GOKARN, YATIN,WURTH, CHRISTINE,ZARRAGA, ISIDRO E.,PATAPOFF, THOMAS,ZARZAR, JONATHAN
申请号:
MX2015011425
公开号:
MX2015011425A
申请日:
2014.03.13
申请国别(地区):
MX
年份:
2016
代理人:
摘要:
The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations. In the past years, advances in biotechnology have made it possible to produce a variety of proteins for pharmaceutical applications using recombinant DNA techniques.La invención proporciona formulaciones farmacéuticas acuosas estables que comprenden un anticuerpo terapéutico, trealosa, un amortiguador, y tensoactivo opcional, y que tienen un pH en el intervalo de aproximadamente 5.5 hasta aproximadamente 7.0. La invención también proporciona métodos para preparar esas formulaciones y métodos de uso de esas formulaciones.