CAR-T Cell Therapy Expertise

CAR-T Cell Therapy

CAR-T therapy uniquely engineers a patient’s own immune cells to recognize and attack tumor cells, aiming to deliver targeted responses that conventional therapies cannot match. The Pharmaron team supports CAR-T cell therapy development with comprehensive preclinical services designed to generate the data needed for IND/BLA submissions. From early stage potency assays through analytical CMC, Pharmaron’s teams help researchers build a clear path towards first-in-human (FIH) trials.

Preclinical Significance

Without access to integrated preclinical platforms, fragmented data, extended timelines, and inconsistent study designs are common challenges that can lead to delays and increased costs. A single-source partner covering bioanalysis, pharmacology, safety, and analytical CMC reduces handoff risk and keeps programs on schedule.

Deliverables

• Bioanalytical methods for cell quantification and biodistribution
• Immunogenicity testing with ADA screening and titer determination
• In vivo CAR-T efficacy data with IVIS imaging, tumor volume measurements, and survival analysis
• GLP toxicology covering CRS biomarkers and organ-specific endpoints
• Analytical CMC data packages for identity, purity, potency and stability
• Reporting formatted for IND and BLA regulatory submissions

Why Pharmaron for CAR-T Programs

Pharmaron has supported over 40 CAR-T and gene therapy programs across multiple development stages. Teams at the Exton, Pennsylvania and Boston, Massachusetts laboratories bring experience in both hematologic and solid tumor models. Integrated project management connects bioanalysis, pharmacology, safety and CMC workstreams so sponsors receive coordinated data packages rather than siloed reports.

Learn More

View this service overview to learn how our integrated preclinical services can support your path to IND filing.

References:

• FDA: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products (January 2024)
• EMA: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals – Scientific Guideline
• PMC: Syngeneic Mouse Models for Pre-Clinical Evaluation of CAR T Cells (2024)
• PMC: Clinical Evidence of Immunogenicity of CAR-T Cell Therapies (2025)
• ICH S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals