Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure.
Buffer flush
Depressurization
High pressure
Planova 20 N
Virus filtration (VF)
Virus leakage
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:
Nov 2023
Nov 2023
Historique:
received:
11
12
2022
revised:
18
09
2023
accepted:
01
10
2023
medline:
4
12
2023
pubmed:
15
10
2023
entrez:
14
10
2023
Statut:
ppublish
Résumé
Virus filtration is a robust and effective method to remove potential virus contaminants. Planova 20 N, a virus filter form Asahi Kasei Bioprocess, has been widely used in the manufacturing process of biotherapeutics. Previous studies have shown that parvovirus removal by Planova 20 N can be impacted by low operation pressure and depressurization. Therefore, it is critical to define an operating pressure range for robust virus removal. In this work, the effect of pressure combined with depressurization on virus removal by Planova 20 N was investigated. Our studies showed that effective virus removal can be achieved in the pressure range from 0.7 bar to 1.6 bar. The data also suggest that re-starting with higher pressure after depressurization is highly desirable for large-scale manufacture to mitigate virus leakage risk. In addition, skipping buffer flush post mainstream filtration minimizes the likelihood of depressurization.
Identifiants
pubmed: 37837714
pii: S1045-1056(23)00056-8
doi: 10.1016/j.biologicals.2023.101718
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
101718Informations de copyright
Copyright © 2023 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.