Human antibodies that bind human TNF-alpha and methods of preparing the same

摘要

Methylglyoxal (MGO)-modified recombinant TNF-alpha antibodies (e.g., Adalimumab) are identified. MGO modification decreases binding between Adalimumab and TNF-alpha. Methods are disclosed for reducing the presence of MGO-modified antibodies in the production of Adalimumab TNF-alpha antibodies.

主权项

1. A method for purifying a composition comprising adalimumab, the method comprising:
(a) contacting a cation exchange adsorbent with a composition comprising adalimumab and adalimumab comprising one or more methylglyoxal (MGO)-modified arginine amino acids at position 30 (R30) of SEQ ID NO. 1, position 93 (R93) of SEQ ID NO. 1, position 108 (R108) of SEQ ID NO. 1, position 16 (R16) of SEQ ID NO. 2, position 259 (R259) of SEQ ID NO. 2, position 359 (R359) of SEQ ID NO. 2, or position 420 (R420) of SEQ ID NO. 2; (b) removing adalimumab comprising one or more methylglyoxal (MGO)-modified arginine amino acids from the cation exchange adsorbent; and (c) subsequently eluting the adalimumab from the cation exchange adsorbent using an elution buffer.