Effect of change in cell substrate on the critical quality attributes of L-Zagreb Mumps vaccine manufactured using parallel plate bioreactor.


Journal

Biologicals : journal of the International Association of Biological Standardization
ISSN: 1095-8320
Titre abrégé: Biologicals
Pays: England
ID NLM: 9004494

Informations de publication

Date de publication:
Sep 2020
Historique:
received: 24 06 2020
revised: 10 07 2020
accepted: 29 07 2020
pubmed: 29 8 2020
medline: 10 8 2021
entrez: 29 8 2020
Statut: ppublish

Résumé

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

Identifiants

pubmed: 32855039
pii: S1045-1056(20)30088-9
doi: 10.1016/j.biologicals.2020.07.008
pii:
doi:

Substances chimiques

Mumps Vaccine 0
Vaccines, Attenuated 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

29-37

Informations de copyright

Copyright © 2020 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Auteurs

Ravindra Muley (R)

Serum Institute of India Pvt. Ltd., Hadapsar, Pune, 411 028, India; Symbiosis International (Deemed University), Lavale, Pune, 412 115, India.

Rajeev Dhere (R)

Serum Institute of India Pvt. Ltd., Hadapsar, Pune, 411 028, India; Symbiosis International (Deemed University), Lavale, Pune, 412 115, India. Electronic address: rajeev.dhere@seruminstitute.com.

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Classifications MeSH