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Specialized scientific experience to accelerate your cell therapy program

Key insights and customized support to minimize potential risks

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Comprehensive global experience supporting of 6 FDA-approved CAR T-cell therapies

Novel platforms and approaches critical to advanced therapy development, including NGS, single-cell sequencing, digital spatial profiling and mass cytometry

Focused preclinical discovery and precision oncology product portfolio for solid tissue, liquid biopsy, and immune profiling

A partner for your adoptive cell therapy testing needs—wherever you are in development

Adoptive cell therapies (ACTs) can deliver transformative approaches to patient care. Whether you are working with tumor-infiltrating lymphocytes, gene-modified T-cells expressing novel T-cell receptors, chimeric antigen receptor T-cells (CAR T) or CAR natural killer cells, we can support your laboratory assessments across the entire development continuum.

  • Discovery/Preclinical

    In vitro analysis

    • Transduction efficiency (flow cytometry)
    • Cytotoxicity analysis and multiplex release assays
    • PBMC subset isolation and cell activation
    • Cell-based functional assays
    • Karyology
    • Tissue cross-reactivity

    Pharmacodynamic (PD) response/efficacy

    • Oncology models for PD/efficacy
    • ACT tumor infiltration by immunohistochemistry
    • Broad-scale gene expression profiling (RNA-Seq NanoString)
    • Flow cytometry analysis, immunoassay and VCN measurement

    Toxicology and safety assessment

    • GLP tumor/non-tumor-bearing in vivo studies (multiple species)
    • GLP formulation, dose analysis, administration
    • Biodistribution and persistence by flow cytometry, qPCR or ddPCR
    • Histopathology and IHC
    • Cytokine/chemokine analysis: multiplexed immunoassays
    • Clinical Pathology (e.g., clinical chemistry, hematology)
    • Toxicology for Phase I doses 

  • GMP CMC Release

    Critical quality attributes

    • Vector copy number, titer and viability
    • Potency and biological activity
    • Safety and RCL/RCR
    • Purity and impurities
    • Identity
    • Stability

  • Clinical Trial Testing

    PD response/efficacy

    • Cell persistence and expansion by qPCR/ddPCR and flow cytometry
    • Tumor and immune cell profiling
    • Immunophenotyping by flow cytometry (T-cell lineage, B-cells, memory T-cells, Treg)
    • ELISpot analysis
    • IHC, NanoString DSP
    • Gene expression profiling (NanoString, RNA-Seq, NGS)
    • T-cell clonality
    • Minimal residual disease assessment (flow cytometry, NGS)
    • PD effect on cytokines, chemokines and growth factors (Luminex, MSD, Quanterix, ELISA)

    Safety

    • Cytokine release syndrome-mediated cytokine and inflammatory
      mediators by multiplexed immunoassay approach (Luminex, MSD)
    • Karyotype
    • RCR/RCL by PCR

    Target identification and patient selection/predictive biomarkers

    • Target antigen expression by IHC or gene expression
    • HLA analysis
    • Transcriptomic analysis and signature definition for evaluating tumor microenvironment and immune function (OmniSeq Insight)
    • Mutational and epigenetic analysis by NGS 

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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.

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