HIGH CONCENTRATION FORMULATIONS OF ANTI-C5 ANTIBODIES

摘要

The present disclosure relates to, inter alia, stable aqueous solutions comprising a high concentration of an antibody that binds to human complement component C5 and methods for preparing the solutions. The disclosure also provides methods for treating or preventing complement-associated disorders (for example, age-related macular degeneration or rheumatoid arthritis) using the solutions. Also featured are therapeutic kits containing one or more of the solutions and a means for administering the solutions to a patient in need such a treatment.

主权项

1. A method for treating a patient having a complement-associated disorder comprising administering to the patient a stable aqueous solution comprising:
(a) an anti-C5 antibody at a concentration of about 100 mg/mL to about 200 mg/mL, wherein the anti-C5 antibody comprises CDR1, CDR2, and CDR3 domains of a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:13 and CDR1, CDR2, and CDR3 domains of a light chain comprising the amino acid sequence set forth in SEQ ID NO:12, (b) about 20 mM histidine, (c) about 50 mM serine, (d) about 3% (w/v) sorbitol, and (e) about 1.5% (w/v) mannitol.