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Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes

In the vaccine industry, multiple physicochemical, immunological, in vitro and in vivo analytical methods are applied throughout the manufacturing process to characterize and monitor the quality of vaccines. Presented here is the Single Epitope Antigenicity Test (SEAT), an innovative, quantitative e...

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Autores principales: Houy, Camille, Ming, Marin, Ettorre, Luciano, Jin, Robbie, Thangavadivel, Nemika, Chen, Tricia, Su, Jin, Gajewska, Beata
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9147534/
https://www.ncbi.nlm.nih.gov/pubmed/35632531
http://dx.doi.org/10.3390/vaccines10050775
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author Houy, Camille
Ming, Marin
Ettorre, Luciano
Jin, Robbie
Thangavadivel, Nemika
Chen, Tricia
Su, Jin
Gajewska, Beata
author_facet Houy, Camille
Ming, Marin
Ettorre, Luciano
Jin, Robbie
Thangavadivel, Nemika
Chen, Tricia
Su, Jin
Gajewska, Beata
author_sort Houy, Camille
collection PubMed
description In the vaccine industry, multiple physicochemical, immunological, in vitro and in vivo analytical methods are applied throughout the manufacturing process to characterize and monitor the quality of vaccines. Presented here is the Single Epitope Antigenicity Test (SEAT), an innovative, quantitative epitope profiling method which provides an extended immunochemical analysis for diphtheria toxoid (DTxd) to be used for consistency testing during manufacturing process changes. The method uses BioLayer Interferometry (BLI) and a panel of monoclonal antibodies (mAbs) to independently assess nine individual antigenic sites of DTxd. The panel includes mAbs which are functional, bind distinct sites on DTxd and are able to distinguish intact DTxd from that which has been exposed to heat treatment. The SEAT method was qualified for precision, accuracy, and linearity, and was used to define a preliminary comparability range for DTxd made using the current manufacturing process. DTxd lots manufactured using alternate processes were assessed in the context of this range to determine the impact on DTxd antigenicity. Epitope profiling by SEAT provides quantitative information on the integrity of multiple important antigenic regions of DTxd, and therefore represents a valuable tool in a comprehensive analytical test package which can be used to support manufacturing process changes for vaccines.
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spelling pubmed-91475342022-05-29 Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes Houy, Camille Ming, Marin Ettorre, Luciano Jin, Robbie Thangavadivel, Nemika Chen, Tricia Su, Jin Gajewska, Beata Vaccines (Basel) Article In the vaccine industry, multiple physicochemical, immunological, in vitro and in vivo analytical methods are applied throughout the manufacturing process to characterize and monitor the quality of vaccines. Presented here is the Single Epitope Antigenicity Test (SEAT), an innovative, quantitative epitope profiling method which provides an extended immunochemical analysis for diphtheria toxoid (DTxd) to be used for consistency testing during manufacturing process changes. The method uses BioLayer Interferometry (BLI) and a panel of monoclonal antibodies (mAbs) to independently assess nine individual antigenic sites of DTxd. The panel includes mAbs which are functional, bind distinct sites on DTxd and are able to distinguish intact DTxd from that which has been exposed to heat treatment. The SEAT method was qualified for precision, accuracy, and linearity, and was used to define a preliminary comparability range for DTxd made using the current manufacturing process. DTxd lots manufactured using alternate processes were assessed in the context of this range to determine the impact on DTxd antigenicity. Epitope profiling by SEAT provides quantitative information on the integrity of multiple important antigenic regions of DTxd, and therefore represents a valuable tool in a comprehensive analytical test package which can be used to support manufacturing process changes for vaccines. MDPI 2022-05-13 /pmc/articles/PMC9147534/ /pubmed/35632531 http://dx.doi.org/10.3390/vaccines10050775 Text en © 2022 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 Article
Houy, Camille
Ming, Marin
Ettorre, Luciano
Jin, Robbie
Thangavadivel, Nemika
Chen, Tricia
Su, Jin
Gajewska, Beata
Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes
title Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes
title_full Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes
title_fullStr Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes
title_full_unstemmed Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes
title_short Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes
title_sort epitope profiling of diphtheria toxoid provides enhanced monitoring for consistency testing during manufacturing process changes
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9147534/
https://www.ncbi.nlm.nih.gov/pubmed/35632531
http://dx.doi.org/10.3390/vaccines10050775
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