Method of investigating the response to a treatment using a monoclonal antibody

In vitro evaluation of effector functions of cells expressing FcyRIIIa in monoclonal antibody to be tested, comprises contacting the cells with the monoclonal antibody, immobilized on support, in an agent inhibiting cytokines secretion by the cells; performing the same experiment using monoclonal antibody directed against the receptor FcyRIIIa, as a positive control of activation of the cells; observing the response of the cells by measuring the presence e.g. of marker cluster of differentiation (CD107), after an incubation time of at least one hour. Method for in vitro evaluating the effector functions of cells expressing FcyRIIIa in response to a monoclonal antibody to be tested, comprises contacting the cells expressing the FcRIIIa with monoclonal antibody, immobilized on a support, in the presence of an agent inhibiting the secretion of cytokines by the cells; performing the same experiment using a monoclonal antibody directed against the receptor FcyRIIIa, in place of the monoclonal antibody to be tested, as a positive control of the activation of cells expressing the FcyRIIIa; observing the response of the cells expressing FcyRIIIa by measuring the presence of the marker CD107 at the cell surface, as well as the presence of intracellular gamma interferon (IFNgamma ) and/or intracellular tumor necrosis factor-alpha (TNFalpha ), after an incubation time of at least one hour. An independent claim is included for a kit used for the implementation of the method comprising elements containing a monoclonal antibody anti-CD16 coupled to the marker, a monoclonal antibody anti-IFNgamma coupled to the marker and/or monoclonal antibody anti-TNFalpha coupled to the marker, and a plate containing at least a trough filled with monoclonal antibodies against FcyRIIIa receptor. L'invention se rapporte aux étapes de mise au point ou de contrôle qualité des anticorps monoclonaux recombinants (AcMor) utilisés comme médicaments, ainsi qu'à la sélection des patients susceptibles de répondre efficacement à un traitement par un anticorps monoclonal donné. Plus précisément, l'invention concerne une méthode pour évaluer in vitro les fonctions effectrices de cellules NK en réponse à un anticorps monoclonal à tester, comportant au moins les étapes suivantes : (i) les cellules NK sont mises en contact avec ledit anticorps monoclonal, immobilisé sur un support, en présence d'un agent inhibant la sécrétion des cytokines par lesdites cellules ; (ii) à titre de contrôle positif de l'