improved methods for increasing antibody productivity in mammalian cell culture and minimizing aggregation during downstream processes, formulation processes, and stable antibody formulations obtained from them

摘要

The present invention relates to an efficient antibody formulation and production platform that provides: i) cell culture process with improved feeding strategy resulting in high antibody titration between 2 g / l and 5 g / l; ii) improved purification process showing optimum percent recovery, high purity monomer content, minimal particulate aggregation / formation, minimum impurity levels; and iii) high concentration stable liquid formulation with optimum osmolality and low viscosity at different temperatures and without aggregation. Preferred antibodies include dengue virus epitope-specific monoclonal antibody igg1 in protein domain iii and rabies virus surface glycoprotein g-specific monoclonal antibody igg1.