SG11201901220XA - Methods of processing a fluid including a recombinant therapeutic protein and use thereof - Google Patents

Methods of processing a fluid including a recombinant therapeutic protein and use thereof

Info

Publication number
SG11201901220XA
SG11201901220XA SG11201901220XA SG11201901220XA SG11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA
Authority
SG
Singapore
Prior art keywords
international
therapeutic protein
rule
processing
methods
Prior art date
Application number
SG11201901220XA
Other languages
English (en)
Inventor
Tarl Vetter
Michael Coolbaugh
Veena Warikoo
Konstantin Konstantinov
Original Assignee
Genzyme Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Genzyme Corp filed Critical Genzyme Corp
Publication of SG11201901220XA publication Critical patent/SG11201901220XA/en

Links

Classifications

    • 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
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • 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
    • B01D61/14Ultrafiltration; Microfiltration
    • B01D61/145Ultrafiltration
    • 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
    • B01D61/14Ultrafiltration; Microfiltration
    • B01D61/145Ultrafiltration
    • B01D61/146Ultrafiltration comprising multiple ultrafiltration steps
    • 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
    • B01D61/58Multistep processes
    • 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
    • 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
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2315/00Details relating to the membrane module operation
    • B01D2315/06Submerged-type; Immersion type
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2315/00Details relating to the membrane module operation
    • B01D2315/16Diafiltration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific

Landscapes

  • 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)
  • Treatment Of Liquids With Adsorbents In General (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)
  • External Artificial Organs (AREA)
SG11201901220XA 2016-08-16 2017-08-15 Methods of processing a fluid including a recombinant therapeutic protein and use thereof SG11201901220XA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662375689P 2016-08-16 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

Publications (1)

Publication Number Publication Date
SG11201901220XA true SG11201901220XA (en) 2019-03-28

Family

ID=59799450

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201901220XA SG11201901220XA (en) 2016-08-16 2017-08-15 Methods of processing a fluid including a recombinant therapeutic protein and use thereof

Country Status (13)

Country Link
US (2) US10968252B2 (enExample)
EP (2) EP3500589B1 (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) RU2021119421A (enExample)
SG (1) SG11201901220XA (enExample)
TW (1) TWI767930B (enExample)
WO (1) WO2018035116A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3500589B1 (en) 2016-08-16 2022-05-04 Genzyme Corporation Methods of processing a fluid including a recombinant therapeutic protein and use thereof
PT3512616T (pt) * 2017-11-16 2020-01-29 Chromacon Ag Método para monitorizar, avaliar, e controlar um processo de purificação cromatográfica cíclica
TWI898645B (zh) 2018-05-04 2025-09-21 美商健臻公司 灌注式細胞培養裝置
AU2020237461A1 (en) 2019-03-11 2021-11-04 Genzyme Corporation Tangential viral filtration
CA3131430A1 (en) * 2019-04-01 2020-10-08 Boehringer Ingelheim International Gmbh Integrated and continuous recombinant protein manufacturing
EP3947705A1 (en) * 2019-04-03 2022-02-09 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
AU2020352519A1 (en) * 2019-09-23 2022-05-19 Genzyme Corporation Product quality attribute measurement
TW202134631A (zh) 2019-10-22 2021-09-16 美商健臻公司 整合式連續生物製造中的線上產品監測
IL301301A (en) * 2020-09-14 2023-05-01 Enquyst Tech Inc Process technology for the production of biological products 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
EP4594462A1 (en) 2022-09-28 2025-08-06 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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Publication number Priority date Publication date Assignee Title
CH692479A5 (de) * 1997-07-08 2002-07-15 Bucher Guyer Ag Querstrom-Filtrationsanlage sowie Verfahren zum Betrieb einer solchen Anlage.
GB9821342D0 (en) 1998-10-02 1998-11-25 Common Services Agency Device for treatment of biological fluids
US6214221B1 (en) * 1999-02-22 2001-04-10 Henry B. Kopf Method and apparatus for purification of biological substances
US6296770B1 (en) * 1999-12-09 2001-10-02 Eastman Kodak Company Constant concentration at the UF membrane wall UF process control and apparatus
US6365395B1 (en) * 2000-11-03 2002-04-02 Millipore Corporation Process for removing protein aggregates and virus from a protein solution
DK1337280T3 (da) 2000-11-13 2013-12-02 Bayer Ip Gmbh Fremgangsmåde til inaktivering af mikroorganismer i en fluid ved anvendelse af ultraviolet stråling
JP4319979B2 (ja) * 2002-04-26 2009-08-26 ジェネンテック・インコーポレーテッド タンパク質の非アフィニティ精製
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
US7384549B2 (en) * 2005-12-29 2008-06-10 Spf Innovations, Llc Method and apparatus for the filtration of biological solutions
US20080017576A1 (en) * 2006-06-15 2008-01-24 Rensselaer Polytechnic Institute Global model for optimizing crossflow microfiltration and ultrafiltration processes
US20080207487A1 (en) * 2006-11-02 2008-08-28 Neose Technologies, Inc. Manufacturing process for the production of polypeptides expressed in insect cell-lines
US7988859B2 (en) 2009-02-05 2011-08-02 Chromatan Inc. Countercurrent tangential chromatography methods, systems, and apparatus
US20100237013A1 (en) * 2009-02-13 2010-09-23 Millipore Corporation Autonomous filter element
US8728479B2 (en) 2009-03-31 2014-05-20 The Trustees Of The University Of Pennsylvania Antigen-binding proteins comprising recombinant protein scaffolds
EP2509873B1 (en) 2009-12-11 2019-03-20 Wyssmont Company Inc. Apparatus and method for continuous lyophilization
BR112015009553A2 (pt) * 2012-10-30 2017-10-03 Hoffmann La Roche Método para separar uma proteína de interesse de uma solução de cultura de células
EP2935319B1 (en) * 2012-12-18 2019-04-24 Novartis AG Production of therapeutic proteins in genetically modified mammalian cells
IL274646B (en) * 2013-03-08 2022-09-01 Genzyme Corp Integrated continuous production of medicinal substances from medical protein
EP3500589B1 (en) 2016-08-16 2022-05-04 Genzyme Corporation Methods of processing a fluid including a recombinant therapeutic protein and use thereof

Also Published As

Publication number Publication date
RU2751506C2 (ru) 2021-07-14
RU2021119421A (ru) 2021-07-13
RU2019107142A (ru) 2020-09-18
JP7106523B2 (ja) 2022-07-26
JP2024079790A (ja) 2024-06-11
WO2018035116A1 (en) 2018-02-22
CN109843906B (zh) 2023-09-01
US11884703B2 (en) 2024-01-30
EP3500589B1 (en) 2022-05-04
RU2019107142A3 (enExample) 2020-12-17
CA3034092A1 (en) 2018-02-22
KR20190046872A (ko) 2019-05-07
TWI767930B (zh) 2022-06-21
US10968252B2 (en) 2021-04-06
US20210171572A1 (en) 2021-06-10
JP2022110128A (ja) 2022-07-28
AU2017313042A1 (en) 2019-04-04
TW201811816A (zh) 2018-04-01
CN109843906A (zh) 2019-06-04
MX2019001859A (es) 2019-08-29
BR112019003013A2 (pt) 2019-05-14
KR102465761B1 (ko) 2022-11-09
EP3950702A1 (en) 2022-02-09
EP3500589A1 (en) 2019-06-26
US20180051054A1 (en) 2018-02-22
JP2019532916A (ja) 2019-11-14
MX2021015165A (es) 2022-01-18

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