Comprehensive performance evaluation of ligand-binding assay-LC-MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442)
Aims: AZD7442 is a combination SARS-CoV-2 therapy comprising two co-dosed monoclonal antibodies. Materials & methods: The authors validated a hybrid ligand-binding assay-LC-MS/MS method for pharmacokinetic assessment of AZD7442 in human serum with nominal concentration range of each analyte of 0.300-30.0 μg/ml. Results: Validation results met current regulatory acceptance criteria. The validated method supported three clinical trials that spanned more than 17 months and ≥720 analytical runs (∼30,000 samples and ∼3000 incurred sample reanalyses per analyte). The data generated supported multiple health authority interactions, across the globe. AZD7442 (EVUSHELD) was approved in 12 countries for pre-exposure prophylaxis of COVID-19. Conclusion: The results reported here demonstrate the robust, high-throughput capability of the hybrid ligand-binding assay-LC-MS/MS approach being employed to support-next generation versions of EVUSHELD, AZD3152.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
Bioanalysis - 16(2024), 7 vom: 26. März, Seite 149-163 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Huang, Yue [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.03.2024 Date Revised 26.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.4155/bio-2023-0225 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368759121 |
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| 100 | 1 | |a Huang, Yue |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Comprehensive performance evaluation of ligand-binding assay-LC-MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442) |
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| 500 | |a Date Completed 26.03.2024 | ||
| 500 | |a Date Revised 26.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Aims: AZD7442 is a combination SARS-CoV-2 therapy comprising two co-dosed monoclonal antibodies. Materials & methods: The authors validated a hybrid ligand-binding assay-LC-MS/MS method for pharmacokinetic assessment of AZD7442 in human serum with nominal concentration range of each analyte of 0.300-30.0 μg/ml. Results: Validation results met current regulatory acceptance criteria. The validated method supported three clinical trials that spanned more than 17 months and ≥720 analytical runs (∼30,000 samples and ∼3000 incurred sample reanalyses per analyte). The data generated supported multiple health authority interactions, across the globe. AZD7442 (EVUSHELD) was approved in 12 countries for pre-exposure prophylaxis of COVID-19. Conclusion: The results reported here demonstrate the robust, high-throughput capability of the hybrid ligand-binding assay-LC-MS/MS approach being employed to support-next generation versions of EVUSHELD, AZD3152 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a hybrid IA–LC–MS/MS | |
| 650 | 4 | |a hybrid LBA–LC–MS/MS | |
| 650 | 4 | |a incurred sample reanalysis | |
| 650 | 4 | |a monoclonal antibody | |
| 650 | 4 | |a pharmacokinetics | |
| 650 | 4 | |a tixagevimab and cilgavimab | |
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| 650 | 7 | |a Ligands |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a Antibodies, Neutralizing |2 NLM | |
| 700 | 1 | |a Woolf, Michael Shane |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Chun-Chi |e verfasserin |4 aut | |
| 700 | 1 | |a Naser, Sami M |e verfasserin |4 aut | |
| 700 | 1 | |a Wheeler, Aaron M |e verfasserin |4 aut | |
| 700 | 1 | |a Mylott, William R |c Jr |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Rosenbaum, Anton I |e verfasserin |4 aut | |
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