Bioanalysis for Macromolecules

MicroConstants develops and validates highly sensitive and specific immunoassays to quantify peptide or protein therapeutics in various types of formulations and biological matrices. Our Immunology Department also assesses drug immunogenicity, evaluates anti-drug antibody (ADA) neutralization activities, and performs toxicokinetic and pharmacokinetic (PK/TK) analysis of biological samples from preclinical, GLP toxicology, and clinical studies.

Immunoassay Method Development, Validation & Sample Analysis

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ELISA Method Development, GLP Validation & Transfer
For novel protein therapeutics, we 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. For assays developed in non-GLP laboratories, we can transfer and validate them at MicroConstants under GLP regulations.

ELISA Kit Validation
We will qualify or validate commercially available ELISA/EIA kits for your preclinical or clinical sample analysis needs. This includes identifying the best available assay kit and evaluating it for compatibility with your peptide or protein.

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. ELISA protocols can be validated to support preclinical and clinical studies for analysis in a wide variety of matrices.

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 anti-drug antibody (ADA) response of biopharmaceutical products using a multi-tiered approach including ADA prescreening, confirmatory assays, and anti-drug activity titers.

Neutralizing Antibody Assays

The most significant function of anti-drug 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) and enzyme activity 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.