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Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule

When preparing biological reference materials, the stability of the lyophilized product is critical for long-term storage, particularly in order to meet WHO International Standards, which are not assigned expiry dates but are expected to be in use for several decades. Glass ampoules are typically us...

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Autores principales: Malik, Kiran P., Duru, Chinwe, Stickings, Paul, Wenzel, Esther Veronika, Hust, Michael, Matejtschuk, Paul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8620784/
https://www.ncbi.nlm.nih.gov/pubmed/34834363
http://dx.doi.org/10.3390/pharmaceutics13111948
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author Malik, Kiran P.
Duru, Chinwe
Stickings, Paul
Wenzel, Esther Veronika
Hust, Michael
Matejtschuk, Paul
author_facet Malik, Kiran P.
Duru, Chinwe
Stickings, Paul
Wenzel, Esther Veronika
Hust, Michael
Matejtschuk, Paul
author_sort Malik, Kiran P.
collection PubMed
description When preparing biological reference materials, the stability of the lyophilized product is critical for long-term storage, particularly in order to meet WHO International Standards, which are not assigned expiry dates but are expected to be in use for several decades. Glass ampoules are typically used by the National Institute for Biological Standards and Control (NIBSC) for the lyophilization of biological materials. More recently, a clear need has arisen for the filling of smaller volumes, for which ampoules may not be optimal. We investigated the use of plastic microtubes as an alternative container for small volume fills. In this study, a recombinant diphtheria antitoxin monoclonal antibody (DATMAB) was used as a model molecule to investigate the suitability of plastic microtubes for filling small volumes. The stability and quality of the dried material was assessed after an accelerated degradation study using a toxin neutralization test and size exclusion HPLC. While microtubes have shown some promise in the past for use in the lyophilization of some biological materials, issues with stability may arise when more labile materials are freeze-dried. We demonstrate here that the microtube format is unsuitable for ensuring the stability of this monoclonal antibody.
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spelling pubmed-86207842021-11-27 Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule Malik, Kiran P. Duru, Chinwe Stickings, Paul Wenzel, Esther Veronika Hust, Michael Matejtschuk, Paul Pharmaceutics Communication When preparing biological reference materials, the stability of the lyophilized product is critical for long-term storage, particularly in order to meet WHO International Standards, which are not assigned expiry dates but are expected to be in use for several decades. Glass ampoules are typically used by the National Institute for Biological Standards and Control (NIBSC) for the lyophilization of biological materials. More recently, a clear need has arisen for the filling of smaller volumes, for which ampoules may not be optimal. We investigated the use of plastic microtubes as an alternative container for small volume fills. In this study, a recombinant diphtheria antitoxin monoclonal antibody (DATMAB) was used as a model molecule to investigate the suitability of plastic microtubes for filling small volumes. The stability and quality of the dried material was assessed after an accelerated degradation study using a toxin neutralization test and size exclusion HPLC. While microtubes have shown some promise in the past for use in the lyophilization of some biological materials, issues with stability may arise when more labile materials are freeze-dried. We demonstrate here that the microtube format is unsuitable for ensuring the stability of this monoclonal antibody. MDPI 2021-11-17 /pmc/articles/PMC8620784/ /pubmed/34834363 http://dx.doi.org/10.3390/pharmaceutics13111948 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Communication
Malik, Kiran P.
Duru, Chinwe
Stickings, Paul
Wenzel, Esther Veronika
Hust, Michael
Matejtschuk, Paul
Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule
title Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule
title_full Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule
title_fullStr Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule
title_full_unstemmed Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule
title_short Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule
title_sort investigating alternative container formats for lyophilization of biological materials using diphtheria antitoxin monoclonal antibody as a model molecule
topic Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8620784/
https://www.ncbi.nlm.nih.gov/pubmed/34834363
http://dx.doi.org/10.3390/pharmaceutics13111948
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