Immunological assays are key tools for almost all advanced vaccine and therapeutics. Clinical immunological assays are required for any therapeutic that could potentially trigger an immune response compromising the patient’s safety. We support our customers performing the immune monitoring analysis after treating with therapeutics assessing the immunogenicity triggered by the treatment and correlating it with the clinical outcomes.
Our hLAB offers vast and complex customized solutions for biomarker analysis through the development and validation of laboratory assays that allow the quantification and characterization of immune responses in clinical trials. Pharmacodynamics data resulting from the biomarker services provides a valuable tool to determine and confirm the mechanism of action and/or the target engagement of the therapeutic mitigating the risk at key stages of drug development.
The biomarker endpoints available are:
Multiplex cytokines and chemokines analysis
The simultaneous detection of different levels of cytokines is conducted using the MSD platform. The advantages of this platform are:
The ELISpot is a highly sensitive immunoassays that measure the frequency of antigen-specific T cells by measuring the number of cytokine-secreting cells within the blood at a single cell level. The enumeration of biologically active, cytokine-secreting cells from isolated PBMCs is typically performed as follows:
