US 12,065,482 B2
Stable liquid pharmaceutical formulation of anti-influenza virus antibody
Joon Won Lee, Incheon (KR); Won Yong Han, Incheon (KR); Su Jung Kim, Incheon (KR); Jun Seok Oh, Incheon (KR); So Young Kim, Incheon (KR); Kwang Woo Kim, Incheon (KR); and Yeon Kyeong Shin, Incheon (KR)
Assigned to Celltrion Inc., Incheon (KR)
Appl. No. 16/324,364
Filed by Celltrion Inc., Incheon (KR)
PCT Filed Aug. 9, 2017, PCT No. PCT/KR2017/008605
§ 371(c)(1), (2) Date Feb. 8, 2019,
PCT Pub. No. WO2018/030777, PCT Pub. Date Feb. 15, 2018.
Claims priority of application No. 10-2016-0101719 (KR), filed on Aug. 10, 2016.
Prior Publication US 2021/0347861 A1, Nov. 11, 2021
Int. Cl. A61K 39/395 (2006.01); A61K 9/00 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61P 31/16 (2006.01); C07K 16/10 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/1018 (2013.01) [A61K 9/0019 (2013.01); A61K 39/39591 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61P 31/16 (2018.01); A61K 2039/507 (2013.01); A61K 2039/545 (2013.01); C07K 2317/56 (2013.01); C07K 2317/565 (2013.01); C07K 2317/94 (2013.01)] 9 Claims
 
1. A stable liquid pharmaceutical formulation comprising:
25 to 50 mg/mL of a mixture of two or more different anti-influenza virus (A) antibodies;
(B) 0.02 to 0.1% (w/v) of a surfactant, wherein the surfactant (B) comprises polysorbate 80;
(C) 1.0 to 5% (w/v) of a sugar or its derivative, wherein the sugar is sorbitol; and
(D) 5 to 15 mM of histidine;
wherein the pharmaceutical formulation has a pH of 6, and
wherein the mixture of two or more different anti-influenza virus antibodies (A) comprises:
i) an antibody comprising a light-chain variable region comprising a CDR1 region of SEQ ID NO: 1, a CDR2 region of SEQ ID NO: 2 and a CDR3 region of SEQ ID NO: 3, and a heavy-chain variable region comprising a CDR1 region of SEQ ID NO: 4, a CDR2 region of SEQ ID NO: 5, and a CDR3 region of SEQ ID NO: 6; and
ii) an antibody comprising a light-chain variable region comprising a CDR1 region of SEQ ID NO: 7, a CDR2 region of SEQ ID NO: 8 and a CDR3 region of SEQ ID NO: 9, and a heavy-chain variable region comprising a CDR1 region of SEQ ID NO: 10, a CDR2 region of SEQ ID NO: 11, and a CDR3 region of SEQ ID NO: 12.