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)
  • 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)
  • 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 (3) 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) RU2751506C2 (pt)
SG (1) SG11201901220XA (pt)
TW (1) TWI767930B (pt)
WO (1) WO2018035116A1 (pt)

Families Citing this family (9)

* 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
DK3512616T4 (da) * 2017-11-16 2022-09-19 Chromacon Ag Fremgangsmåde til at overvåge, evaluere og styre en cyklisk kromatografisk oprensningsproces
WO2019213567A1 (en) * 2018-05-04 2019-11-07 Genzyme Corporation Perfusion bioreactor with filtration systems
TW202100248A (zh) 2019-03-11 2021-01-01 美商健臻公司 切向式病毒過濾
MX2021012078A (es) * 2019-04-03 2022-01-04 Genzyme Corp Produccion continua de proteinas recombinantes.
WO2021081055A1 (en) 2019-10-22 2021-04-29 Genzyme Corporation In-line product monitoring in integrated continuous bio-manufacturing
US20220168668A1 (en) * 2020-11-30 2022-06-02 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
EP4397323A1 (de) * 2023-01-09 2024-07-10 Sartorius Stedim Biotech GmbH Verfahren zur inaktivierung von viren in einem fluid

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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
AU2002229545B2 (en) 2000-11-13 2007-08-30 Bayer Aktiengesellschaft Method of inactivating microorganisms in a fluid using ultraviolet radiation
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
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US20100237013A1 (en) * 2009-02-13 2010-09-23 Millipore Corporation Autonomous filter element
WO2010120514A2 (en) 2009-03-31 2010-10-21 The Trustees Of The University Of Pennsylvania Antigen-binding proteins comprising recombinant protein scaffolds
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RU2632568C2 (ru) * 2012-10-30 2017-10-05 Ф.Хоффманн-Ля Рош Аг Очистка полипептидов с использованием двухстадийной ультрафильтрации в тангенциальном потоке
ES2738641T3 (es) * 2012-12-18 2020-01-24 Novartis Ag Producción de proteínas terapéuticas en células de mamífero modificadas genéticamente
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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
US10968252B2 (en) 2021-04-06
CN109843906A (zh) 2019-06-04
TW201811816A (zh) 2018-04-01
RU2019107142A3 (pt) 2020-12-17
CA3034092A1 (en) 2018-02-22
CN109843906B (zh) 2023-09-01
RU2019107142A (ru) 2020-09-18
US11884703B2 (en) 2024-01-30
RU2751506C2 (ru) 2021-07-14
JP7106523B2 (ja) 2022-07-26
SG11201901220XA (en) 2019-03-28
MX2019001859A (es) 2019-08-29
KR102465761B1 (ko) 2022-11-09
JP2022110128A (ja) 2022-07-28
WO2018035116A1 (en) 2018-02-22
TWI767930B (zh) 2022-06-21
KR20190046872A (ko) 2019-05-07
EP3950702A1 (en) 2022-02-09
US20180051054A1 (en) 2018-02-22
MX2021015165A (es) 2022-01-18
RU2021119421A (ru) 2021-07-13
US20210171572A1 (en) 2021-06-10
AU2017313042A1 (en) 2019-04-04
EP3500589A1 (en) 2019-06-26
JP2024079790A (ja) 2024-06-11
JP2019532916A (ja) 2019-11-14
EP3500589B1 (en) 2022-05-04

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Legal Events

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B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]