Title:
PREPARATION METHODS FOR A HIGHLY CONCENTRATED PD1 ANTIBODY SOLUTION BY ULTRAFILTRATION/DIAFILTRATION (UF/DF)
Document Type and Number:
WIPO Patent Application WO/2024/012364
Kind Code:
A1
Abstract:
Provided is a preparation method of highly concentrated antibody solution that binds to human programmed death receptor 1 (PD1). This process is able to manufacture the high concentrated antibody solution by an ultrafiltration/diafiltration (UF/DF) unit operation described herein. The UF/DF preparation method comprises mainly a first ultrafiltration concentration step, a buffer solution diafiltration step, and a second ultrafiltration concentration step. The process has a broad operation parameter range and maintains antibody stability and integrity when compared to low concentration antibody preparation.
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Inventors:
JI YU (CN)
LI XUENING (CN)
DING JIANKUN (CN)
QIU BO (CN)
LI XUENING (CN)
DING JIANKUN (CN)
QIU BO (CN)
Application Number:
PCT/CN2023/106294
Publication Date:
January 18, 2024
Filing Date:
July 07, 2023
Export Citation:
Assignee:
BEIGENE SWITZERLAND GMBH (CH)
JI YU (CN)
JI YU (CN)
International Classes:
C07K16/28
Domestic Patent References:
| WO2021167275A1 | 2021-08-26 |
Foreign References:
| CN105531288A | 2016-04-27 | |||
| CN101056885A | 2007-10-17 | |||
| CN101754977A | 2010-06-23 | |||
| CN101874040A | 2010-10-27 | |||
| CN104193822A | 2014-12-10 | |||
| CN104231075A | 2014-12-24 | |||
| CN105085610A | 2015-11-25 | |||
| CN114014929A | 2022-02-08 |
Attorney, Agent or Firm:
WU, FENG & ZHANG (CN)
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