	US 12,139,533 B2
	Liquid formulations of anti-CD200 antibodies
Dino Miano, Rocky Hill, CT (US); and Bruce Mason, Madison, CT (US)
Assigned to Alexion Pharmaceuticals, Inc., Boston, MA (US)
Appl. No. 16/954,868
Filed by Alexion Pharmaceuticals, Inc., Boston, MA (US)
PCT Filed Dec. 18, 2018, PCT No. PCT/US2018/066174 § 371(c)(1), (2) Date Jun. 17, 2020, PCT Pub. No. WO2019/126133, PCT Pub. Date Jun. 27, 2019.
Claims priority of provisional application 62/608,322, filed on Dec. 20, 2017.
Prior Publication US 2021/0087267 A1, Mar. 25, 2021
Int. Cl. A61K 39/395 (2006.01); C07K 16/28 (2006.01); A61K 39/00 (2006.01)

CPC C07K 16/2803 (2013.01) [A61K 2039/505 (2013.01); C07K 2317/565 (2013.01); C07K 2317/94 (2013.01)]

24 Claims

1. A liquid pharmaceutical formulation comprising:

(a) an anti-CD200 antibody or antigen binding fragment thereof at a concentration of between about 5 to 10 mg/mL, wherein the anti-CD200 antibody or antigen binding fragment comprises a light chain variable region comprising the sequence set forth in SEQ ID NO:11 and a heavy chain variable region comprising the sequence set forth in SEQ ID NO:10;

(b) about 1 to 3% mannitol;

(d) about 50 mM citrate buffer at a pH of about 5.0 to about 6, and

(e) about 75 to 150 mM NaCl;

wherein the formulation has an osmolality of less than 525 mOsm/kg and is stable at 2-8° C. for a period of at least 9 months.