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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics
1Pharmacokinetics and Drug Metabolism, Amgen Inc., One Amgen Center Drive 30E-3-B, Thousand Oaks, CA 91320, USA. jwlee@amgen.com
Bioanalysis
|November 19, 2010
Summary
A fit-for-purpose approach is crucial for biomarker assay validation in protein drug development. This ensures reliable quantification and application, whether exploratory or advanced, for accurate biotherapeutic research.
Area of Science:
- Biotechnology
- Pharmacology
- Analytical Chemistry
Background:
- Protein drug development and biomarker research utilize shared bioanalytical technologies.
- Assays serve distinct purposes in drug development versus biomarker studies.
- A standardized approach is needed for reliable biomarker assay validation.
Purpose of the Study:
- To advocate for a fit-for-purpose strategy in biomarker assay development and validation.
- To guide the selection and validation of bioanalytical methods for protein drug and biomarker studies.
- To highlight the importance of method validation for accurate biomarker quantification.
Main Methods:
- Discusses the characteristics of standard curves for absolute or relative quantification.
- Outlines essential method-validation experiments including parallelism, selectivity, specificity, and stability.
- Emphasizes considering biotherapeutic-target interactions for platform selection and validation.
Main Results:
- Fit-for-purpose validation ensures assays meet specific study needs, from exploratory to advanced applications.
- Appropriate validation prevents confounding data often arising from direct adoption of commercial kits.
- Multiplex assays and physicochemical methods offer complementary approaches to single-analyte assays.
Conclusions:
- A fit-for-purpose approach is essential for robust biomarker assay validation in protein drug development.
- Careful method validation, including kit comparison and modification, is critical for reliable results.
- Diverse bioanalytical technologies can be effectively integrated for comprehensive protein drug and biomarker analysis.
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