ICON’s flow cytometry expertise powers monoclonal antibody drug development

A pharmaceutical company with a strong background in small molecule development faced a significant challenge after acquiring a monoclonal antibody drug candidate. Unlike small molecules, monoclonal antibody-based therapies require highly specialised cellular assays to demonstrate proof-of-concept, mechanism-of-action, and receptor binding. Off-the-shelf assays were insufficient for these needs, and a robust, cell-based biomarker assay was essential to conduct this clinical trial. To address this, the company turned to ICON Laboratories for expert support in developing and implementing a customised cellular assay.

ICON responded by designing a comprehensive solution that included the development, optimisation, validation, and implementation of a complex Receptor Occupancy Assay tailored to the drug candidate. To ensure the assay was both scientifically rigorous and clinically relevant, ICON incorporated customised validation samples—specifically a transfected cell line, in vitro stimulated peripheral blood mononuclear cells (PBMCs), and both normal and disease-state whole blood samples. The assay was validated using a “fit-for-purpose” approach, and ICON further enhanced its reliability by constructing and validating a custom data analysis template with standardised gating. Additionally, a standard operating procedure (SOP) was developed for consistent sample processing, and multi-level reviews of flow cytometry data were performed to maintain accuracy and quality throughout the study.

This was a successful collaboration that delivered critical data to the sponsor throughout the multi-year clinical trial. ICON’s Flow Cytometry Operational Laboratory ran the Receptor Occupancy Assay across multiple cohorts, while the R&D team designed a custom quality control process to monitor reagent stability over time. Continuous communication and data review for multiple cohorts ensured the delivery of high-quality datasets.

Ultimately, the sponsor benefited from ICON’s deep expertise in cell biology, immunology, and flow cytometry, which enabled the development and execution of a highly informative Receptor Occupancy Assay. This partnership not only met the sponsor’s scientific and operational needs but also reinforced ICON’s value as a trusted collaborator in complex clinical research.