BR112019003013A2 - métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo - Google Patents

métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo

Info

Publication number
BR112019003013A2
BR112019003013A2 BR112019003013-1A BR112019003013A BR112019003013A2 BR 112019003013 A2 BR112019003013 A2 BR 112019003013A2 BR 112019003013 A BR112019003013 A BR 112019003013A BR 112019003013 A2 BR112019003013 A2 BR 112019003013A2
Authority
BR
Brazil
Prior art keywords
therapeutic protein
methods
processing
recombinant therapeutic
fluid including
Prior art date
Application number
BR112019003013-1A
Other languages
English (en)
Inventor
Vetter Tarl
Coolbaugh Michael
Warikoo Veena
Konstantinov Konstantin
Original Assignee
Genzyme Corporation
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 Corporation filed Critical Genzyme Corporation
Publication of BR112019003013A2 publication Critical patent/BR112019003013A2/pt

Links

Classifications

    • 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
    • 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
    • C07K1/36—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

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Water Supply & Treatment (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (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)
  • External Artificial Organs (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)
  • Enzymes And Modification Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

a presente invenção refere-se a métodos de processamento de um fluido que incluem o uso tanto de um sistema de circuito incluindo uma unidade de filtragem de fluxo tangencial (tff) quanto um sistema de circuito incluindo uma unidade de filtragem de vírus de fluxo tangencial (tfvf). são ainda fornecidos processos integrados e contínuos para a fabricação de uma substância de fármaco de proteína terapêutica que incluem uma etapa de processamento de um fluido incluindo a proteína terapêutica recombinante usando qualquer um dos métodos fornecidos aqui.
BR112019003013-1A 2016-08-16 2017-08-15 métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo BR112019003013A2 (pt)

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

Publications (1)

Publication Number Publication Date
BR112019003013A2 true BR112019003013A2 (pt) 2019-05-14

Family

ID=59799450

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019003013-1A BR112019003013A2 (pt) 2016-08-16 2017-08-15 métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo

Country Status (13)

Country Link
US (2) US10968252B2 (pt)
EP (2) EP3500589B1 (pt)
JP (2) JP7106523B2 (pt)
KR (1) KR102465761B1 (pt)
CN (1) CN109843906B (pt)
AU (1) AU2017313042A1 (pt)
BR (1) BR112019003013A2 (pt)
CA (1) CA3034092A1 (pt)
MX (2) MX2019001859A (pt)
RU (2) RU2021119421A (pt)
SG (1) SG11201901220XA (pt)
TW (1) TWI767930B (pt)
WO (1) WO2018035116A1 (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10968252B2 (en) 2016-08-16 2021-04-06 Genzyme Corporation Methods of processing a fluid including a recombinant therapeutic protein and use thereof
DK3512616T4 (da) * 2017-11-16 2022-09-19 Chromacon Ag Fremgangsmåde til at overvåge, evaluere og styre en cyklisk kromatografisk oprensningsproces
TW202003832A (zh) * 2018-05-04 2020-01-16 美商健臻公司 具有過濾系統的灌注式生物反應器
CN113784779A (zh) 2019-03-11 2021-12-10 建新公司 切向病毒过滤
EP3947705A1 (en) * 2019-04-03 2022-02-09 Genzyme Corporation Continuous production of recombinant proteins
BR112022007525A2 (pt) 2019-10-22 2022-07-12 Genzyme Corp Monitoramento de produto em linha na biofabricação contínua integrada
KR20240039642A (ko) * 2022-09-19 2024-03-27 주식회사 녹십자 신규 헤파란-n-설파타아제의 정제 방법

Family Cites Families (19)

* Cited by examiner, † Cited by third party
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
WO2003102132A2 (en) * 2002-04-26 2003-12-11 Genetech, Inc. Non-affinity purification of proteins
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
WO2008073620A2 (en) * 2006-11-02 2008-06-19 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
WO2011071676A1 (en) 2009-12-11 2011-06-16 Wyssmont Company Inc. Apparatus and method for continuous lyophilization
EP2914612B1 (en) 2012-10-30 2018-11-14 F.Hoffmann-La Roche Ag Purification of polypeptides using dual stage tangential-flow ultrafiltration
US10030063B2 (en) * 2012-12-18 2018-07-24 Novartis Ag Production of therapeutic proteins in genetically modified mammalian cells
RU2768003C2 (ru) * 2013-03-08 2022-03-22 Джензим Корпорейшн Интегрированное непрерывное производство терапевтических белковых лекарственных веществ
US10968252B2 (en) 2016-08-16 2021-04-06 Genzyme Corporation Methods of processing a fluid including a recombinant therapeutic protein and use thereof

Also Published As

Publication number Publication date
JP2022110128A (ja) 2022-07-28
SG11201901220XA (en) 2019-03-28
CN109843906A (zh) 2019-06-04
CA3034092A1 (en) 2018-02-22
US20210171572A1 (en) 2021-06-10
US10968252B2 (en) 2021-04-06
US20180051054A1 (en) 2018-02-22
MX2021015165A (es) 2022-01-18
EP3500589A1 (en) 2019-06-26
MX2019001859A (es) 2019-08-29
JP7106523B2 (ja) 2022-07-26
CN109843906B (zh) 2023-09-01
EP3950702A1 (en) 2022-02-09
RU2021119421A (ru) 2021-07-13
KR20190046872A (ko) 2019-05-07
RU2751506C2 (ru) 2021-07-14
TWI767930B (zh) 2022-06-21
US11884703B2 (en) 2024-01-30
KR102465761B1 (ko) 2022-11-09
RU2019107142A (ru) 2020-09-18
WO2018035116A1 (en) 2018-02-22
AU2017313042A1 (en) 2019-04-04
JP2019532916A (ja) 2019-11-14
EP3500589B1 (en) 2022-05-04
RU2019107142A3 (pt) 2020-12-17
TW201811816A (zh) 2018-04-01

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Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]