Virus disinfection for biotechnology applications: Different effectiveness on surface versus in suspension.

Biotherapeutics Glutaraldehyde Hydrogen peroxide/ peroxyacetic acid Plasma products Sodium hypochlorite Virus disinfection

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:
Mar 2020
Historique:
received: 12 11 2019
revised: 29 01 2020
accepted: 04 02 2020
pubmed: 15 2 2020
medline: 15 12 2020
entrez: 15 2 2020
Statut: ppublish

Résumé

Virus contamination events in cell culture-based biotechnology processes have occurred and have had a dramatic impact on the supply of life-saving drugs, and thus on the wellbeing of patients. Cleanup requires effective and robust virucidal decontamination procedures for both the liquid reactor content before discharge, as well as facility surfaces to prevent recurrence. Beyond rare contamination events, it is important to implement virucidal disinfection for change-over procedures as effective preventive measure in routine biomanufacturing. Knowledge of the virus inactivation capacity of commonly used disinfectants is therefore important. However, available virus inactivation data often refer to studies performed in suspension only, and not, as often more relevant, to virus inactivation on surfaces. In this study three liquid disinfectants, based on sodium hypochlorite, glutaraldehyde, or hydrogen peroxide/peroxyacetic acid, as well as one gaseous hydrogen peroxide-based disinfectant were investigated for inactivation of lipid enveloped and non-lipid enveloped model viruses, using suspension (for the liquid disinfectants) and carrier assay designs for their virucidal efficacy on surface. The results of these side-by-side investigations demonstrate that depending on the type of application, i.e. routine surface disinfection or decontamination of e.g. a contaminated bioreactor content, the most effective choice of disinfectant may be remarkably different.

Identifiants

pubmed: 32057565
pii: S1045-1056(20)30023-3
doi: 10.1016/j.biologicals.2020.02.002
pii:
doi:

Substances chimiques

Disinfectants 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1-9

Informations de copyright

Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest All authors are employees of Baxter AG, Vienna, Austria, now part of of the Takeda group of companies. J.M., M.K. and T.R.K. are Takeda stock owners.

Auteurs

Johanna Kindermann (J)

Global Pathogen Safety, Baxter AG, Benatzkygasse 2-6, 1221, Vienna, Austria(1). Electronic address: johanna.kindermann@takeda.com.

Michael Karbiener (M)

Global Pathogen Safety, Baxter AG, Benatzkygasse 2-6, 1221, Vienna, Austria(1). Electronic address: michael.karbiener@takeda.com.

Sandra M Leydold (SM)

Global Pathogen Safety, Baxter AG, Benatzkygasse 2-6, 1221, Vienna, Austria(1). Electronic address: sandra.leydold@takeda.com.

Simone Knotzer (S)

Global Pathogen Safety, Baxter AG, Benatzkygasse 2-6, 1221, Vienna, Austria(1). Electronic address: simone.knotzer@takeda.com.

Jens Modrof (J)

Global Pathogen Safety, Baxter AG, Benatzkygasse 2-6, 1221, Vienna, Austria(1). Electronic address: jens.modrof@takeda.com.

Thomas R Kreil (TR)

Global Pathogen Safety, Baxter AG, Benatzkygasse 2-6, 1221, Vienna, Austria(1). Electronic address: thomas.kreil@takeda.com.

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Classifications MeSH