Custom Assay Development
Categories
Move confidently from discovery to product in comprehensive assay development and implementation services - together with antibodies-online and our partner Rockland Immunochemicals, Inc. (Rockland). Our experienced scientists can customize a project to meet your needs, whether you’re conducting basic, discovery, pre-clinical, or clinical research.
Immunoassay Development
Advance confidently with immunoassay development and implementation services from the antibody experts at antibodies-online and Rockland. Through decades of experience developing and running thousands of immunoassays we have optimized processes that maximize success.
HCP Assay Development
Maximize efficiency by combining host cell protein (HCP) antibody generation with HCP assay development from the proven team of antibodies-online and Rockland. With over 12 years of experience developing HCP antibodies and assays, we understand what’s needed for success.
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.
Our Service Partner: Rockland
Our Service Partner: Rockland
Benefit from expertise over two generations of scientific advances. Rockland enabling biomolecule detection, characterization and analysis since 1962. 60,000 square feet manufacturing facility produce high-quality antibodies, reagents and custom services for your next project
Benefit from expertise over two generations of scientific advances. Rockland enabling biomolecule detection, characterization and analysis since 1962. 60,000 square feet manufacturing facility produce high-quality antibodies, reagents and custom services for your next project
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.
