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30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
Pneumonia accounts for over 20% of deaths worldwide in children aged 1 to 5 years, disproportionately affecting lower- and middle-income countries. Effective, highly multivalent pneumococcal vaccines are available to decrease disease burden, with numerous new vaccines currently under development to...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693921/ https://www.ncbi.nlm.nih.gov/pubmed/36423058 http://dx.doi.org/10.3390/vaccines10111964 |
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author | Hu, Tianjing Miller, David F. Taylor, Amber W. Riley, Christine McCormick, Caitlin Thomas, Keely N. Gao, Rachel Y. Rowlen, Kathy L. Byrne, Emilia B. Kumar, Pardeep Kim, Soo Kyung Dawson, Erica D. |
author_facet | Hu, Tianjing Miller, David F. Taylor, Amber W. Riley, Christine McCormick, Caitlin Thomas, Keely N. Gao, Rachel Y. Rowlen, Kathy L. Byrne, Emilia B. Kumar, Pardeep Kim, Soo Kyung Dawson, Erica D. |
author_sort | Hu, Tianjing |
collection | PubMed |
description | Pneumonia accounts for over 20% of deaths worldwide in children aged 1 to 5 years, disproportionately affecting lower- and middle-income countries. Effective, highly multivalent pneumococcal vaccines are available to decrease disease burden, with numerous new vaccines currently under development to serve a variety of worldwide markets. However, pneumococcal conjugate vaccines are among the hardest biologics to manufacture and characterize due to their complexity and heterogeneity. Current characterization methods are often inherently singleplex, requiring separate tests for each serotype present. In addition, identity and quantity are often determined with separate methods. We developed the VaxArray pneumococcal assay for applications in identity, quantity, and stability testing of pneumococcal polysaccharide and pneumococcal conjugate vaccines. The VaxArray pneumococcal assay has a time to result of less than 30 min and is an off-the-shelf multiplexed, microarray-based immunoassay kit that can identify and simultaneously quantify 23 pneumococcal polysaccharide serotypes common to many on-market and in-development vaccines. Here, we highlight the potential of the assay for identity testing by showing high reactivity and serotype specificity to a wide variety of native polysaccharides, CRM197-conjugated polysaccharides, and drug product. The assay also has vaccine-relevant lower limits of quantification in the low-to-mid ng/mL range and can be used for accurate quantification even in adjuvanted vaccines. Excellent correlation to the anthrone assay is demonstrated, with VaxArray resulting in significantly improved precision over this antiquated chemical method. |
format | Online Article Text |
id | pubmed-9693921 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-96939212022-11-26 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization Hu, Tianjing Miller, David F. Taylor, Amber W. Riley, Christine McCormick, Caitlin Thomas, Keely N. Gao, Rachel Y. Rowlen, Kathy L. Byrne, Emilia B. Kumar, Pardeep Kim, Soo Kyung Dawson, Erica D. Vaccines (Basel) Article Pneumonia accounts for over 20% of deaths worldwide in children aged 1 to 5 years, disproportionately affecting lower- and middle-income countries. Effective, highly multivalent pneumococcal vaccines are available to decrease disease burden, with numerous new vaccines currently under development to serve a variety of worldwide markets. However, pneumococcal conjugate vaccines are among the hardest biologics to manufacture and characterize due to their complexity and heterogeneity. Current characterization methods are often inherently singleplex, requiring separate tests for each serotype present. In addition, identity and quantity are often determined with separate methods. We developed the VaxArray pneumococcal assay for applications in identity, quantity, and stability testing of pneumococcal polysaccharide and pneumococcal conjugate vaccines. The VaxArray pneumococcal assay has a time to result of less than 30 min and is an off-the-shelf multiplexed, microarray-based immunoassay kit that can identify and simultaneously quantify 23 pneumococcal polysaccharide serotypes common to many on-market and in-development vaccines. Here, we highlight the potential of the assay for identity testing by showing high reactivity and serotype specificity to a wide variety of native polysaccharides, CRM197-conjugated polysaccharides, and drug product. The assay also has vaccine-relevant lower limits of quantification in the low-to-mid ng/mL range and can be used for accurate quantification even in adjuvanted vaccines. Excellent correlation to the anthrone assay is demonstrated, with VaxArray resulting in significantly improved precision over this antiquated chemical method. MDPI 2022-11-19 /pmc/articles/PMC9693921/ /pubmed/36423058 http://dx.doi.org/10.3390/vaccines10111964 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 Hu, Tianjing Miller, David F. Taylor, Amber W. Riley, Christine McCormick, Caitlin Thomas, Keely N. Gao, Rachel Y. Rowlen, Kathy L. Byrne, Emilia B. Kumar, Pardeep Kim, Soo Kyung Dawson, Erica D. 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization |
title | 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization |
title_full | 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization |
title_fullStr | 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization |
title_full_unstemmed | 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization |
title_short | 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization |
title_sort | 30-minute highly multiplexed vaxarray immunoassay for pneumococcal vaccine antigen characterization |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693921/ https://www.ncbi.nlm.nih.gov/pubmed/36423058 http://dx.doi.org/10.3390/vaccines10111964 |
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