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Flow Cytometry

The increasing complexity of emerging therapeutic candidates has created new challenges in conducting clinical trials for precision medicine. New high tech laboratory testing is required, such as custom flow cytometry, which is the gold standard cell analysis technology.

 

ICON has the scientific expertise to implement a broad range of flow cytometric assays in clinical trials. We cultivate a partnership with sponsors to provide scientific expertise, full-service assay development, and validation, followed by high- quality sample analysis to drive successful clinical trials forward.
 

Decades of experience in central and bioanalytical lab settings enables us to support our sponsors with the highest-quality robust flow cytometry assays. Our experience includes the majority of assay types that are required in clinical trials, such as Immunophenotyping  (from TBNK through complex deep-phenotyping), Target Occupancy (Receptor Occupancy, ADCC), and Functional assays (ex vivo stimulation assays, phosphoflow).

 

Full service assay development, validation, and clinical sample analysis

Early interaction with sponsors is vitally important to gain a thorough understanding of the requirements and the context of us (CoU.) We perform assay transfers as well as full assay development, which may include feasibility testing, screening for optimal reagents, and antibody clones. Assays are validated according to current guidelines, and suited for the clinical setting and CoU.

 

Global flow cytometry network

Our innovative and interconnected global flow cytometry network provides a central data repository and facilitates consistent result interpretation, as well as transfer of assays in support of global trials.

Bringing benefits to your trial

Client

Partnership

Our mission is to cultivate a partnership with sponsors to provide scientific expertise, full-service assay development and validation, followed by high quality sample analysis to drive successful clinical trials forward.

Content_Development

Robust assay development, validation, and tailored solutions

ICON has decades of experience implementing assay in various clinical settings from early phase single site to fully global multi-site. We develop robust assays that meet industry standards and are validated according to relevant whitepapers and CLSI chapter H62.

Leadership

Expert guidance

Our global team of flow cytometry scientists meets frequently to share knowledge, support lab-to-lab assay transfers, and global harmonization. Our scientists support sponsors from the start of a new project, building fit-for-purpose assays that meet expectations of the sponsor.

Quality

Quality Control and data integrity

We work with globally harmonised processes and instrumentation. Data is released into ICONs LIMS system after two levels of data analysis review with FCS Express 21 CFR p11 compliant software.

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