Reduce the time and risk in all stages of developing your cell or gene therapy.
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New cell and gene therapy suite
Cell and gene therapies are incredibly intricate, but they’re making a huge difference in the drug development market and in the lives of patients. Learn all about our $9.2 million investment in cell and gene therapy.
Your source for answers to the complex challenges of cell and gene therapy development. We recently sat down with Maryland Franklin, Vice President and Enterprise Head of Cell & Gene Therapy at Labcorp Drug Development, to discuss key considerations for developing cell or gene therapies in today's quickly expanding pipeline.
As the rate of cell and gene therapy development increases, Labcorp Drug Development has continued to invest in the technology, capacity and expertise globally to support the evolving and complex analytical needs of our clients.
The chimeric antigen receptor (CAR) T-cell journey includes three distinct phases: collecting the patient's white blood cells through apheresis, modifying the patient's T-cells to manufacture the CAR T-cells, and, finally, infusing the new fighter T-cells into the patient. Connecting these three phases for a timely process that optimizes the patient experience requires a well-coordinated logistical system.
Chemistry, Manufacturing and Control (CMC) testing is an integral part of the CAR T-cell clinical journey during vector production and T-cell modification. These tests, mandated by the FDA and other regulatory agencies, uphold the safety, purity and potency of the product before being administered to the patient.
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Assess safety, establish proof of concept and feasibility rapidly
Successfully prepare for regulatory agency meetings and IND/IMPD/CTA submissions
Seamlessly transition to first-in-human trials
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FDA approved gene replacement therapies
preclinical studies conducted using cell and gene therapy products in the last 5 years (mostly in vivo)
clinical studies conducted for cell and gene therapy products in the last 5 years
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Cell & Gene Therapy preclinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
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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