Ramesh S. Kashi,Shona P. Patel,Sarita Mittal,Ashwin Basarkar,Shuai Shi
申请号:
US14443557
公开号:
US09649383B2
申请日:
2013.11.15
申请国别(地区):
US
年份:
2017
代理人:
摘要:
The invention provides stable liquid formulations for a recombinant biopharmaceutical protein comprising a soluble form of the human p75 TNF receptor fused to an Fe domain of a human immunoglobulin protein (TNFR:Fc). Typically, biopharmaceutical proteins such as monoclonal antibodies (mAbs) and immunoglobulin fusion proteins (e.g., immunoadhesion proteins) are produced by recombinant DNA technology in mammalian cell expression systems. In order to guarantee the reproducible clinical performance of a biopharmaceutical product, manufacturers have to deliver a product of consistent and reproducible quality.