MODEL FOR PREDICTION OF TOLERABILITY ISSUES IN CONNECTION WITH INTRAVENOUS ADMINISTRATION OF THERAPEUTIC ANTIBODIES

摘要

Described herein is a model for predicting if a therapeutic antibody binding to a human target will be associated with a tolerability issue in connection with intravenous administration and/or for predicting if pre-treatment, altered administration route or modification of the antibody can prevent a tolerability issue associated with intravenous administration to a human of the therapeutic antibody. The model comprises administering the antibody intravenously or intraperitoneally to mice and observing the mice immediately after the administration for any transient display of the macroscopic symptoms isolation and decreased activity. The model may also comprise administration of a pre-treatment in combination with administration of the antibody, administration of the therapeutic antibody by a route of administration other than intravenous or intraperitoneal administration or administration of a modified format of the antibody to mice and observing the mice immediately after such administration for any transient display of the macroscopic symptoms isolation and decreased activity and comparing this with the transient display of the macroscopic symptoms isolation and decreased activity after the intravenous or intraperitoneal administration of the unmodified antibody without pre-treatment.