The characterisation of biomarkers by flow cytometry is an attractive approach for Quality Control applications of cell products. Unfortunately, the design of a customised panel remains challenging, especially for stem cell products. The aim of this study was to generate customised labelled antibodies with three classes of fluorochromes allowing multi-parameters analyses by flow cytometry. The “in-house” labelled antibodies were compared to their commercial counterparts and their stability was evaluated. These antibodies were used in the context of a method validation to evaluate their intrinsic performances.
Our protocol allows the labelling of antibodies with fluorochromes that match the customer’s and regulator’s needs. The “16/3” validation design used in this study allows the generation of a complete dataset suitable for meaningful statistical analyses.