Regulatory-Ready Bioanalysis for Cell & Gene Therapy (CGT) Products

Pharmaron offers industry-leading CGT bioanalytical services, ensuring compliance with GLP, GMP, and GCLP guidelines. With over 20 years of regulatory experience and 100+ IND packages supported, our team provides precision bioanalysis for gene therapy, mRNA therapeutics, immunotherapy, and cell-based therapies.

We specialize in PK/TK bioanalysis, biodistribution, viral shedding, and immunogenicity testing, delivering high-quality data to support IND, BLA, and MAA submissions for cell and gene therapy programs.

Key CGT Bioanalytical Capabilities:

• Pharmacokinetics (PK) & Toxicokinetics (TK) – Assessing CGT product distribution and metabolism
• Biodistribution & Viral Shedding Studies – qPCR/ddPCR-based analysis of gene therapy vectors
• Immunogenicity & Potency Assays – ADA, NAb, and T-cell response profiling
• GMP Lot Release & Stability Testing – Ensuring product consistency and regulatory approval
• Advanced Analytical Platforms – qPCR, ddPCR, LC-MS/MS, flow cytometry, ELISA, Western blot

Pharmaron’s state-of-the-art bioanalytical laboratories provide comprehensive CGT testing solutions across discovery, preclinical, clinical, and market phases, helping biotech companies accelerate regulatory approvals and optimize therapeutic development.

Why Choose Pharmaron for CGT Bioanalytical Services?

• Proven Expertise in CGT Bioanalysis – Supporting 100+ IND applications
• Regulatory-Ready Data for IND, BLA, & MAA Submissions – FDA, EMA, and NMPA inspected
• Advanced Analytical Methods for Cell & Gene Therapy – qPCR, ddPCR, ELISA, LC-MS/MS

Ensure your CGT bioanalysis meets global regulatory standards. Download our service overview to explore Pharmaron’s CGT bioanalytical capabilities.