Custom Assay Development Capabilities
Whether you need a cell-based assay, host cell protein (HCP) assay, or an immunoassay, our experienced scientists will develop, qualify, validate, and run a custom assay for a range of applications, including:
- Biomarker development
- Pharmacokinetic analysis
- Lot release testing
Assay Qualification, Validation, and Lot Release Testing Capabilities
Assay Qualification
We can demonstrate that an accepted method provides meaningful data for specified conditions.
- Matrix effects
- Process specific samples evaluations
- Suitability of the protocol under actual performance conditions
- Stability study of components and configured assay
- HCP detection in vitro diagnostics development
With our unique strength in antibody generation and development, we can efficiently create novel assays from start to finish by combining our in-house monoclonal and polyclonal antibody generation services with assay development. This synergy enables the generation of all critical assay reagents throughout the assay development process.
Assay Validation
We can conduct a comprehensive evaluation of the quantitative performance of your assay, delivering full documentation and analysis.
Assay development parameters
- LOQ, LLOQ
- Specificity
- Reproducibility
- Matrix effects
Assay validation performance parameters
- Dynamic Range; LOD, LOQ
- Robustness
- Accuracy
- Recovery
- Precision; repeatability, inter-assay variation, reproducibility
- Linearity
Lot Release Testing
We also offer quality control testing on reagents from individual production lots to ensure purity, activity, stability, and performance.
QC testing is available on:
- Raw materials
- Unprocessed bulk
- Purified bulk
- Filled finished products
Contract Manufacturing
We also serve as a contract manufacturing organization with services that include the production of antibody-based and supporting reagents, fully optimized assay kits, or global supply of materials. We manage the raw material, finished product, compliance documentation, and global distribution according to defined parameters established in the quality or supply agreement.