公开(公告)号：US20230134160A1

公开(公告)日：2023-05-04

申请号：US15761777

申请日：2016-09-08

Applicant: PFIZER INC.

Inventor： Judy Kay GLYNN ,  Brian Xin CHEN ,  Daniel Patrick LACASSE

IPC: A61K39/395 ,  C07K1/34 ,  A61K47/22 ,  A61K47/26 ,  A61K47/18 ,  C07K16/28

Abstract: 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 inven tion, 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.