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:	Kiran P. Malik, Chinwe Duru, Paul Stickings, Esther Veronika Wenzel, Michael Hust, Paul Matejtschuk
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	lyophilization biologicals formulation stability recombinant antibody Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/f03c573bd3cd495e9e73c21d6a9d97db
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spelling	oai:doaj.org-article:f03c573bd3cd495e9e73c21d6a9d97db2021-11-25T18:42:17ZInvestigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule10.3390/pharmaceutics131119481999-4923https://doaj.org/article/f03c573bd3cd495e9e73c21d6a9d97db2021-11-01T00:00:00Zhttps://www.mdpi.com/1999-4923/13/11/1948https://doaj.org/toc/1999-4923When 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.Kiran P. MalikChinwe DuruPaul StickingsEsther Veronika WenzelMichael HustPaul MatejtschukMDPI AGarticlelyophilizationbiologicalsformulationstabilityrecombinant antibodyPharmacy and materia medicaRS1-441ENPharmaceutics, Vol 13, Iss 1948, p 1948 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	lyophilization biologicals formulation stability recombinant antibody Pharmacy and materia medica RS1-441
spellingShingle	lyophilization biologicals formulation stability recombinant antibody Pharmacy and materia medica RS1-441 Kiran P. Malik Chinwe Duru Paul Stickings Esther Veronika Wenzel Michael Hust Paul Matejtschuk Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule
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.
format	article
author	Kiran P. Malik Chinwe Duru Paul Stickings Esther Veronika Wenzel Michael Hust Paul Matejtschuk
author_facet	Kiran P. Malik Chinwe Duru Paul Stickings Esther Veronika Wenzel Michael Hust Paul Matejtschuk
author_sort	Kiran P. Malik
title	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_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_sort	investigating alternative container formats for lyophilization of biological materials using diphtheria antitoxin monoclonal antibody as a model molecule
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/f03c573bd3cd495e9e73c21d6a9d97db
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Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule

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