Charles River Cell & Gene Therapy

Charles River Laboratories operates a comprehensive drug development and manufacturing platform spanning basic research, discovery, preclinical testing, clinical development, and manufacturing and commercialization. The company provides integrated drug discovery services that reduce time to clinic by up to a year, combining target discovery, hit identification, hit-to-lead, lead optimization, safety, and toxicology under unified project management across therapeutic areas including oncology, neuroscience, and immunology.

The Cell and Gene CDMO division offers end-to-end scalable solutions from early-stage research and testing through commercial release. Biologics testing and manufacturing services support the full biologic development cycle with CGMP-compliant contract manufacturing. The company provides microbiology quality control solutions for contamination control and production acceleration, alongside rapid and compliant microbial testing to optimize QC workflows.

Charles River supports IND-enabling programs with expertise across major therapeutic areas, including medical devices and gene and cell therapies. The company offers scientific and regulatory advisory services to navigate the changing regulatory landscape for pharmaceuticals, industrial chemicals, pesticides, and food/feed applications. One Step Manufacturing provides a comprehensive suite of CRO services in target discovery, lead optimization, development chemistry, GMP, drug product development, and CMC strategy. Fast Lane Paradigm helps expedite IND applications by reducing white space between studies.

The organization has supported 80% of FDA-approved drugs over the past five years and conducted 1,500 IND studies in the last 12 months. It has generated 100 IND submissions containing Retrogenix® platform data supported across FDA, EMA, and PMDA regulatory bodies. Charles River is a 2024 signatory of the United Nations Global Compact and achieved 100% renewable electricity in 2024.