Title:
治療用タンパク質製剤を調製する方法、およびそのような方法により生成される抗体製剤
Document Type and Number:
Japanese Patent JP6925111
Kind Code:
B2
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.
Inventors:
Judy Kay Grin
Brian Shin Chen
Daniel Patrick Lacasse
Brian Shin Chen
Daniel Patrick Lacasse
Application Number:
JP2016181594A
Publication Date:
August 25, 2021
Filing Date:
September 16, 2016
Export Citation:
Assignee:
Pfizer Inc.
International Classes:
A61K39/395; A61K9/08; A61K38/00; A61K47/14; A61K47/18; A61K47/22; A61K47/26
Domestic Patent References:
| JP2013522170A |
Foreign References:
| US20110256149 | ||||
| US20140120086 | ||||
| US20140056888 |
Other References:
Pharm Res.,2014年,31,p.3161-3178
Attorney, Agent or Firm:
Noh four
Junko Miyazawa
Maki Sato
Tatsuta Miyuki
Junko Miyazawa
Maki Sato
Tatsuta Miyuki