GLYNN, JUDY KAY,CHEN, BRIAN XIN,LACASSE, DANIEL PATRICK
申请号:
CA2999118
公开号:
CA2999118A1
申请日:
2016.09.08
申请国别(地区):
CA
年份:
2017
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.