Patent ID: 9085618
Filing Date: 2015-07-21
Classification: A61K,C07K

Abstract:
1. A low acidic species composition comprising adalimumab, wherein the composition comprises less than 10% total acidic species of adalimumab and wherein less than 75% of the lysine variant species of the composition have zero C-terminal lysines (Lys 0), and wherein the acidic species of adalimumab are quantified based on the relative area percent of peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5) and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm.