Patent ID: 9150645
Filing Date: 2015-10-06
Classification: A61K,C07K,C12P

Abstract:
1. A method for producing a composition comprising adalimumab, the method comprising culturing a mammalian cell producing adalimumab in cell culture media comprising 2 g/L to 11 g/L of each of one or more basic amino acids selected from the group consisting of arginine, lysine, ornithine and histidine, and combinations thereof, to produce a composition comprising adalimumab, wherein the composition comprises less than 20% total acidic species of adalimumab, wherein the acidic species of adalimumab do not include process-related impurities selected from the group consisting of host cells and lysed host cells and wherein the acidic species of adalimumab correspond to the peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab, and wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10 mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10 mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5), and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm.