Services 
Immunoassays and Bioassays
MicroConstants develops and validates highly sensitive and specific immunoassays and bioassays to:
- Quantify peptide or protein drugs in various types of formulations and biological matrices
- Assess drug immunogenicity and antidrug antibody (ADA) neutralization activities
- Monitor PK/PD biomarkers
- Evaluate cellular activities
Automated ELISA Validation & Sample Analysis
Using liquid handling and robotic pipetting technologies we are able to automate ELISA methods, avoiding extraction of samples for measurement. This allows us to streamline sample analysis while also providing maximum accuracy, reproducibility, and fast data turnaround times.
Stringent in house immunoassay development and validation processes ensure the highest possible ELISA performance. Additionally, the use of proprietary protocols to orient the antibody on the micro-plate achieves much higher sensitivity compared to passive adsorption. This allows for the analysis of extremely small sample sizes, reducing matrix effects and interference with binding protein(s) or other macromolecules. ELISA protocols can be validated to support preclinical and clinical studies for analysis in a wide variety of matrices.
Custom ELISA Method Development & Validation
For novel protein therapeutics, MicroConstants offers full-service custom immunoassay development and validation services. Our dedicated Immunology Department will design, develop, and validate custom immunoassays using the antibody of your choice, or of commercial origin. If needed, we can also assist with the generation of custom/novel antibodies against your protein therapeutic. Samples from preclinical and clinical studies can be sent to MicroConstants for PK/TK sample analysis.
ELISA Kit Validation & GLP Method Transfer
In addition to custom ELISA development, we will qualify or validate commercially available ELISA/EIA kits for your preclinical or clinical sample analysis needs. We will identify the best available assay kit and evaluate it for compatibility with your peptide or protein. For assays developed in non-GLP laboratories, we can transfer and validate them at MicroConstants under GLP regulations.
Immunogenicity Testing
Addressing the immunogenicity against large molecule drugs has become critical in assessing their long-term safety. To detect and characterize the level of immunogenicity, we evaluate the antidrug antibody (ADA) response of biopharmaceutical products using multi-tiered approaches including ADA prescreening, confirmatory test, and antidrug activity titers.
Neutralization Assays
The most significant function of antidrug antibodies are their ability to neutralize large molecule’s binding to targets, or inhibit their enzymatic activity. We determine the presence of neutralizing antibodies using in vitro binding assays (surrogate neutralization assays), enzyme activity assays, and cell-based functional assays.
Enzymatic Activity Assays
We perform enzymatic activity assays to assess the potency of recombinant enzymes/enzyme inhibitors, monitor PD biomarkers, and measure the ADA neutralization activity against recombinant enzymes.
Biomarker Assays
We are able to develop and validate ELISA immunoassays, LC/MS/MS assays, and multiplexing immunoassays to monitor PD biomarkers such as serum biomarkers, cell surface biomarkers, and intracellular biomarkers.
Cell-based Assays
We can develop and validate cell-based assays to assess the efficacy and cytotoxicity of large molecule drugs, determine cell phenotypes, and to measure neutralization activities of antidrug antibodies.
