Patent ID: 11857625
Assignee: UCB BIOPHARMA SRL
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  C | IPC A  C

Claim 5:
6. A method for preparing a pharmaceutical composition, wherein the method comprises:
a) preparing a low concentration of formulation by combining from about 40 mg/ml to about 50 mg/ml of an antibody, or an antigen-binding fragment thereof, comprising a heavy chain variable region comprising the SEQ ID NO:1 and a light chain variable region comprising the SEQ ID NO:2 with a buffer comprising glycine and acetate at pH of from about 4.6 to about 5.5;
b) preparing a high concentration formulation by concentrating the antibody or antigen-binding fragment thereof the low concentration formulation obtained in a) to a concentration of about 160 mg/ml to about 180 mg/ml;
c) adding to the high concentration formulation obtained in b) about 0.02% to about 0.06% polysorbate 80; and
d) before step c) adjusting the concentration of the antibody or antigen-binding fragment thereof so the buffer comprising about 40 to about 90 mM of acetate and about 160 mM to about 300 mM of glycine.