“…In 2004 and 2005, the quantity of C-terminal lysine residues ranged from 86% to 88% and from 87% to 89%, respectively. 5 Similar to adalimumab, batches of innovator etanercept vary within and between each process revision from 1998 to 2015. The following mean and median ranges compare standard (Process A) to process revisions (Process B, C, D) based on several physiochemical characteristics: quantity of aggregated and misfolded species (18-20%, 15%, 12-14%, 15-16%), purity/impurity (30-34 ppm, 10-12 ppm, 4-5 ppm, 5-6 ppm), binding to TNF [107-108 binding units (BU), 111-113 BU, 115-117 BU, 111-113 BU] and potency to inhibit TNF-based apoptosis (1.5-1.6 U/mg, 1.7-1.8 U/mg, 1.7-1.8 U/mg, 1.7-1.75 U/mg) across all batches, respectively.…”