Accelerate CAR-T Cell Therapy Development with Pharmaron’s Proven Expertise

Pharmaron offers full-service CAR-T cell therapy development, from preclinical safety and efficacy testing to GMP lot release and regulatory support. Our global team of CGT experts provides IND-enabling studies, bioanalytical assays, and in vivo efficacy models to ensure your CAR-T therapy is clinical trial-ready.

With state-of-the-art GLP/GMP facilities and over 40 CAR-T and gene therapy programs in various development stages, Pharmaron delivers regulatory-compliant data to support First-in-Human (FIH) trials, IND applications, and market approval.

Key CAR-T Cell Therapy Capabilities:

• Preclinical Safety & Efficacy Studies – Evaluation of antigen recognition, persistence, and immune response
• Pharmacology & Toxicology Testing – Tumorigenicity, toxicity, and engraftment studies in immunocompromised models
• Bioanalytical Assays for CAR-T Development – Persistence, potency, and immunogenicity testing
• CMC & GMP Lot Release Testing – Potency assay validation, stability studies, and QC release testing
• Regulatory Support for IND & IMPD Submissions – End-to-end data analysis for FDA and EMA approvals

With expertise in preclinical CAR-T validation, IND submissions, and bioanalytical assay development, Pharmaron ensures regulatory success and clinical trial readiness for next-generation CAR-T therapies.

Why Choose Pharmaron for CAR-T Cell Therapy Development?

• Extensive Track Record in Cell & Gene Therapy – Over 40 CAR-T programs in development
• Regulatory-Ready Preclinical & Analytical Testing – Supporting >30 IND-enabling studies annually
• Advanced Bioanalytical & CMC Expertise – Validated potency assays and GMP lot release testing

Ensure your CAR-T therapy meets regulatory and clinical expectations.  Download our service overview to explore our full range of CAR-T solutions.