US 12,012,448 B2
High concentration anti-C5 antibody formulations
Stephan Ortiz, Guilford, CT (US); Jillian Gentile, Southington, CT (US); Leena Philominathan, Cheshire, CT (US); Eric Routhier, Killingworth, CT (US); and Bruce Mason, Madison, CT (US)
Assigned to Alexion Pharmaceuticals, Inc., Boston, MA (US)
Filed by Alexion Pharmaceuticals, Inc., Boston, MA (US)
Filed on Dec. 21, 2022, as Appl. No. 18/086,031.
Application 17/738,131 is a division of application No. 16/633,930, granted, now 11,365,241, issued on Jun. 21, 2022, previously published as PCT/US2018/044071, filed on Jul. 27, 2018.
Application 18/086,031 is a continuation of application No. 17/738,131, filed on May 6, 2022.
Claims priority of provisional application 62/537,741, filed on Jul. 27, 2017.
Prior Publication US 2023/0257456 A1, Aug. 17, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/395 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); C07K 16/18 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/18 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61K 2039/505 (2013.01); C07K 2317/526 (2013.01); C07K 2317/565 (2013.01)] 13 Claims
 
1. A stable aqueous solution comprising:
(a) an anti-C5 antibody at a concentration of about 70 mg/mL, wherein the anti-C5 antibody comprises a heavy chain CDR1 comprising the amino acid sequence depicted in SEQ ID NO:19, a heavy chain CDR2 comprising the amino acid sequence depicted in SEQ ID NO:18, a heavy chain CDR3 comprising the amino acid sequence depicted in SEQ ID NO:3, a light chain CDR1 comprising the amino acid sequence depicted in SEQ ID NO:4, a light chain CDR2 comprising the amino acid sequence depicted in SEQ ID NO:5, and a light chain CDR3 comprising the amino acid sequence depicted in SEQ ID NO:6;
(b) about 50 mM Phosphate Buffer;
(c) about 5% sucrose; and
(d) about 25 mM Arginine.