Along with extensive experience and scientific expertise, Charles River provides a strategic and consultative-based approach to conducting studies for cellular therapeutics. With focused attention to safety and, as applicable, efficacy aspects, each cellular therapeutic program integrates the most comprehensive scientific and regulatory approaches developed by our multidisciplinary team. The goal of all of our cellular therapy programs is to clearly define any safety issues and, when necessary, place into perspective any risk factors inherent in a cellular therapy product.

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Comprehensive preclinical assessment of stem cell therapies is critical for regulatory approval and to ensure safety in first-in-human clinical trials. Here are some tips for a successful translational cell therapy program.

The Shifting Field of Stem Cell Regulations

Dr. Shawna Jackman, principal research scientist at Charles River discusses the recent FDA hearings addressing concerns around clinics marketing cellular therapies to consumers.

CIRM 2.0: Funding for Translational Research Projects

Charles River entered a collaboration with Quintiles and City of Hope, with funding from the California Institute for Regenerative Medicine (CIRM), to establish the Translating Center in San Diego, CA, which offers end-to-end nonclinical, clinical and manufacturing services for stem-cell-based projects.