MODULATED LYSINE VARIANT SPECIES COMPOSITIONS AND METHODS FOR PRODUCING AND USING THE SAME

摘要

The instant invention relates to modulated lysine variant species compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such modulated lysine variant species compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNFα is detrimental, are also provided.

主权项

1. A method for treating a subject having a disorder in which TNFα activity is detrimental, the method comprising administering a therapeutically effective amount of a composition comprising a human anti-TNFα antibody, wherein less than 65% of the lysine variant species in said composition have zero C-terminal lysines (Lys 0),
wherein the lysine variant species include the main peak and peaks that elute at a relative residence time later than the main peak, as detected using weak cation-exchange chromatography, and wherein the human anti-TNFα antibody comprises a light chain variable region (LCVR) having a CDR1 domain comprising the amino acid sequence of SEQ ID NO:7, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3; and a heavy chain variable region (HCVR) having a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:6, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4; thereby treating the TNFα-associated disease or disorder.