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Cell & Stem Cell Therapies

Integrated Molecular & Immunology Analytics for Cell Therapy and Stem Cell Programs

From CAR-T cell therapy analytics and TCR-T monitoring to mesenchymal stem cell (MSC) and iPSC potency testing, cell-based therapeutics require highly specialized assays to track persistence, phenotype, potency, and safety.

Accelevir delivers GLP cell therapy testing, flow cytometry immune profiling, and vector copy number (VCN) assays to support both autologous and allogeneic platforms.

Challenges in Cell & Stem Cell Therapy Development

  • Persistence tracking: Measuring modified or transplanted cells over time.
  • Phenotypic characterization: Defining functional and differentiation states.
  • Potency confirmation: Demonstrating functional activity in vitro or ex vivo.
  • Safety monitoring: Detecting tumorigenicity, vector-related risks, and immunogenicity.
  • Regulatory compliance: Meeting global standards for cell-based product testing.

How Accelevir Supports Cell Therapy Programs

  1. Persistence & Engraftment Monitoring
  • qPCR/dPCR for vector copy number or cell-specific genetic markers.
  • Longitudinal tracking in blood, tissue, and bone marrow.
  1. Phenotypic Profiling
  • Multiparameter flow cytometry for lineage, activation, memory, and exhaustion markers.
  • Stem cell surface marker panels (CD34, CD73, CD90, CD105, etc.).
  1. Functional Potency Assays
  • Cytolytic assays for engineered immune cells (CAR-T, NK cells).
  • Cytokine secretion profiling via multiplex platforms.
  • Differentiation assays for stem cells.
  1. Safety & Tumorigenicity Testing
  • Molecular assays for vector integration patterns (for gene-modified cells).
  • Karyotyping/NGS (via partners) for chromosomal stability.
  1. Immunogenicity Assessment
  • ELISpot/ICS for immune responses against engineered or donor-derived cells.
  • Cytokine profiling for inflammation and rejection risk.

Why Partner with Accelevir

  • Experience with both immune cell therapies and regenerative medicine.
  • Integrated molecular + cellular readouts from a single lab.
  • CLIA-certified, GLP-ready workflows supporting global regulatory filings.
  • Expertise in both autologous and allogeneic cell therapy platforms.
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