Preclinical CGT Services: Advancing Cell and Gene Therapies from Discovery to Clinic
Accelerating Breakthroughs with Integrated Cell Therapy Services and Gene Therapy Services
Pharmaron delivers a comprehensive suite of preclinical CGT services designed to help developers of advanced therapies move confidently from discovery through IND-enabling studies and into clinical development. With expertise across gene therapy services, cell therapy services, and analytical testing, Pharmaron provides scientific and regulatory support tailored to complex therapeutic platforms including CAR-T, AAV, and other viral and non-viral vector systems.
Why Preclinical CGT Services Matter:
The path to clinic for cell and gene therapies requires specialized preclinical support, including:
- GLP toxicology studies with disease-specific models
- Biodistribution and persistence assessments
- Immunogenicity, cytokine, and biomarker analysis
- Advanced imaging, electrophysiology, and neurobehavioral endpoints
- Dose route optimization (IV, intrathecal, intravitreal, intracerebral, etc.)
Pharmaron’s global platform includes a wide range of animal species (including NHPs), advanced delivery capabilities (e.g. stereotaxic CNS injections), and in-house analytical services spanning qPCR, ddPCR, LC-MS/MS, ELISA and flow cytometry.
Capabilities
End-to-End Gene Therapy Services with Regulatory-Grade Support
Pharmaron’s gene therapy solutions support the full spectrum from vector design and GMP manufacturing to CMC dossier support.
Capabilities include:
- Potency, purity, identity and infectivity assays
- Genome titration, residuals analysis, and replication-competent assays
- Custom assay development with regulatory validation (GLP, GCLP, CLIA)
Expert Cell Therapy Services Backed by Scalable Infrastructure
For clients developing CAR-T or other cell-based therapies, Pharmaron offers:
- Cell bank generation and qualification
- Custom cytotoxicity, cytokine release, and immune activation assays
- Support for CLIA and GMP compliance across platforms
Resources:
Why Pharmaron? | Value Across the CGT Lifecycle
Whether you need biodistribution studies, viral vector production, or full CMC support, Pharmaron’s preclinical CGT services platform enables efficient, compliant progression to clinic.
Download the brochure to explore how our services accelerate development while meeting regulatory expectations.