuated standards
Vero Cells
Virus Cultivation instrumentation
Virus Cultivation methods
Bioreactors
Mumps immunology
Mumps Vaccine immunology
Mumps virus immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1095-8320
- Volume :
- 67
- Database :
- MEDLINE
- Journal :
- Biologicals : journal of the International Association of Biological Standardization
- Publication Type :
- Academic Journal
- Accession number :
- 32855039
- Full Text :
- https://doi.org/10.1016/j.biologicals.2020.07.008