CA3034092A1 - 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 Download PDF

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Publication number
CA3034092A1
CA3034092A1 CA3034092A CA3034092A CA3034092A1 CA 3034092 A1 CA3034092 A1 CA 3034092A1 CA 3034092 A CA3034092 A CA 3034092A CA 3034092 A CA3034092 A CA 3034092A CA 3034092 A1 CA3034092 A1 CA 3034092A1
Authority
CA
Canada
Prior art keywords
minute
hours
kda
therapeutic protein
fluid
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CA3034092A
Other languages
English (en)
French (fr)
Inventor
Tarl VETTER
Michael COOLBAUGH
Veena WARIKOO
Konstantin Konstantinov
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Genzyme Corp
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 CA3034092A1 publication Critical patent/CA3034092A1/en
Pending legal-status Critical Current

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 [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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)
  • 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)
  • External Artificial Organs (AREA)
CA3034092A 2016-08-16 2017-08-15 Methods of processing a fluid including a recombinant therapeutic protein and use thereof Pending CA3034092A1 (en)

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
CA3034092A1 true CA3034092A1 (en) 2018-02-22

Family

ID=59799450

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3034092A Pending CA3034092A1 (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) 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)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102465761B1 (ko) 2016-08-16 2022-11-09 젠자임 코포레이션 재조합 치료 단백질을 포함하는 유체의 처리 방법 및 상기 유체의 용도
JP7333779B2 (ja) * 2017-11-16 2023-08-25 クロマコン アーゲー 循環クロマトグラフィー精製プロセスを監視、評価及び制御する方法
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
WO2020185825A1 (en) 2019-03-11 2020-09-17 Genzyme Corporation Tangential viral filtration
AU2020253327B2 (en) * 2019-04-01 2025-04-10 Boehringer Ingelheim International Gmbh Integrated and continuous recombinant protein manufacturing
CN113825840A (zh) 2019-04-03 2021-12-21 建新公司 重组蛋白的连续生产
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
KR20220069053A (ko) * 2019-09-23 2022-05-26 젠자임 코포레이션 제품 품질 특성 측정
CA3155216A1 (en) 2019-10-22 2021-04-29 Robert Snow In-line product monitoring in integrated continuous bio-manufacturing
CN116367903B (zh) * 2020-09-14 2024-10-25 恩奎斯特技术公司 生物制剂制造及下游纯化工艺技术
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
CN119968454A (zh) 2022-09-28 2025-05-09 建新公司 用于生产生物产品的系统和装置及其使用方法
EP4397323A1 (de) * 2023-01-09 2024-07-10 Sartorius Stedim Biotech GmbH Verfahren zur inaktivierung von viren in einem fluid

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
AU2954502A (en) 2000-11-13 2002-05-21 Bayer Ag Method of inactivating microorganisms in a fluid using ultraviolet radiation
SI1501369T1 (sl) * 2002-04-26 2015-10-30 Genentech, Inc. Neafinitetno čiščenje proteinov
US20060051347A1 (en) 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
US7510654B2 (en) * 2005-12-29 2009-03-31 Spf Innovations, Llc Method and apparatus for the filtration of biological samples
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
WO2010120514A2 (en) 2009-03-31 2010-10-21 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
SI2914612T1 (sl) * 2012-10-30 2019-03-29 F. Hoffmann-La Roche Ag Čiščenje polipeptidov z uporabo dvostopenjske tangencialne ultrafiltracije
EP2935319B1 (en) * 2012-12-18 2019-04-24 Novartis AG Production of therapeutic proteins in genetically modified mammalian cells
AU2014226126B2 (en) 2013-03-08 2019-02-14 Genzyme Corporation Continuous purification of therapeutic proteins
KR102465761B1 (ko) 2016-08-16 2022-11-09 젠자임 코포레이션 재조합 치료 단백질을 포함하는 유체의 처리 방법 및 상기 유체의 용도

Also Published As

Publication number Publication date
US11884703B2 (en) 2024-01-30
EP3500589A1 (en) 2019-06-26
CN109843906A (zh) 2019-06-04
US20210171572A1 (en) 2021-06-10
WO2018035116A1 (en) 2018-02-22
EP3500589B1 (en) 2022-05-04
MX2021015165A (es) 2022-01-18
RU2751506C2 (ru) 2021-07-14
SG11201901220XA (en) 2019-03-28
BR112019003013A2 (pt) 2019-05-14
RU2019107142A3 (enExample) 2020-12-17
US20180051054A1 (en) 2018-02-22
MX2019001859A (es) 2019-08-29
RU2021119421A (ru) 2021-07-13
AU2017313042A1 (en) 2019-04-04
EP3950702A1 (en) 2022-02-09
RU2019107142A (ru) 2020-09-18
US10968252B2 (en) 2021-04-06
TWI767930B (zh) 2022-06-21
KR20190046872A (ko) 2019-05-07
JP2019532916A (ja) 2019-11-14
KR102465761B1 (ko) 2022-11-09
JP2022110128A (ja) 2022-07-28
CN109843906B (zh) 2023-09-01
JP7106523B2 (ja) 2022-07-26
JP2024079790A (ja) 2024-06-11
TW201811816A (zh) 2018-04-01

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