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Venez découvrir nos solutions pour caractériser vos anticorps monoclonaux à travers une présentation de nos tests de cytotoxicité (ADCC, CDC, apoptose) lors d’un webinaire présenté par Alexis ROSSIGNOL, chef de projet PhD et spécialiste des “bio assay” à Clean Cells.

Description :

In the field of therapeutic antibodies, standardized and biologically relevant potency assays are required by Regulators for product characterization and quality control. Among the variety of antibody biological activities, the induction of target cell death by either apoptosis, ADCC (antibody-dependent cellular cytotoxicity), CDC (complement-dependent cytotoxicity) or chimeric antigen receptor (CAR)-T cell therapy is a key mechanism of action, and thus have to be characterized by appropriate potency assays.
For now, the most specific, sensitive and versatile method for evaluating target cell death is the radioactive 51Cr release assay. However, radioactive methods are very difficult to implement in an industrial context and alternative methods (such as calcein or enzymes release-based assays) generally suffer from poor performances, resulting in difficulties in assay validation. Furthermore, available surrogate assays, such as FcγR affinity or effector cell activation assays, do not comply with the Regulatory requirement of biological relevance, i.e. the final lysis of target cells.
Starting from these observations, we developed a non radioactive luminescent method, specific of target cell cytolysis. The presentation will focus on the description of this new method for ADCC and CDC measurement, using 3 different antibody models and following an ICH-Q2(R1)- and USP1033-based approach.
Altogether, the results show that this method is a perfect candidate for developing regulatory-compliant potency assays for characterizing cytotoxic biotherapeutics, including antibodies (ADCC, CDC) or cell-based therapies (CAR-T). The high level of sensitivity and the ease of use are also a key advantages at early stages of development.

Nous vous donnons rendez-vous Jeudi 1er Octobre à 16h00 pour ce webinaire. 
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