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Cell & Gene Therapies

Developing cell and gene therapies demands deep scientific expertise, specialized capabilities, and a clear understanding of complex regulatory and clinical landscapes. We deliver critical support and insights across the entire development journey - from discovery through commercialization - to help bring transformative therapies to patients faster.

Accelerating Your Cell & Gene Therapy

Bringing cell and gene therapies to life requires more than innovation—it demands a partner with deep expertise, specialized infrastructure, and a commitment to your success.

We provide access to scientific and operational expertise through a global laboratory network supporting all aspects of adoptive cell, regenerative cell and gene therapy:

  • A multidisciplinary team of PhD-level scientists plus operational and program management experts to support critical milestones
  • Global laboratory teams with expertise in critical areas of cell and gene therapy development
  • Robust therapeutic area experience in oncology and rare diseases in emerging target indications like neurology, cardiovascular disease, ophthalmology, immunology and more.

For your program to succeed, it’s vital to have a partner who has the scientific insights across therapeutics areas, real-world data and industry-wide collaborations to manage complex programs.

Why choose Labcorp?

  • Global expertise with a connected lab network supporting over 80% of all FDA-approved cell and gene therapies

  • Flexible partnerships designed to reduce risk and accelerate your path to patients

  • Ongoing investment in innovation, capacity and collaboration to solve your toughest challenges

  • 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

We’re expanding!

Our state-of-the-art preclinical testing facility has added even greater capacity. Now enrolling cell and gene therapy studies for fall 2025

Doctor or nurse in a laboratory preparing a vaccine for a patient.


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

Whether you're just beginning or advancing toward commercialization, we’re here to support your cell and gene therapy journey. From discovery to preclinical studies, clinical trials and long-term follow-up, our integrated testing solutions are built to move with you—every step of the way.

Discovery

Accelerate your program with specialized technologies and deep experience across a wide range of cell- and gene-based platforms:

  • Deep expertise in CAR T and other cell therapies to accelerate early screening and development
  • Advanced tools for AAV and viral capsid evaluation, including molecular biology and imaging
  • On-site gene-modified cell therapy production and in vitro services (flow cytometry, IHC, ddPCR, MSD)
  • 300+ tumor models, including luciferase-expressing lines, for robust in vivo studies
  • AAV capsid evolution strategies and immunosuppressant combination studies
  • Specialized ocular studies for safety, PK, and efficacy in collaboration with OSOD
Doctor or nurse in a laboratory preparing a vaccine for a patient.

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
Doctor or nurse in a laboratory preparing a vaccine for a patient.

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
Doctor or nurse in a laboratory preparing a vaccine for a patient.

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
Doctor or nurse in a laboratory preparing a vaccine for a patient.


Cell and gene therapy answers series: Your source for answers to the complex challenges of cell and gene therapy development.

 Cell and Gene Therapies

Cell and gene therapy answers

Want to learn more about Labcorp cell and gene therapy solutions?