Bioanalysis for Macromolecules

Immunoassays and enzymatic assays using MSD, ELISA, and Luminex for pharmacokinetic and immunogenicity development, including for neutralizing antibodies

MicroConstants develops and validates highly sensitive and specific immunoassays to quantify peptide or protein therapeutics in various types of formulations and biological matrices. Macromolecules include biomarkers and large molecule drugs including therapeutic biologics like antibodies, cytokines, and other recombinant therapeutic proteins and peptides (e.g., erythropoietin, growth hormones, fusion proteins). Biologics are complex molecular entities produced in biological systems (e.g., human, animal, microorganisms). This contrasts with small molecule drugs (<900 daltons), which are generally produced by chemical synthesis (e.g., acetaminophen and lidocaine). Our Immunology Department also assesses vaccine and drug immunogenicity, including binding and neutralizing anti-drug antibody (ADA) 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

close up of development instruments

Immunoassay Method Development, Method Transfers, GLP Validation & Non-GLP Method Qualifications
MicroConstants excels at method development using a variety of assay formats including Meso Scale Discovery (MSD), ELISA/EIA, Luminex, among other technologies based on ligand-binding methods. 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. MicroConstants also offers immunoassay method qualifications, an assay characterization procedure with less rigor than the full GLP validation protocol, but with less expense for those situations where a fit-for-purpose approach would be optimal.

Immunoassay Kit Validation
We will qualify or validate commercially available ELISA/EIA, bead (Luminex technology), and MSD 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 Immunoassay Validation & Sample Analysis
Using liquid handling and robotic pipetting technologies we are able to automate methods like ELISA and MSD, 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 assay performance to ensure maximal sensitivity, precision, and accuracy in biologic matrices and formulations. We are experienced with a wide variety of fluid and tissue matrices, experience that can be translated to support virtually any preclinical and clinical studies bioanalytical objective.

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. Established strategies are used to ensure high sensitivity and high drug tolerance in either a direct binding or bridging format with MSD or ELISA, depending on client preference.

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.

  • Custom Immunoassay method development & validation
  • Commercially available Immunoassay kit validation
  • Automated Immunoassay validation & sample analysis
  • Immunogenicity testing
  • Neutralizing antibody assays
  • Enzymatic activity assays

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