CN111601819A - 一种重组人胰岛素或其类似物的前体的制备方法 - Google Patents

一种重组人胰岛素或其类似物的前体的制备方法 Download PDF

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CN111601819A
CN111601819A CN201980008838.6A CN201980008838A CN111601819A CN 111601819 A CN111601819 A CN 111601819A CN 201980008838 A CN201980008838 A CN 201980008838A CN 111601819 A CN111601819 A CN 111601819A
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insulin
precursor
human recombinant
hollow fiber
liquor
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赵亮亮
韩广杰
牛宁宁
李娜
刘衍伟
王宏伟
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Jiangsu Hengrui Medicine Co Ltd
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
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    • C12P21/00Preparation of peptides or proteins
    • C12P21/06Preparation of peptides or proteins produced by the hydrolysis of a peptide bond, e.g. hydrolysate products
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
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    • BPERFORMING OPERATIONS; TRANSPORTING
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    • B01DSEPARATION
    • B01D63/00Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02Hollow fibre modules
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/20Partition-, reverse-phase or hydrophobic interaction chromatography
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    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/62Insulins
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    • C12P21/00Preparation of peptides or proteins
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01D2311/04Specific process operations in the feed stream; Feed pretreatment
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    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01DSEPARATION
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    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2315/00Details relating to the membrane module operation
    • B01D2315/10Cross-flow filtration

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Abstract

一种重组人胰岛素或其类似物的前体的制备方法,包括a.菌体发酵,将发酵液进行连续流离心,收集清液;b.将步骤a中的清液经过中空纤维膜过滤,收集滤液;c.将步骤b中的滤液通过层析柱进行纯化。该方法具有步骤精简、易放大生产、无有机溶剂、收率高等优点,胰岛素前体纯度可高于90%,宿主细胞蛋白去除率高于90%,外源性DNA去除率达到89%及以上、低于0.1ng/mg。

Description

PCT国内申请,说明书已公开。

Claims (17)

  1. PCT国内申请,权利要求书已公开。
CN201980008838.6A 2018-05-24 2019-05-23 一种重组人胰岛素或其类似物的前体的制备方法 Pending CN111601819A (zh)

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CN2018105079287 2018-05-24
CN201810507928 2018-05-24
PCT/CN2019/088083 WO2019223752A1 (zh) 2018-05-24 2019-05-23 一种重组人胰岛素或其类似物的前体的制备方法

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CN111601819A true CN111601819A (zh) 2020-08-28

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US (1) US20210198311A1 (zh)
EP (1) EP3805257A4 (zh)
JP (1) JP2021524464A (zh)
KR (1) KR20210016400A (zh)
CN (1) CN111601819A (zh)
AU (1) AU2019272401A1 (zh)
BR (1) BR112020023485A2 (zh)
CA (1) CA3100869A1 (zh)
TW (1) TWI742377B (zh)
WO (1) WO2019223752A1 (zh)
ZA (1) ZA202007812B (zh)

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WO2020097876A1 (zh) * 2018-11-15 2020-05-22 中国科学院大连化学物理研究所 一种多级孔ts-1分子筛的制备方法
EP3862320A4 (en) * 2018-11-15 2021-11-03 Dalian Institute Of Chemical Physics, Chinese Academy Of Sciences METHOD OF PREPARING A TS-1 HIERARCHICAL MOLECULAR SIEVE
CN113563413A (zh) * 2021-08-17 2021-10-29 汉肽生物医药集团有限公司 毕赤酵母高密度发酵过程中色素的去除方法

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WO2019223752A1 (zh) 2019-11-28
EP3805257A1 (en) 2021-04-14
CA3100869A1 (en) 2019-11-28
KR20210016400A (ko) 2021-02-15
US20210198311A1 (en) 2021-07-01
EP3805257A4 (en) 2022-03-16
ZA202007812B (en) 2021-10-27
BR112020023485A2 (pt) 2021-03-30
JP2021524464A (ja) 2021-09-13
AU2019272401A1 (en) 2021-01-14
TW202012433A (zh) 2020-04-01

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