Cellular Biomarkers
(Flow Cytometry)

A Biomarker can roughly be described as an indicator of biological function or activity or a defined characteristic that is measured as an indicator of normal biological responses, pathogenic processes or a biological response to an exposure. Biomarkers might be therefore be soluble proteins, cell populations, molecular biomarkers (DNA or RNA) or a biological process (e.g., blood pressure).

At Agilex, we use a context-of-use (COU) framework for Biomarker assays. The COU is a concise description of the biomarker’s specified use in the study. Each qualification or validation effort for a biomarker should identify a single COU, to understand the purpose of the biomarker to guide assay selection at the outset and to provide an understanding of the expected data (expected fold change of dosed individuals compared with pre-dose/basal or expected pharmacodynamic changes elicited by the therapeutic).

Quality Management System

Agilex Biolab’s electronic quality management system (eQMS) provides a standardized approach to; control our documented procedures, identify and reduce risks, prevent recurrence of errors and ensure quality.

Our chosen eQMS platform is trusted by life sciences companies worldwide and provides us with a fully validated set of quality and compliance processes, and complies with standards such as ISO/IEC 17025, 21 CFR Part 11, and ISO/IEC 27001.

Quality Planning & Review

Annually, we evaluate the performance and effectiveness of our quality processes to; determine and set key quality indicators, and develop actions for continued quality process improvement. The key quality indicators and their set criteria, and the process improvement actions are reviewed, measured, reported and communicated at the operational management level quarterly to ensure our ongoing commitment to quality is being achieved.