Evaluation of a sterile filtration process for viral vaccines using a model nanoparticle suspension.
fouling
live-attenuated virus
sterile filtration
vaccine
virus-like particle
Journal
Biotechnology and bioengineering
ISSN: 1097-0290
Titre abrégé: Biotechnol Bioeng
Pays: United States
ID NLM: 7502021
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
13
06
2020
revised:
28
08
2020
accepted:
31
08
2020
pubmed:
4
9
2020
medline:
26
11
2021
entrez:
4
9
2020
Statut:
ppublish
Résumé
There is growing interest in the development of new vaccines based on live-attenuated viruses (LAVs) and virus-like particles. The large size of these vaccines, typically 100-400 nm, significantly complicates the use of sterile filtration. The objectives of this study are to examine the performance of several commercial sterile filters for filtration of a cytomegalovirus vaccine candidate (referred to as the LAV) and to develop and evaluate the use of a model nanoparticle suspension to perform a more quantitative assessment. Data obtained with a mixture of 200- and 300-nm fluorescent particles provided yield and pressure profiles that captured the behavior of the viral vaccine. This included the excellent performance of the Sartorius Sartobran P filter, which provided greater than 80% yield of both the vaccine and model particles even though the average particle size was more than 250 nm. The particle yield for the Sartobran P was independent of filtrate flux above 200 L/m
Substances chimiques
Vaccines, Attenuated
0
Viral Vaccines
0
Types de publication
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106-115Subventions
Organisme : Merck Sharp and Dohme
ID : PSU-2019
Informations de copyright
© 2020 Wiley Periodicals LLC.
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