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We can assess how modulation occurs across common matrices:
Therapeutic immunology
Immunotherapy is the intentional modulation of the immune system to reach a specific therapeutic goal. Through enhancing or suppressing immune response, immunotherapeutic drugs can have a pronounced effect on disease activity within the body.
Immunology and Immunotoxicology supports the evaluation of intended Test Article interactions with the immune system
Flow Cytometry, Immunoassay, and cell-based assays designed to fit your program’s needs
Whole blood/peripheral blood cells
- Immunophenotyping
- Receptor occupancy
- Intracellular cytokine staining
- PBMC Isolation
- Cytokine release assay
- Custom immunophenotyping
Plasma and serum
- Cytokine assessment
- Antigen-specific antibody assessment
- Complement assessment
- Immunoglobulin isotyping
- Custom biomarker analysis
Primary cells/cell lines/cell-based test article
- Primary cell culture
- Immunophenotyping
- Cell-based test article characterization
- Intracellular cytokine staining
- Cytokine release assay
- ELISPOT
- NK-cell killing assay
- Custom cell based assays
It is vital to completely define and understand the safety profile of how your therapeutic immunomodulator alters immune activity at a preclinical stage.
Small molecules
Including: tyrosine kinase inhibitors, GPCR inhibitors, receptor agonist, enzyme inhibitors, proteasome inhibitors, apoptosis pathway inhibitors
We support your program through:
- cytokine production
- immunophenotyping
- global assessment of immune function
Large molecules
Including: immune cell depletion, cytokine neutralizer, bi-specific antibodies, tri-specific antibodies, immune oncology applications
We support your program through:
- cytokine production
- immunophenotyping
- cytokine release assays
- global assessment of immune function
- bone marrow characterization
Advanced therapies
Including: CAR-T cells, artificial APCs, lipid nanoparticles, AAV-based therapies
We support your program through:
- cell handling
- NK-cell killing assay
- cytokine production
- immunophenotyping
- global alterations to immune response
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Regulatory
Working with Labcorp means working with a partner with extensive experience of running therapeutic immunology studies across all classes of drugs. We use this experience to design the correct set of assays for your program and can run assays in non-GLP or fully GLP formats.
Characterization of cell-based test articles is critical for obtaining regulatory approval for new cell therapy entities. In this rapidly evolving therapeutic field, characterization often needs to be more thorough than what is indicated in current advanced therapy guidance. Labcorp I&I has extensive experience characterizing cell-based therapeutics to ensure regulatory needs are met, including applying principals of strength, purity, concentration, identity, and stability to cell-based test articles.
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Labcorp is a leading global life sciences company that includes contract research and developmental services to the pharmaceutical, medical technology, crop protection and chemical industries.