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Customised flow cytometry solutions

Engage assay experts with extensive experience and expertise

Full service assay development

Given the cost, time and expertise needed to develop and qualify robust internal capabilities in flow cytometry, a partner with the scientific expertise, global resources and mission commitment can help sponsors effectively develop and uniformly execute flow cytometric assays.

ICON has distinguished itself within the clinical trials industry through its specialised Flow Cytometry solutions. Our full-service offering begins with early collaboration with the sponsor’s scientific team to gain a thorough understanding of the testing methods and parameters required. We provide industry recognised research and development services to support technology transfers, assay development and validation via an extensive biomarker test menu and standardised analyses to monitor key molecules, targets and receptors. Our innovative and interconnected global flow cytometry network provides a central data repository and facilitates consistent result interpretation.
 

We work with sponsors to:

  • Develop and/or optimise flow cytometry methodology to meet the required specifications for monitoring therapeutics
  • Provide the sponsor with validation data for approval
  • Rollout flow cytometric assays globally as required
  • Develop a customised standard operating procedure (SOP) for performing assays globally
  • Collaborate with the sponsor regarding special requirements, including secure transfer of listmode and data analysis files
  • Utilise mature operational processes that optimise the sponsor’s requirements
  • Precisely define the specifications for result reporting

We have expertise in using a variety of instrumentation platforms, developing and validating a broad range complex flow cytometric assays under rigorous quality control procedures. Dedicated operational staff perform ongoing clinical trial sample processing and analysis using standardised SOPs and data analysis strategies.

 

Global flow cytometry network

Our global flow cytometry network has laboratory locations in New York, Dublin and Singapore, and all instruments are connected to a central flow cytometry server. Having a central server allows us to utilise fully harmonised and standardised processes and instrumentation for even the most complex assays. This network enables mature processes for developing, validating and implementing complex flow cytometric assays globally.

 

Complex flow cytometry assays

ICON has the resources and scientific expertise to implement a broad range of custom flow cytometric assays in clinical trials. 

Types of flow cytometric assays that are developed/validated at ICON include:

– Receptor occupancy assays, customised per drug
– Antibody-dependent cell-mediated cytotoxicity assays
– Rare event enumeration (myeloid-derived suppressor cells, dendritic cell subpopulations, blasts)
– Ultra-rare event enumeration (circulating tumor cells, tetramer assays for antigen-specific T lymphocytes)
– T cell maturation phases (naïve, central memory, effector memory)
– B cell maturation phases (naïve, switched memory, unswitched memory, double negative)
– In vitro stimulation and quantification of intracellular cytokines (IL-2, -4, -5, 13, -17, γ-IFN)
– Intracellular small molecule measurement (antibody- drug-conjugate) correlating to relative amount of drug delivered per cell
– Phosphorylation assays (NF-kB, p38)
– Microbead-based enrichment of T lymphocytes, B lymphocytes, granulocytes, monocytes and disease-state immune cells
– Basophil, eosinophil assays
– Custom research use only flow cytometric assay approved by New York State Department of Health for use as a clinical diagnostic assay to support patient enrolment
– Flow cytometric assays to support companion diagnostics


 

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