JP7106523B2 - 組換え治療用タンパク質を含む流体を処理する方法およびその使用 - Google Patents

組換え治療用タンパク質を含む流体を処理する方法およびその使用 Download PDF

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JP7106523B2
JP7106523B2 JP2019508971A JP2019508971A JP7106523B2 JP 7106523 B2 JP7106523 B2 JP 7106523B2 JP 2019508971 A JP2019508971 A JP 2019508971A JP 2019508971 A JP2019508971 A JP 2019508971A JP 7106523 B2 JP7106523 B2 JP 7106523B2
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JP2019532916A5 (enExample
JP2019532916A (ja
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タール・ヴェター
マイケル・クールボー
ヴィーナ・ワリコー
コンスタンティン・コンスタンティノフ
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Genzyme Corp
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/58—Multistep processes
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • 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
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/06—Submerged-type; Immersion type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/16—Diafiltration
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific

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  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • External Artificial Organs (AREA)
JP2019508971A 2016-08-16 2017-08-15 組換え治療用タンパク質を含む流体を処理する方法およびその使用 Active JP7106523B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022082749A JP2022110128A (ja) 2016-08-16 2022-05-20 組換え治療用タンパク質を含む流体を処理する方法およびその使用
JP2024050645A JP2024079790A (ja) 2016-08-16 2024-03-27 組換え治療用タンパク質を含む流体を処理する方法およびその使用

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662375689P 2016-08-16 2016-08-16
US62/375,689 2016-08-16
PCT/US2017/046930 WO2018035116A1 (en) 2016-08-16 2017-08-15 Methods of processing a fluid including a recombinant therapeutic protein and use thereof

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JP2022082749A Division JP2022110128A (ja) 2016-08-16 2022-05-20 組換え治療用タンパク質を含む流体を処理する方法およびその使用

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JP2019532916A JP2019532916A (ja) 2019-11-14
JP2019532916A5 JP2019532916A5 (enExample) 2020-09-17
JP7106523B2 true JP7106523B2 (ja) 2022-07-26

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JP2019508971A Active JP7106523B2 (ja) 2016-08-16 2017-08-15 組換え治療用タンパク質を含む流体を処理する方法およびその使用
JP2022082749A Pending JP2022110128A (ja) 2016-08-16 2022-05-20 組換え治療用タンパク質を含む流体を処理する方法およびその使用
JP2024050645A Pending JP2024079790A (ja) 2016-08-16 2024-03-27 組換え治療用タンパク質を含む流体を処理する方法およびその使用

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JP2024050645A Pending JP2024079790A (ja) 2016-08-16 2024-03-27 組換え治療用タンパク質を含む流体を処理する方法およびその使用

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US (2) US10968252B2 (enExample)
EP (2) EP3950702A1 (enExample)
JP (3) JP7106523B2 (enExample)
KR (1) KR102465761B1 (enExample)
CN (1) CN109843906B (enExample)
AU (1) AU2017313042A1 (enExample)
BR (1) BR112019003013A2 (enExample)
CA (1) CA3034092A1 (enExample)
MX (2) MX2019001859A (enExample)
RU (2) RU2751506C2 (enExample)
SG (1) SG11201901220XA (enExample)
TW (1) TWI767930B (enExample)
WO (1) WO2018035116A1 (enExample)

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TWI767930B (zh) 2016-08-16 2022-06-21 美商健臻公司 處理包括重組治療性蛋白之流體的方法及其用途
SG11202003440SA (en) * 2017-11-16 2020-05-28 Chromacon Ag Method for monitoring, evaluating, and controlling a cyclic chromatographic purification process
TWI846694B (zh) * 2018-05-04 2024-07-01 美商健臻公司 具有過濾系統的灌注式生物反應器
MX2021010891A (es) 2019-03-11 2021-12-10 Genzyme Corp Filtracion tangencial de virus.
KR20210148274A (ko) * 2019-04-01 2021-12-07 베링거 인겔하임 인터내셔날 게엠베하 통합된 연속적인 재조합 단백질의 제조
AU2020253381A1 (en) 2019-04-03 2021-12-02 Genzyme Corporation Continuous production of recombinant proteins
WO2020258515A1 (zh) * 2019-06-28 2020-12-30 浙江大学 多柱连续流层析设计及分析的方法
TW202532844A (zh) * 2019-09-23 2025-08-16 美商健臻公司 用於測量生物樣品的分析物的多個產品品質屬性的方法
AU2020372397A1 (en) 2019-10-22 2022-06-09 Genzyme Corporation In-line product monitoring in integrated continuous bio-manufacturing
AU2021340897B2 (en) * 2020-09-14 2023-05-25 Enquyst Technologies Inc. Process technology for biological product manufacturing and downstream purification
US12458908B2 (en) * 2020-11-30 2025-11-04 PAK Biosolutions Inc. End-to-end continuous purification system
KR20240039642A (ko) * 2022-09-19 2024-03-27 주식회사 녹십자 신규 헤파란-n-설파타아제의 정제 방법
WO2024072963A1 (en) 2022-09-28 2024-04-04 Genzyme Corporation Systems and devices for producing biological products and methods of using the same
EP4397323A1 (de) * 2023-01-09 2024-07-10 Sartorius Stedim Biotech GmbH Verfahren zur inaktivierung von viren in einem fluid

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JP2003012693A (ja) 2000-11-03 2003-01-15 Millipore Corp 蛋白質溶液から蛋白質凝集体及びウイルスを除去する方法
JP2008512473A (ja) 2004-09-09 2008-04-24 ジェネンテック・インコーポレーテッド 抗体濃縮法とその治療用製品
JP2015533378A (ja) 2012-10-30 2015-11-24 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ ２段階接線流限外濾過を使用するポリペプチドの精製
JP2016510981A (ja) 2013-03-08 2016-04-14 ジェンザイム・コーポレーション 治療用タンパク質の連続的な精製

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JP2003012693A (ja) 2000-11-03 2003-01-15 Millipore Corp 蛋白質溶液から蛋白質凝集体及びウイルスを除去する方法
JP2008512473A (ja) 2004-09-09 2008-04-24 ジェネンテック・インコーポレーテッド 抗体濃縮法とその治療用製品
JP2015533378A (ja) 2012-10-30 2015-11-24 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ ２段階接線流限外濾過を使用するポリペプチドの精製
JP2016510981A (ja) 2013-03-08 2016-04-14 ジェンザイム・コーポレーション 治療用タンパク質の連続的な精製

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Publication number Publication date
BR112019003013A2 (pt) 2019-05-14
RU2019107142A3 (enExample) 2020-12-17
EP3950702A1 (en) 2022-02-09
RU2021119421A (ru) 2021-07-13
MX2021015165A (es) 2022-01-18
EP3500589A1 (en) 2019-06-26
AU2017313042A1 (en) 2019-04-04
EP3500589B1 (en) 2022-05-04
TW201811816A (zh) 2018-04-01
RU2019107142A (ru) 2020-09-18
CN109843906B (zh) 2023-09-01
US10968252B2 (en) 2021-04-06
JP2019532916A (ja) 2019-11-14
US11884703B2 (en) 2024-01-30
WO2018035116A1 (en) 2018-02-22
TWI767930B (zh) 2022-06-21
RU2751506C2 (ru) 2021-07-14
SG11201901220XA (en) 2019-03-28
JP2024079790A (ja) 2024-06-11
KR102465761B1 (ko) 2022-11-09
CA3034092A1 (en) 2018-02-22
US20180051054A1 (en) 2018-02-22
CN109843906A (zh) 2019-06-04
MX2019001859A (es) 2019-08-29
US20210171572A1 (en) 2021-06-10
JP2022110128A (ja) 2022-07-28
KR20190046872A (ko) 2019-05-07

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