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...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-11-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/10/11/1964 |
| _version_ | 1797463821518897152 |
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| author | Tianjing Hu David F. Miller Amber W. Taylor Christine Riley Caitlin McCormick Keely N. Thomas Rachel Y. Gao Kathy L. Rowlen Emilia B. Byrne Pardeep Kumar Soo Kyung Kim Erica D. Dawson |
| author_facet | Tianjing Hu David F. Miller Amber W. Taylor Christine Riley Caitlin McCormick Keely N. Thomas Rachel Y. Gao Kathy L. Rowlen Emilia B. Byrne Pardeep Kumar Soo Kyung Kim Erica D. Dawson |
| author_sort | Tianjing Hu |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T17:56:10Z |
| format | Article |
| id | doaj.art-5e8d7b170e0940458afd57264c3931d3 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T17:56:10Z |
| publishDate | 2022-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-5e8d7b170e0940458afd57264c3931d32023-11-24T10:17:21ZengMDPI AGVaccines2076-393X2022-11-011011196410.3390/vaccines1011196430-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen CharacterizationTianjing Hu0David F. Miller1Amber W. Taylor2Christine Riley3Caitlin McCormick4Keely N. Thomas5Rachel Y. Gao6Kathy L. Rowlen7Emilia B. Byrne8Pardeep Kumar9Soo Kyung Kim10Erica D. Dawson11InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAPfizer Inc., 875 Chesterfield Pkwy W, Chesterfield, MO 63017, USAPfizer Inc., 875 Chesterfield Pkwy W, Chesterfield, MO 63017, USAR&D Center, EuBiologics Co., Ltd., 125, Wonmudong-gil, Dongsan-myeon, Chuncheon-si 24410, Gangwon-do, Republic of KoreaInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USAPneumonia 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.https://www.mdpi.com/2076-393X/10/11/1964pneumococcal polysaccharide vaccinepneumococcal conjugate vaccineCRM197identity testingantigen quantificationvaccine characterization |
| spellingShingle | Tianjing Hu David F. Miller Amber W. Taylor Christine Riley Caitlin McCormick Keely N. Thomas Rachel Y. Gao Kathy L. Rowlen Emilia B. Byrne Pardeep Kumar Soo Kyung Kim Erica D. Dawson 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization Vaccines pneumococcal polysaccharide vaccine pneumococcal conjugate vaccine CRM197 identity testing antigen quantification vaccine 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 | pneumococcal polysaccharide vaccine pneumococcal conjugate vaccine CRM197 identity testing antigen quantification vaccine characterization |
| url | https://www.mdpi.com/2076-393X/10/11/1964 |
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