Improved methods, formulation methods, and resulting stable antibody formulations for improving antibody productivity and minimizing aggregation in downstream mammalian cell culture

摘要

The present invention describes an efficient platform for antibody production and formulation that provides: i) a cell culture method with an improved feeding strategy that results in high antibody titers from 2 gm / l to 5 gm / l; ii) improved purification methods exhibiting optimal recovery, high purity monomer content, minimal aggregation / particle formation, minimum impurity levels; and iii) having optimal osmolality and low viscosity over different temperature ranges, and Not a high concentration stable liquid formulation. Preferred antibodies include IgG1 monoclonal antibodies specific for dengue virus epitopes in domain III of the E protein, and IgG1 monoclonal antibodies specific for rabies virus surface G glycoprotein. [Selection diagram] Fig. 1