The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines
Assaying the potency of inactivated viral influenza vaccines is performed using single radial immunodiffusion, which is the globally accepted release method for potency. Under conditions of a rapidly emerging pandemic, such as the 2009 H1N1 influenza pandemic, a recognized obstacle in the delivery o...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-12-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/11/12/1799 |
| _version_ | 1797379135197151232 |
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| author | Matthew P. Donohue Zhijun Cao Thomas Bowen Robert Dickinson Ying Zhang Jiang Qian |
| author_facet | Matthew P. Donohue Zhijun Cao Thomas Bowen Robert Dickinson Ying Zhang Jiang Qian |
| author_sort | Matthew P. Donohue |
| collection | DOAJ |
| description | Assaying the potency of inactivated viral influenza vaccines is performed using single radial immunodiffusion, which is the globally accepted release method for potency. Under conditions of a rapidly emerging pandemic, such as the 2009 H1N1 influenza pandemic, a recognized obstacle in the delivery of vaccines to the public is the time needed for the distribution of calibrated SRID reagents (antisera and antigen standards) to vaccine manufacturers. Previously, we first described a novel streamlined MS-based assay, CombE-IDMS, which does not rely on antisera/antibodies or reference antigens, as a potential rapidly deployable alternate potency method through a comparison with SRID on adjuvanted seasonal quadrivalent vaccine cell-based (aQIVc) materials. In this report, we further demonstrate that the CombE-IDMS method can also be applied to measure the potency of pre-pandemic H5N1 and H5N8 monovalent vaccine materials, each subtype both unadjuvanted and adjuvanted, through a forced degradation study. Overall, CombE-IDMS results align with those of the gold standard SRID method on both H5N1 and H5N8 materials under conditions of thermal, pH, oxidative and freeze/thaw stress, lending further evidence for the CombE-IDMS method’s suitability as an alternate assay for potency of both seasonal and pandemic influenza vaccines. |
| first_indexed | 2024-03-08T20:17:50Z |
| format | Article |
| id | doaj.art-1fbde3f63a0a404eb7a34cf962b045d2 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-08T20:17:50Z |
| publishDate | 2023-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-1fbde3f63a0a404eb7a34cf962b045d22023-12-22T14:47:11ZengMDPI AGVaccines2076-393X2023-12-011112179910.3390/vaccines11121799The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based VaccinesMatthew P. Donohue0Zhijun Cao1Thomas Bowen2Robert Dickinson3Ying Zhang4Jiang Qian5Biopharmaceutical Product Development, CSL Seqirus, Holly Springs, NC 27540, USABiopharmaceutical Product Development, CSL Seqirus, Holly Springs, NC 27540, USABiopharmaceutical Product Development, CSL Seqirus, Holly Springs, NC 27540, USACSL Limited, Melbourne, VIC 3000, AustraliaBiopharmaceutical Product Development, CSL Seqirus, Holly Springs, NC 27540, USABiopharmaceutical Product Development, CSL Seqirus, Holly Springs, NC 27540, USAAssaying the potency of inactivated viral influenza vaccines is performed using single radial immunodiffusion, which is the globally accepted release method for potency. Under conditions of a rapidly emerging pandemic, such as the 2009 H1N1 influenza pandemic, a recognized obstacle in the delivery of vaccines to the public is the time needed for the distribution of calibrated SRID reagents (antisera and antigen standards) to vaccine manufacturers. Previously, we first described a novel streamlined MS-based assay, CombE-IDMS, which does not rely on antisera/antibodies or reference antigens, as a potential rapidly deployable alternate potency method through a comparison with SRID on adjuvanted seasonal quadrivalent vaccine cell-based (aQIVc) materials. In this report, we further demonstrate that the CombE-IDMS method can also be applied to measure the potency of pre-pandemic H5N1 and H5N8 monovalent vaccine materials, each subtype both unadjuvanted and adjuvanted, through a forced degradation study. Overall, CombE-IDMS results align with those of the gold standard SRID method on both H5N1 and H5N8 materials under conditions of thermal, pH, oxidative and freeze/thaw stress, lending further evidence for the CombE-IDMS method’s suitability as an alternate assay for potency of both seasonal and pandemic influenza vaccines.https://www.mdpi.com/2076-393X/11/12/1799alternate potencyisotope dilution mass spectrometry (IDMS)hemagglutinin (HA)avian influenzaforced degradation |
| spellingShingle | Matthew P. Donohue Zhijun Cao Thomas Bowen Robert Dickinson Ying Zhang Jiang Qian The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines Vaccines alternate potency isotope dilution mass spectrometry (IDMS) hemagglutinin (HA) avian influenza forced degradation |
| title | The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines |
| title_full | The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines |
| title_fullStr | The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines |
| title_full_unstemmed | The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines |
| title_short | The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines |
| title_sort | combe idms alternate potency method for h5n1 and h5n8 cell based vaccines |
| topic | alternate potency isotope dilution mass spectrometry (IDMS) hemagglutinin (HA) avian influenza forced degradation |
| url | https://www.mdpi.com/2076-393X/11/12/1799 |
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