ГЛИНН Джуди Кей (US),ЧЕН Брайан Синь (US),ЛАКАССЕ Даниэль Патрик (US)
申请号：
RU2018110145
公开号：
RU2018110145A
申请日:
2016.09.08
申请国别(地区):
RU
年份:
2019
代理人:
摘要：
The invention relates to a method of preparing a protein formulation including a therapeutic protein, the method comprising the steps of: providing a solution comprising said protein； concentrating the protein in the solution by a first ultra-filtration step； diafiltering the solution with a diafiltration buffer including at least one first excipient, whereby a retentate is obtained comprising the protein and the first excipient； further concentrating the protein in the retentate by a second ultra-filtration step； and adding at least one final excipient, whereby the protein formulation with a desired protein concentration is obtained. According to the invention, the method further comprises, before the second ultra- filtration step, adding a second excipient to the retentate obtained from the diafiltration step. The invention is also directed to antibody formulations produced by the foregoing method.
