Title:
METHOD FOR PURIFYING GLP-1 ANALOG
Document Type and Number:
WIPO Patent Application WO/2021/129308
Kind Code:
A1
Abstract:
Disclosed is a method for purifying a GLP-1 analog, the method comprising the following steps: 1) purifying a GLP-1 analog by means of anion exchange; 2) purifying the purified substance obtained in 1) by means of reversed-phase chromatography. In the first step of purification, anion exchange purification technology that is more environmentally friendly, has lower solvent cost, and the capacity of which is larger is used, which achieves the enrichment of a target substance, and is complementary to reversed-phase chromatography technology, removing the amino acid deletion impurities that are difficult to remove during reversed-phase purification, and also reducing the cost and environmental protection pressure; in the second step of purification, high-resolution reversed-phase purification technology is used to remove isomer impurities, side reaction impurities, etc. that cannot be removed by means of anion exchange purification, and finally, a GLP-1 analog with a purity of ≥ 99.0% and a single impurity of ≤ 0.15% is obtained.
Inventors:
HUANG JIACHENG (CN)
YIN CHUANLONG (CN)
TAO ANJIN (CN)
YU PINXIANG (CN)
YIN CHUANLONG (CN)
TAO ANJIN (CN)
YU PINXIANG (CN)
Application Number:
PCT/CN2020/132230
Publication Date:
July 01, 2021
Filing Date:
November 27, 2020
Export Citation:
Assignee:
HYBIO PHARMACEUTICAL WUHAN CO LTD (CN)
HYBIO PHARMACEUTICAL CO LTD (CN)
HYBIO PHARMACEUTICAL CO LTD (CN)
International Classes:
C07K14/605; C07K1/20
Domestic Patent References:
| WO2000055203A1 | 2000-09-21 | |||
| WO2005059095A2 | 2005-06-30 |
Foreign References:
| CN105176886A | 2015-12-23 | |||
| CN109354622A | 2019-02-19 | |||
| EP3517543A1 | 2019-07-31 |
Other References:
ZHANG ZHI-ZHEN, LIU ZHI-HUI, MAO JI-FANG: "Purification and Activity Analysis of Recombinant Human Glucagon -like Peptide -1 Mutant", CHINESE JOURNAL OF BIOCHEMISTRY AND MOLECULAR BIOLOGY, ZHONGGUO SHENGWU HUAXUE YU FENZI SHENGWU XUEHUI, BEIJING, CN, vol. 21, no. 4, 1 August 2005 (2005-08-01), CN, pages 510 - 515, XP055823377, ISSN: 1007-7626, DOI: 10.13865/j.cnki.cjbmb.2005.04.014
WANG XUENA: "Study on Expression in E.Coli, Preparation and Activity Analysis of Lilagultide", CHINESE MASTER’S THESES FULL-TEXT DATABASE, MEDICINE & HEALTH SCIENCES, 1 May 2014 (2014-05-01), XP055823378
WANG XUENA: "Study on Expression in E.Coli, Preparation and Activity Analysis of Lilagultide", CHINESE MASTER’S THESES FULL-TEXT DATABASE, MEDICINE & HEALTH SCIENCES, 1 May 2014 (2014-05-01), XP055823378
Attorney, Agent or Firm:
BEIJING CHENGHUI LAW FIRM (CN)
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