ANTAGONIST ANTI-CD40 ANTIBODY PHARMACEUTICAL COMPOSITION

摘要

PROBLEM TO BE SOLVED: To provide a stable liquid pharmaceutical compositions comprising an antagonist anti-CD40 antibody as a therapeutically or prophylactically active component and methods useful in their preparation.SOLUTION: The compositions comprise the antagonist anti-CD40 antibody, a buffering agent to maintain the pH of the composition between about pH 5.0 and about pH 7.0, and an amount of arginine-HCl sufficient to render the liquid composition near isotonic. In one embodiment, the buffering agent is a citrate/citric acid buffer, the antagonist anti-CD40 antibody is the CHIR-12.12 or CHIR-5.9 antagonist anti-CD40 antibody or antigen-binding fragment thereof, the composition comprises arginine-HCl as the isotonizing agent, and the composition further comprises a nonionic surfactant and/or L-methionine as further stabilizing agents. The stable liquid antagonist anti-CD40 antibody-containing pharmaceutical compositions find use in methods for treating proliferative diseases and diseases having an autoimmune and/or inflammatory component.