CN105263947A - 单克隆抗体的纯化工艺 - Google Patents

单克隆抗体的纯化工艺 Download PDF

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Publication number
CN105263947A
CN105263947A CN201480031532.XA CN201480031532A CN105263947A CN 105263947 A CN105263947 A CN 105263947A CN 201480031532 A CN201480031532 A CN 201480031532A CN 105263947 A CN105263947 A CN 105263947A
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China
Prior art keywords
antibody
column
chromatography
protein
wash
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Pending
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CN201480031532.XA
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English (en)
Chinese (zh)
Inventor
桑吉乌·库马尔·门迪拉塔
桑贾伊·班迪奥帕迪亚伊
阿万尼什·库马尔·辛格
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Zydus Lifesciences Ltd
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Cadila Healthcare Ltd
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Application filed by Cadila Healthcare Ltd filed Critical Cadila Healthcare Ltd
Publication of CN105263947A publication Critical patent/CN105263947A/zh
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Oncology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cell Biology (AREA)
CN201480031532.XA 2013-06-25 2014-06-25 单克隆抗体的纯化工艺 Pending CN105263947A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2145/MUM/2013 2013-06-25
PCT/IN2014/000421 WO2014207763A1 (en) 2013-06-25 2014-06-25 Purification process for monoclonal antibodies
IN2145MU2013 IN2013MU02145A (https=) 2013-06-25 2014-06-25

Publications (1)

Publication Number Publication Date
CN105263947A true CN105263947A (zh) 2016-01-20

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CN201480031532.XA Pending CN105263947A (zh) 2013-06-25 2014-06-25 单克隆抗体的纯化工艺

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Country Link
US (1) US9708365B2 (https=)
EP (1) EP3013849B1 (https=)
JP (1) JP6039828B2 (https=)
KR (1) KR101683415B1 (https=)
CN (1) CN105263947A (https=)
AR (1) AR096713A1 (https=)
AU (1) AU2014300486B2 (https=)
BR (1) BR112015031196A2 (https=)
CA (1) CA2911874A1 (https=)
EA (1) EA201592192A1 (https=)
HK (1) HK1217344A1 (https=)
IL (1) IL242649A (https=)
IN (1) IN2013MU02145A (https=)
MX (1) MX350610B (https=)
NZ (1) NZ714079A (https=)
SG (1) SG11201509502XA (https=)
TW (1) TWI596107B (https=)
WO (1) WO2014207763A1 (https=)
ZA (1) ZA201508258B (https=)

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CN107849087A (zh) * 2015-08-21 2018-03-27 豪夫迈·罗氏有限公司 在亲和层析中减少宿主细胞蛋白的方法
CN109336969A (zh) * 2018-11-09 2019-02-15 杭州奕安济世生物药业有限公司 一种抗体的纯化方法
CN110128538A (zh) * 2018-02-09 2019-08-16 鲁南制药集团股份有限公司 一种纯化抗cd20人鼠嵌合单克隆抗体的方法
CN111072773A (zh) * 2018-10-19 2020-04-28 菲鹏生物股份有限公司 抗体的纯化方法、抗体和应用
CN114133446A (zh) * 2021-12-31 2022-03-04 方坦思(上海)生物医药有限公司 单克隆抗体的纯化方法
CN118725127A (zh) * 2024-07-11 2024-10-01 信立泰(苏州)药业有限公司 一种抗pcsk9单克隆抗体的分离纯化方法

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CN108101987A (zh) * 2017-11-17 2018-06-01 安徽未名生物医药有限公司 一种重组抗TNF-α全人源单克隆抗体的纯化方法
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KR102337683B1 (ko) * 2018-09-21 2021-12-13 주식회사 녹십자 고효율 항-tfpi 항체 조성물
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CN109320611B (zh) * 2018-10-31 2022-06-03 鼎康(武汉)生物医药有限公司 一种人鼠嵌合单克隆抗体生物类似药的纯化方法
CN111153993B (zh) * 2018-11-07 2024-06-28 正大天晴药业集团南京顺欣制药有限公司 抗TNF-α单克隆抗体的制备方法
CN111269316B (zh) * 2018-12-04 2024-06-28 正大天晴药业集团南京顺欣制药有限公司 抗her2单克隆抗体的纯化方法
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Cited By (9)

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CN107849087A (zh) * 2015-08-21 2018-03-27 豪夫迈·罗氏有限公司 在亲和层析中减少宿主细胞蛋白的方法
US12503487B2 (en) 2015-08-21 2025-12-23 Genentech, Inc. Method for the reduction of host cell proteins in affinity chromatography
CN110128538A (zh) * 2018-02-09 2019-08-16 鲁南制药集团股份有限公司 一种纯化抗cd20人鼠嵌合单克隆抗体的方法
CN110128538B (zh) * 2018-02-09 2022-08-26 鲁南制药集团股份有限公司 一种纯化抗cd20人鼠嵌合单克隆抗体的方法
CN111072773A (zh) * 2018-10-19 2020-04-28 菲鹏生物股份有限公司 抗体的纯化方法、抗体和应用
CN109336969A (zh) * 2018-11-09 2019-02-15 杭州奕安济世生物药业有限公司 一种抗体的纯化方法
CN114133446A (zh) * 2021-12-31 2022-03-04 方坦思(上海)生物医药有限公司 单克隆抗体的纯化方法
CN118725127A (zh) * 2024-07-11 2024-10-01 信立泰(苏州)药业有限公司 一种抗pcsk9单克隆抗体的分离纯化方法
CN118725127B (zh) * 2024-07-11 2025-11-28 信立泰(苏州)药业有限公司 一种抗pcsk9单克隆抗体的分离纯化方法

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Publication number Publication date
IN2013MU02145A (https=) 2015-06-05
KR101683415B1 (ko) 2016-12-06
EP3013849B1 (en) 2017-09-13
BR112015031196A2 (pt) 2017-07-25
JP6039828B2 (ja) 2016-12-07
US9708365B2 (en) 2017-07-18
EA201592192A1 (ru) 2016-07-29
HK1217344A1 (zh) 2017-01-06
AR096713A1 (es) 2016-01-27
CA2911874A1 (en) 2014-12-31
SG11201509502XA (en) 2015-12-30
WO2014207763A1 (en) 2014-12-31
ZA201508258B (en) 2017-03-29
IL242649A (en) 2016-03-31
TW201512217A (zh) 2015-04-01
JP2016525500A (ja) 2016-08-25
NZ714079A (en) 2017-05-26
MX350610B (es) 2017-09-11
KR20160003311A (ko) 2016-01-08
EP3013849A1 (en) 2016-05-04
AU2014300486A1 (en) 2015-11-26
AU2014300486B2 (en) 2016-06-30
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US20160115195A1 (en) 2016-04-28
TWI596107B (zh) 2017-08-21

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