in Cell Therapy
Flow cytometry is a powerful tool that has been increasingly used in clinical trials to assess immunotherapy candidates. Cell-based modalities such as CAR T-cell and CAR NK-cell therapies often utilize flow cytometry to monitor the persistence and differentiation of the cell therapy products and their pharmacology by monitoring target cell depletion. Flow cytometry’s high-throughput analysis of large cell populations with small sample-batch requirements makes it highly attractive for cell and gene therapeutic development and validation, fitting comfortably within the field of bioanalytical assays.
Complexities of cell therapy programs present not only scientific but also technical challenges. They are highly customized and vary greatly based on product attributes, each demanding rigorous regulatory approval. It is therefore crucial to find a partner who offers access to a robust scientific and regulatory network and integrates the various elements of your program to achieve your milestones.
Precision for Medicine can help you navigate challenges with the development of your cell therapy product.
Flow Cytometry Applications in Cell Therapy
Preparing and Characterizing Donor Samples
- Identifying and quantifying cell composition
- Evaluating CAR expression on therapeutic cells
- Validating viability post transfection
Monitoring Therapeutic Effects in Patients
- CAR T-cell/CAR NK-cell persistence and therapeutic effect
- Enumeration and characterization of cell therapy product
- Anti-drug antibodies (ADA) and immunogenicity
- Depletion of a target population by a cell therapy product
- Binding of T cell to the target molecule
— CAR expression at the cell surface
- Tumor infiltration by CAR T-cell/CAR NK-cell, cell therapy product
Assessing Cell Functionality and Potency
- Estimation of effector cell activation
- Measurement of T-cell exhaustion
- Expression of markers of exhaustion
- Expanded phenotypic analysis of marker expression
- Intracellular cytokine expression
Other Flow Cytometry Resources
Values of Precision Flow Cytometry
Established experience running complex flow cytometry in gene therapy, cell therapy, immuno-oncology therapies, validating up to CLIA
Sample testing by flow cytometry staff with >7 years of experience who understand the disease biology and gating strategy
Real-time QC during the run to ensure sample integrity
Additional Specialty Lab Services
Tissue & Liquid Biopsy
Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream® platform, which can isolate and enrich for circulating tumor cells for downstream analysis.
Find and monitor gene expression signatures, copy number variations, chromosome rearrangements, and other genomic events occurring in patient samples using our NGS, NanoString, qPCR, ddPCR, and FISH/ISH services.