For each program, the team of MI-mAbs defines with the applicant a validation plan depending on the degree of progress of the project. Designed by scientists with a strong experience in validation of therapeutic antibodies in human and animals, this plan for an average of two years includes :
The generation of (human and mouse) antibodies of the isotype or the form desired (conjugated antibody).
Immunohistochemistry and bioinformatics studies to clarify the expression profile of the target.
Construction of specific animal models (genetically modified mice).
In vitro and in vivo antibody candidate evaluation tests in the animal (following pharmacokinetics, toxicity profile, immuno-monitoring and efficacy profile)
Finally, the choice of biological samples and tests that validate in humans the therapeutic window previously identified in animals.
At the end of this joint study, a work plan is analyzed for its cost and temporally defined (Gantt chart). Quarterly meetings allow us to follow the progress of the project.
The figure below retraces the main steps in the validation of a target-antibody pair: