Method for preparing antibody-containing formulation

• Main Authors: KOPF, ROBERT, SAITOH, SATOSHI, OLTRA, NURIA SANCHO, FUKUDA, MASAKAZU, TAKAHASHI, MASAYA, RAVURI, KISHORE, SOEDA, KOHEI, IMAI, HIROTAKA, CHEN, WEI, DUBOEUF, JEREMY
• Format: Patent
• Language: Chinese; English
• Published: 01.09.2023
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PERFORMING OPERATIONS; PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SEPARATION; TRANSPORTING

The present invention provides a pharmaceutical formulation that reduces formation of particles including an anti-IL-6 receptor antibody that inhibits binding with a receptor for interleukin 6 or an anti-blood coagulation factor IXa/X antibody (bispecific monoclonal antibody) used as a substitution for coagulation factor VIII. The provided pharmaceutical formulation includes an aqueous solution containing a polyoxyethylene polyoxypropylene glycol (poloxamer). The poloxamer is represented by formula I: HO(C2H4O)a(C3H6O)b(C2H4O)cH [in the formula, a and c each independently represent an integer selected from 75-85, b represents an integer selected from 22-33, and a, b, and c are each an average with respect to the whole of the poloxamer]. The poloxamer contains a poloxamer molecule including 34 or more of (C3H6O) within the molecule, at a proportion of 3%(w/w) or more with respect to the whole poloxamer.