Flow Cytometry Overview - ICON plc

Service Overview
Cytometry
Central Laboratories
Cytometry Solutions
ICON Central Laboratories is distinguishing itself within the clinical trials industry through our specialized
ICON Cytometry Services, which offers two levels of client support: Full Service collaboration to develop
specific assays for biologic therapies; advanced level Monitoring of Fully Validated Standardized Assays.
Full Service Assay Development
The Full Service offering begins with early
collaboration with clients to develop specific assays
for biologic therapies. ICON provides industry
recognized Research and Development services to
support technology transfers, assay development
and validation via an extensive test menu, including
biomarkers and analyses to monitor key molecules, targets and receptors. Our innovative Global Flow
Cytometry Network provides a central data repository and facilitates consistent result interpretation.
With our Full Service offering, ICON’s scientific team meets with the client’s senior scientists to gain a thorough
understanding of the testing methods and parameters required.
ICON works with our clients to:
• Develop the flow cytometry methodology to the required specifications;
• Obtain appropriate material from a reputable supplier of disease-specific specimens so that split
sample comparisons can be performed;
• Provide the sponsor with validation data for approval;
• Develop a sponsor-approved, customized standard operating procedure (SOP) for performing
their assay(s);
• Collaborate with the sponsor regarding special requirements, including transfer of listmode files
and data plots analysis;
• Provide flexible operational working models that optimize their requirements.

Monitoring of Fully Validated Standardized Assays
Clients may also choose to use ICON Cytometry Solutions at a more advanced
stage of clinical development. The Monitoring of Fully Validated Standardized
Assays provides, support for large scale, high volume requirements of later
phase, global clinical trials, such as B cells, T Regulatory cells, leukemic assays,
lymphocyte subsets including naïve and memory cells involved in autoimmune
diseases.
Rigorous quality control is an important part
of ICON Cytometry Services
ICON’s quality control program includes:
• Utilization of six- and eight-color instrumentation;
• Use of same lot number or custom preparation of antibody reagents to
maintain consistency of data;
• Thorough training of all laboratory personnel performing the test to ensure
strict compliance with the SOP;
• Use of beads, human cells and cRBCs for consistent calibration of fl ow cytometers across all locations;
• Two levels of laboratory review and confi rmation prior to releasing test results.
ICON has global fl ow cytometry testing laboratories located in New York, Dublin and Singapore and all instruments are
connected to a central fl ow cytometry server. In addition, secure access to client-specifi c FTP servers may be established
allowing review of raw data and test results.
To further assist in standardization and quality control of fl ow cytometric data which is generated in the central laboratory
environment, ICL has created a virtual fl ow cytometry network that provides a central repository of such data and reduces
reader subjectivity that can be a concern in studies involving fl ow cytometry assays.
For more information on ICON Cytometry Solutions, or any of our central laboratory services,
please contact: www.iconplc.com, or email us at labinfo@iconplc.com.
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