Multiparameter Flow Cytometry
Monitoring with Flow Cytometry provides a range of diverse information about immune and non-immune cellular (sub)populations and their activation status. This is achieved by exploiting a panel of antibodies coupled with different fluorescence dyes, which bind to specific biomarkers on a particular cell type. This technology provides sophisticated multi-parameter targeted proteomics data at the single cell level and in high-throughput.
Various flow cytometry assays can be applied to preclinical and clinical studies accompanying the development of new immunotherapeutics:
- to comprehensively monitor changes in immunophenotypes by subset distribution analysis,
- to track changes in surface markers or intracellular cytokines to observe activation of immune cells, or
- to measure the binding of a compound to a receptor for on-target and off-target cell subsets using a receptor occupancy assay.
This allows one to answer questions with respect to Safety, Pharmacodynamics, Pharmacokinetics and Mode-of-Action.
What we can add to your research
We have long-standing experience in developing multi-colour Flow Cytometry Panels for various cell populations and receptor occupancy in whole blood and tissue samples or in vitro cell cultures. We can offer a wide range of already validated Flow Cytometry panels as well as the development of any sponsor specific requirements or new requests. We offer advice and support to develop such Flow Cytometry Panels according to EMA/FDA guidelines.
- Advice on selection of panels and marker combinations for specific needs
- Validated ready-to-go off-the-shelf assays
- Development of new Multi-Colour Flow Cytometry panels or transfer of sponsor-developed assays
- Validation of Flow Cytometry panels
- Stratification of selected panels and biomarkers in patient groups
- Sample measurement and cytometric data analysis
Assay development and Validation Strategy:
- Selection of marker combination together with sponsor
- Titration of fluorescence labeled antibodies
- Setting of compensation and FMO controls
- Precision assessment
- Intra-assay (within assay) variances
- Inter-assay (between assays) variances
- Inter-Operator variances
- Robustness assessment
- Age of Blood determination
- Assessment of marker stability in stabilized biosamples (BCT whole blood, frozen whole blood, or frozen PBMCs)
IVD devices for clinical studies:
- More than 20 off-the-shelf validated panels
- Customized panel design
- Detecting immune cell subsets
- Functional assays
- Receptor occupancy
- adhoc data generation via LIMS in short time