ШАРМА Манодж К. (US),НАРАСИМХАН Чакраварти Начу (US),ГЕРГИЧ Кевин Джеймс (US),КАНГ Соонмо Питер (US)
申请号：
RU2013148537/10
公开号：
RU2013148537A
申请日:
2012.03.29
申请国别(地区):
RU
年份:
2015
代理人:
摘要：
1. Lyophilized composition antibody against PD-1 or antigen binding fragment thereof, obtained by lyophilization of an aqueous solution containing: a) 25-100 mg / ml anti-PD-1 or antigen binding fragment thereof b) about 70 mg / mL sucrose c) about 0.2 mg / ml polysorbate 80 and d) about 10 mM histidine buffer at a pH of about 5.5-6.0, and wherein the antibody or antigen-binding fragment comprises: i) a light chain comprising three sequences of CDR SEQ ID NO: 15, 16 and 17 and ii) a heavy chain comprising three sequences of CDR SEQ ID NO: 18, 19 and 20.2. The lyophilized pharmaceutical composition according to claim 1, wherein the antibody against PD-1 or antigen binding fragment thereof present in aqueous solution at a concentration of about 25 mg / ml.3. The lyophilized pharmaceutical composition according to claim 1, wherein the aqueous solution has a pH of about 5,5.4. The lyophilized pharmaceutical composition according to claim 1, wherein the antibody comprises a light chain comprising amino acid residues 20-237 of SEQ ID NO: 36 and a heavy chain comprising amino acid residues 20-466 of SEQ ID NO: 31.5. The lyophilized pharmaceutical composition according to claim 1, wherein the antibody is h409A11.6. The liquid pharmaceutical composition of anti-PD-1 or antigen binding fragment comprising: a) 25-100 mg / ml anti-PD-1 or antigen binding fragment thereof b) about 70 mg / mL sucrose c) about 0.2 mg / ml of polysorbate 80 and d) about 10 mM histidine buffer at pH 5,0-6,0, wherein the antibody or antigen-binding fragment comprises: i) a light chain comprising three sequences of CDR SEQ ID NO: 15, 16 and 17 and ii) a heavy chain comprising three sequences of CDR SEQ ID NO: 18, 19 and 20.1. Лиофилизированный состав антитела против PD-1 человека или его антигенсвязывающего фрагмента, полученный лиофилизацией водного раствора, содержащего:a) 25-100 мг/мл антитела против PD-1 человека или его антигенсвязывающего фрагментаb) приблизительно 70 мг/мл сахарозыc) приблизите
