التفاصيل البيبلوغرافية
| العنوان: |
Comprehensive performance evaluation of ligand-binding assay–LC–MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442) |
| المؤلفون: |
Huang, Yue, Woolf, Michael Shane, Wang, Chun-Chi, Naser, Sami M, Wheeler, Aaron M, Mylott, William R, Ma, Eric, Rosenbaum, Anton I |
| المساهمون: |
Defense Advanced Research Projects Agency, AstraZeneca |
| المصدر: |
Bioanalysis ; volume 16, issue 7, page 149-163 ; ISSN 1757-6180 1757-6199 |
| بيانات النشر: |
Informa UK Limited |
| سنة النشر: |
2024 |
| الوصف: |
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. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.4155/bio-2023-0225 |
| الإتاحة: |
https://doi.org/10.4155/bio-2023-0225Test |
| رقم الانضمام: |
edsbas.2D5DCB2C |
| قاعدة البيانات: |
BASE |
