Cell & Gene Therapies

Cell & Gene Therapies

From research and development of cell and gene therapy products to next gen sequencing testing in the clinic, our scientists are finding answers.

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Cell Therapies Gene Therapies Expert Teams Immuno-Oncology Biomarkers Cell & Gene Therapy Education Center

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Global laboratory resources you need at every stage of cell & gene therapy product development

We’re here to offer support no matter where you are in your cell and gene therapy program or where you intend to go. From discovery through clinical trials and long-term follow-up, we offer a comprehensive suite of testing solutions that span the entire development continuum.

  • Discovery

    Extensive CAR T-cell and other cell-based therapy experience and technologies to enable early product screening and future development

    • Molecular biology and imaging technologies for assessing novel engineered adeno-associated viruses (AAVs) and other viral capsids
    • On-site gene-modified cell therapy production and advanced in vitro services by flow cytometry, IHC, ddPCR, MSD
    • Multiple-modality imaging capabilities
    • More than 300 solid tumor and hematologic malignancy models (more than 100 luciferase expressing)
    • Combinatorial immunosuppressant therapy studies
    • AAV Capsid-directed evolution strategies for evaluating diverse capsid libraries and variants with desired tropism in in vivo models
    • Ocular safety assessment, PK, and efficacy studies in partnership with OSOD

  • Nonclinical Studies

    Comprehensive safety toxicology, tumorigenicity, biodistribution, analytical testing and data support for investigational new drug (IND)/investigational medicinal product dossier/clinical trial application submissions

    • Unique animal models requiring complex methods and routes of administration
    • Large-and small-animal model stereotaxic delivery (e.g., magnetic resonance imaging, intracranial volume)
    • Phase-appropriate assay development for chemistry, manufacturing and control (CMC) regulatory expectations
    • Emerging pluripotent-derived cell experience
    • Key therapeutic area support (e.g., ocular, neurodegenerative and oncology)

  • Clinical Trial Testing

    Decision-enabling data to support the preparation and filing of biologics license application/marketing authorization application and other submissions

    • Proprietary data set with unique insights from diagnostic test data, clinical trial data and direct patient access
    • Comprehensive analytical and biomarker testing, including bespoke assay development, validation and implementation through a global laboratory network
    • CMC assay development, optimization and validation
    • Central analytical lab to remove risk of analytical variation or bias from multiple CDMO/analytical partners—from drug development to commercialization to enable bespoke, comprehensive and independent assessment of product quality

  • Registrational Trial and Long-Term Follow-Up Testing

    Full-service testing support for extended long-term follow-up

    • Parallel development of therapeutic and diagnostic and CDx commercialization
    • Decentralized laboratory sample collection solutions to decrease patient burden and optimize engagement
    • CMC commercial batch release of marketed products

Interested in next gen sequencing (NGS)? 

Discover how we are using NGS to make a difference for cancer patients. 

NGS for cancer
There is a gap between the number of patients needed to participate in new cancer trials and the number who give consent to take part. Decentralized clinical trials (DCTs) are helping to address this gap by increasing the reach of clinical studies beyond conventional research sites. DCTs provide an opportunity to remove some of the burdens associated with in-clinic visits, allowing participants to take part in trials from their own homes and/or community healthcare setting, with fewer visits to hospital/trial site. Key to the delivery of DCTs is a suite of tools and technologies that support near real-time review of clinical data from multiple sources. This article looks at some of the technologies, tools and processes that can support more patient-centric oncology trials.

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Proven expertise for cell and gene products

Scientific and operational experience with a global laboratory network supporting all aspects of cell and gene therapy development

Tailored engagement models to reduce time and risk, helping you bring new therapies to patients faster

Sustained investment in partnerships, capabilities and capacity to provide you with cutting-edge solutions for your development challenges

LABCORP CELL AND GENE THERAPY SOLUTIONS

Providing you the laboratory expertise and global scale you need—with the personalized experience you deserve.

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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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