US 11,053,317 B2
Pharmaceutical preparation stably comprising CD147 monoclonal antibody
Hao Tang, Changzhou (CN); Qiang Feng, Changzhou (CN); and Xiaochun Chen, Changzhou (CN)
Assigned to JIANGSU PACIFIC MEINUOKE BIO-PHARMACEUTICAL CO., LTD., Jiangsu (CN)
Appl. No. 16/461,800
Filed by JIANGSU PACIFIC MEINUOKE BIO-PHARMACEUTICAL CO., LTD., Jiangsu (CN)
PCT Filed Dec. 27, 2017, PCT No. PCT/CN2017/118893
§ 371(c)(1), (2) Date May 17, 2019,
PCT Pub. No. WO2018/121578, PCT Pub. Date Jul. 5, 2018.
Claims priority of application No. 201611271126.8 (CN), filed on Dec. 30, 2016.
Prior Publication US 2019/0359709 A1, Nov. 28, 2019
Int. Cl. C07K 16/28 (2006.01); A61K 9/08 (2006.01); A61K 47/12 (2006.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61K 9/00 (2006.01)
CPC C07K 16/2803 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/12 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); C07K 2317/94 (2013.01)] 3 Claims
 
1. A pharmaceutical formulation, comprising a monoclonal anti-CD147 antibody, a buffer, a protein protective agent and a surfactant, wherein the buffer is succinate buffer, the protein protective agent is trehalose, and the surfactant is polysorbate 20,
wherein the monoclonal anti-CD147 antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17 or SEQ ID NO: 18 and a light chain comprising the amino acid sequence of SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21 or SEQ ID NO: 22, wherein the concentration of the monoclonal anti-CD147 antibody in the pharmaceutical formulation is 20.0 mg/ml,
wherein the concentration of the succinate buffer is 25 mmol/L, the concentration of the trehalose in the pharmaceutical formulation is 75 mg/ml, the concentration of the polysorbate 20 in the pharmaceutical formulation is 0.40 mg/ml,
wherein the pharmaceutical formulation has a pH of 5.0-6.0.