Large Molecules
ITR offers a comprehensive suite of GLP-compliant in vitro and in vivo assays to support the development of large molecule therapeutics, including proteins, nucleic acids, gene therapies, and biologics.
Our expertise spans analytical and bioanalytical methods, immunology, immunogenicity, biodistribution, and immunotoxicology, enabling precise characterization, quantification, and safety evaluation of complex biologics across all stages of preclinical development.
GLP compliant assay types offered at ITR:
- Proteins: Absorbance (UV280), colorimetric (BCA, microBCA), fluorometric (CBQCA).
- Nucleic Acids: Quant-it™ RiboGreen assay.
- ELISA: Quantification via colorimetric, luminescent, and fluorescent methods.
- ECLIA: Electrochemiluminescent assays (Meso Scale Discovery platform).
- Droplet Digital PCR (ddPCR): Single/multiplex (up to 6 targets) for gene therapy concentration in plasma.
- Hybridization ELISA: ddPCR-like application in singleplex format
- In vivo distribution of a variety of innovative therapies, including viral vector-based gene therapies, cell-based immunotherapies, and gene editing therapies.
- Various endogenous biomarkers such as hormones, cytokines or tissue components measured by ELISA (singleplex) or ECLIA (Meso Scale Discovery, singleplex or multiplex).
- Singleplex assays are validated as per GLP
- Up to 10 biomarkers can be multiplexed at once with minimal sample volume (≤ 10 µL).
- Colorimetric, fluorescence or luminescence assays to measure enzymatic activities.
- GLP compliant flow cytometry method using a variety of antibodies binding or not to the test item and its receptor on various immune cell types.
Immunology:
- White blood cell profiling via flow cytometry, including monocytes, T-cells, B-cells, pDCs, neutrophils, and macrophages. Supports phospho-flow and ex vivo analysis.
- GLP-compliant immunophenotyping panels available, with full customization and validation options.
- Cell viability, proliferation and migration assays
- Detection and titration of antidrug antibodies (ADAs), using ELISA or ECLIA.
- Cell-based assays for the detection of neutralizing antibodies (Nab).
- Antibody titration assays for vaccine programs using ELISA or ECLIA.
- T-cell dependent antibody response assays (TDARs) for the detection of specific anti-KLH IgM and IgG antibodies following administration of the Keyhole limpet haemocyanin (KLH) antigen.
- TDARs are validated in both Rat and Monkey.
Equipment:
ELISA (Enzyme-Linked Immunosorbent Assay) is a sensitive method used to detect and quantify specific proteins or antibodies in a sample using antigen-antibody binding and an enzyme-driven signal, often a color change. It is widely used in research and diagnostics for its accuracy and adaptability.
- ECLIA (Electrochemiluminescence Immunoassay) is a highly sensitive technique that uses electrochemically triggered light emission to detect and quantify specific biomolecules, such as proteins or antibodies. It combines antigen-antibody binding with electrochemiluminescent detection for precise and reliable measurement.
- Droplet Digital PCR (ddPCR) is a highly precise method for quantifying nucleic acids by partitioning a sample into thousands of droplets and performing PCR in each one individually. It enables absolute quantification without the need for standard curves, making it ideal for detecting low-abundance targets.
- Flow cytometry is a powerful technique used to analyze the physical and chemical characteristics of individual cells or particles as they pass through a laser beam. It allows for rapid, multiparametric analysis of cell populations, including size, complexity, and marker expression.