ШАРМА Манодж К.,НАРАСИМХАН Чакраварти Начу,ГЕРГИЧ Кевин Джеймс,КАНГ Соонмо Питер
申请号：
RU2015123476
公开号：
RU2015123476A
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 comprising: a) said anti-PD-1 or antigen binding fragment thereof b) a histidine buffer c) polysorbate 80 and d) saharozu.2. Lyophilized composition according to Claim. 1, where the composition has a pH after reconstitution 5.0 to 6,0.3. Lyophilized composition according to Claim. 1, making it possible to recover the antibody or antigen binding fragment thereof at a concentration of about 25 mg / ml to 100 mg / ml.4. Lyophilized composition according to Claim. 1 wherein the polysorbate 80 is present in a weight ratio of about 0.02% (wt. / Vol.). 5. Lyophilized composition according to Claim. 1 wherein sucrose is present in a weight ratio of about 7% (wt. / Vol.). 6. The lyophilized pharmaceutical composition of anti-PD-1 or antigen binding fragment thereof obtainable 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 of polysorbate 80 and d) about 10 mM histidine buffer at pH 5,0-6,0.7. The lyophilized pharmaceutical composition according to claim. 6, where the anti-PD-1 or antigen binding fragment thereof present in aqueous solution in a concentration of about 25 mg / ml.8. The lyophilized pharmaceutical composition according to claim. 6, wherein the aqueous solution has a pH of about 5,5.9. The lyophilized pharmaceutical composition of anti-PD-1 or antigen binding fragment thereof comprising, after recovery: a) 25-100 mg / ml anti-human PD-1 or fragment egoantigensvyazyvayuschego b) about 70 mg / ml sucrose c) approximated1. Лиофилизированный состав антитела против PD-1 человека или его антигенсвязывающего фрагмента, содержащий:a) указанное антитело против PD-1 человека или его антигенсвязывающий фрагментb) гистидиновый буферc) полисорбат 80 иd) сахарозу.2. Лиофилизированный состав по п. 1, где состав после восстановления имеет pH от 5,0 до 6,0.3. Лиофилизированный состав по
