Comparing singlet and duplicate immunogenicity assay in human plasma for pembrolizumab using Gyrolab®
| Autor: | Christopher Smith, Hannah Craig, Johannes Stanta, John Chappell |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Immunoassay
Chromatography medicine.diagnostic_test Chemistry Immunogenicity 010401 analytical chemistry Clinical Biochemistry General Medicine Pembrolizumab Antibodies Monoclonal Humanized 030226 pharmacology & pharmacy 01 natural sciences Method development 0104 chemical sciences Analytical Chemistry 03 medical and health sciences Medical Laboratory Technology Antineoplastic Agents Immunological 0302 clinical medicine Human plasma medicine Humans Singlet state General Pharmacology Toxicology and Pharmaceutics |
| Zdroj: | Bioanalysis. 13:891-900 |
| ISSN: | 1757-6199 1757-6180 |
| Popis: | Aim: For decades, the traditional approach for ligand-binding assays has been to generate two measurements from adjacent wells on the plate. In recent years, scientists have investigated the true benefit of this ‘duplicate analysis’ by looking back at previously generated bioanalytical data with the conclusion that the benefits are negligible. Materials & methods: We demonstrated a method development approach to determine the best number of replicate measurements of an immunogenicity assay. We used an anti-pembrolizumab immunogenicity assay on Gyrolab® to challenge the traditional use of duplicate measurements as we compare it to singlet measurement and show a balanced design for assessing the cut-point in singlet. Results & conclusion: We introduced the concept of calculating the maximum drug tolerance during method development. In this method, we found no practical benefit for duplicate analysis and go further in recommending that singlet analysis should be considered the default for all ligand-binding assays. |
| Databáze: | OpenAIRE |
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