CGT Bioanalysis

Scientist in safety goggles and mask inspecting a sample vial in a modern lab for CGT bioanalysis services

CGT Bioanalysis

Pharmaron provides end-to-end CGT bioanalysis and support to accelerate advanced therapeutic development across all stages.

  • Extensive bioanalytical support for advanced therapeutics across discovery, preclinical, and clinical stages.
  • Expertise in biodistribution, viral shedding, pharmacokinetics (PK), biomarker analysis, and immunogenicity assays.
  • Proven ability to develop and validate complex bioanalytical methods that meet regulatory standards at all stages of development.
  • Deliver high-quality, decision-enabling data to support IND, BLA, CLIA, IVDR/IDE and global regulatory submissions with confidence.

Capabilities

Analytical Testing Services
Preclinical Studies
CGT in vivo Pharmacology Studies
CGT Bioanalysis
CGT Ophthalmology

Connect with a Scientific Expert
Scientist loading microplate into ddPCR droplet generator with probe oil for biodistribution and viral shedding analysis

Biodistribution and Viral Shedding

We provide critical insights into the behavior, distribution, and efficacy of gene therapies, viral vectors, and cell therapies. Using PCR, ddPCR, and dPCR, we support nonclinical and clinical assay development to assess vector dissemination, persistence, and shedding.

Scientist in lab coat and gloves operating an MSD instrument for immunogenicity assessment CGT bioanalysis in a clinical laboratory

Immunogenicity Assessment

Our Immunogenicity services help address the unique challenges of CGT development by assessing and mitigating immune responses that may affect safety, efficacy, and durability. From ADA assays to T-cell and cytokine profiling, we provide end-to-end testing tailored to your vector, transgene, or cell therapy.

Scientist operating a QIAcuity Four digital PCR system for CGT bioanalysis efficacy biomarker assay development

Efficacy Biomarker Assay

We deliver efficacy and biomarker assessments for CGT programs, from discovery through clinical validation. Using advanced platforms such as LC-MS/MS, PCR, ELISA, and flow cytometry, we generate precise, regulatory-aligned data to measure target engagement, pharmacodynamics, and therapeutic efficacy.

Two Pharmaron scientists in safety goggles and masks collaborating on CGT bioanalysis applications in a laboratory setting

Applications:

  • Experience with multiple matrices: solid tissues of various nature, CSF, blood, serum, plasma
  • Core competency in de novo development and/or transfer of in vitro assays to bioanalytically support the CGT products
  • In-house clinical sample management (LIMS)
  • Electronic Data Management
  • On-site biostatistician support
  • Complementary GxP master and working cell banking capabilities

Contact Our Team

Request more information about our drug discovery, preclinical and clinical development services

Learn More about our Services
A team of scientists in lab coats and safety goggles discuss molecular structures in a cell and gene therapy laboratory. The lead scientist writes chemical formulas on a glass panel, indicating a collaborative effort focused on therapeutic development, analysis, or gene editing processes.