Development of an immunogenicity method for detecting anti-EPO antibodies in human serum using Gyrolab platform

During biotherapy, the formation of anti-drug antibodies (ADAs) can pose significant risks to patients, such as neutralising the therapeutic effects of the drug or provoking undesirable immunogenicity effects. Therefore, accurate and efficient ADA detection is essential to ensure the safety and efficacy of therapeutic treatments. Gyrolab technology provides a state-of-the-art solution for ADA detection, offering high sensitivity, speed, and automation.

In this study, we used the Gyrolab platform to develop a method for detecting ADAs against erythropoietin (EPO). This method shows significant potential for the rapid detection of ADAs in patients undergoing recombinant EPO therapy for anemia.

The qualification of an ADA detection assay using the Gyrolab xPlore was successfully applying using the EPO model. The Gyrolab method was found to be precise within a range of 50 to 1000 ng/mL. The specificity of the assay was also demonstrated using an irrelevant antibody (Rituximab). As shown in the screening cut point results, the response level at and above which a sample is considered reactive for the presence of antibodies is equal to 0.02499 (response unit).

Based on these data, the method sensitivity can be set at 50 ng/mL even in the presence of 0.1 μg/mL of free EPO. In the presence of higher concentrations of free EPO (1 μg/mL), the method is still able to detect anti-EPO at 100 ng/mL, as recommended by FDA guidance (Immunogenicity Testing of Therapeutic Protein Products ꟷ Developing and Validating Assays for Anti-Drug Antibody Detection - Guidance for Industry). Consequently, due to its speed, low sample consumption, and automation, Gyrolab is the equipment of choice for ADA determination in a GxP environment.