IL275533B2 - Adeno-associated virus purification methods - Google Patents

Adeno-associated virus purification methods

Info

Publication number
IL275533B2
IL275533B2 IL275533A IL27553320A IL275533B2 IL 275533 B2 IL275533 B2 IL 275533B2 IL 275533 A IL275533 A IL 275533A IL 27553320 A IL27553320 A IL 27553320A IL 275533 B2 IL275533 B2 IL 275533B2
Authority
IL
Israel
Prior art keywords
buffer
affinity resin
wash step
comprises applying
hcl
Prior art date
Application number
IL275533A
Other languages
English (en)
Hebrew (he)
Other versions
IL275533B1 (en
IL275533A (en
Original Assignee
Baxalta Inc
Baxalta GmbH
Takeda Pharmaceuticals Co
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 Baxalta Inc, Baxalta GmbH, Takeda Pharmaceuticals Co filed Critical Baxalta Inc
Publication of IL275533A publication Critical patent/IL275533A/en
Publication of IL275533B1 publication Critical patent/IL275533B1/en
Publication of IL275533B2 publication Critical patent/IL275533B2/en

Links

Classifications

    • 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
    • B01D15/16Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166Fluid composition conditioning, e.g. gradient
    • 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
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • 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
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804Affinity chromatography
    • B01D15/3809Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • 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
    • B01D15/42Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424Elution mode
    • B01D15/426Specific type of solvent
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86Viral vectors
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983Viruses
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2750/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011Details
    • C12N2750/14011Parvoviridae
    • C12N2750/14111Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14141Use of virus, viral particle or viral elements as a vector
    • C12N2750/14143Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2750/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011Details
    • C12N2750/14011Parvoviridae
    • C12N2750/14111Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14151Methods of production or purification of viral material
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/01DNA viruses
    • G01N2333/075Adenoviridae

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Plant Pathology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicinal Preparation (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
IL275533A 2017-12-29 2018-12-27 Adeno-associated virus purification methods IL275533B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762611709P 2017-12-29 2017-12-29
PCT/US2018/067627 WO2019133677A1 (en) 2017-12-29 2018-12-27 Adeno-associated virus purification methods

Publications (3)

Publication Number Publication Date
IL275533A IL275533A (en) 2020-08-31
IL275533B1 IL275533B1 (en) 2024-11-01
IL275533B2 true IL275533B2 (en) 2025-03-01

Family

ID=67064154

Family Applications (1)

Application Number Title Priority Date Filing Date
IL275533A IL275533B2 (en) 2017-12-29 2018-12-27 Adeno-associated virus purification methods

Country Status (12)

Country Link
US (1) US11981934B2 (https=)
EP (1) EP3731863A4 (https=)
JP (2) JP7299896B2 (https=)
KR (1) KR20200106045A (https=)
CN (1) CN111655285B (https=)
AU (1) AU2018395254B2 (https=)
BR (1) BR112020013197A8 (https=)
CA (1) CA3084827A1 (https=)
IL (1) IL275533B2 (https=)
MX (1) MX2020006884A (https=)
SG (1) SG11202006232SA (https=)
WO (1) WO2019133677A1 (https=)

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AU2019299964A1 (en) * 2018-07-11 2021-01-21 Takeda Pharmaceutical Company Limited AAV compositions
EP3990031A4 (en) * 2019-06-28 2023-08-09 Takeda Pharmaceutical Company Limited Adeno-associated virus purification methods
EP3868886A1 (en) * 2020-02-21 2021-08-25 Bia Separations D.O.O. A method for separation or depletion of empty aav capsids from full aav capsids
US20220033782A1 (en) * 2020-07-29 2022-02-03 Pall Corporation Adenovirus-associated viruses separation method
JP2023539163A (ja) * 2020-08-18 2023-09-13 ザルトリウス ビーアイエー セパレーションズ ディー.オー.オー. 宿主細胞dnaの金属アフィニティー抽出
JP2023548816A (ja) * 2020-11-03 2023-11-21 ファイザー・インク 陰イオン交換クロマトグラフィーによるaavベクターの精製方法
US20230416693A1 (en) * 2020-11-24 2023-12-28 Sartorius Bia Separations D.O.O. Improved washing methods for affinity chromatography
JP2024503234A (ja) * 2020-12-23 2024-01-25 ファイザー・インク 親和性クロマトグラフィーによるaavベクターの精製方法
EP4281552A4 (en) * 2021-01-21 2025-03-12 AskBio Inc. Method for purifying recombinant viral particles
WO2022222869A1 (zh) * 2021-04-19 2022-10-27 信念医药(香港)有限公司 重组腺相关病毒及其应用
CN114591921B (zh) * 2022-03-31 2024-08-02 上海勉亦生物科技有限公司 腺相关病毒的纯化方法和洗脱液
GB202110014D0 (en) * 2021-07-12 2021-08-25 Cytiva Bioprocess R & D Ab A method for separating adeno-associated virus capsids, compositions obtained by said method and uses thereof
CN113552349B (zh) * 2021-07-30 2022-07-19 上海勉亦生物科技有限公司 Aav蛋白外壳的检测方法
US20230183659A1 (en) * 2021-10-29 2023-06-15 Homology Medicines, Inc. Methods and compositions for the purification of adeno-associated virus
CN114350622A (zh) * 2022-01-17 2022-04-15 苏州博腾生物制药有限公司 一种病毒纯化高效保护试剂及其应用
EP4490179A1 (en) 2022-03-07 2025-01-15 Takeda Pharmaceutical Company Limited Affinity chromatographic production of clinical human igg products
GB202206123D0 (en) * 2022-04-27 2022-06-08 Cytiva Bioprocess R & D Ab A pre-screening method and a method for separating adeno-associated virus capsids
WO2024233992A2 (en) * 2023-05-11 2024-11-14 Trophogen, Inc. Methods of manufacturing highly glycosylated glycoprotein hormones and their analogs
WO2025027058A1 (en) * 2023-08-01 2025-02-06 Merck Patent Gmbh Polishing for aav particles using anion exchange chromatography with improved elution system
WO2025104341A1 (en) * 2023-11-16 2025-05-22 Sartorius Bia Separations D.O.O. Enhanced chromatographic separation of components in a mixture by employing decreasing gradient of complexing agent
WO2025207456A1 (en) * 2024-03-25 2025-10-02 Frontera Therapeutics, Inc. Methods for purification of adeno associated virus particles by anion exchange chromatography
WO2026077794A1 (en) * 2024-10-07 2026-04-16 Cytiva Us Llc Plasmid purification methods

Citations (5)

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WO2002012455A1 (en) * 2000-08-07 2002-02-14 Avigen, Inc. LARGE-SCALE RECOMBINANT ADENO-ASSOCIATED VIRUS (rAAV) PRODUCTION AND PURIFICATION
US20150275195A1 (en) * 2012-10-24 2015-10-01 Genzyme Corporation Elution of biomolecules from multi-modal resins using mes and mops as mobile phase modifiers
WO2016128408A1 (en) * 2015-02-09 2016-08-18 Institut National De La Sante Et De La Recherche Medicale (Inserm) Recombinant adeno-associated virus particle purification comprising an affinity purification step
WO2017100676A1 (en) * 2015-12-11 2017-06-15 The Trustees Of The University Of Pennsylvania Scalable purification method for aav8
WO2017160360A2 (en) * 2015-12-11 2017-09-21 The Trustees Of The University Of Pennsylvania Scalable purification method for aav9

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WO2002012455A1 (en) * 2000-08-07 2002-02-14 Avigen, Inc. LARGE-SCALE RECOMBINANT ADENO-ASSOCIATED VIRUS (rAAV) PRODUCTION AND PURIFICATION
US20030207439A1 (en) * 2000-08-07 2003-11-06 Wright John Fraser Large-scale recombinant adeno-associated virus (rAAV) production and purification
US20150275195A1 (en) * 2012-10-24 2015-10-01 Genzyme Corporation Elution of biomolecules from multi-modal resins using mes and mops as mobile phase modifiers
WO2016128408A1 (en) * 2015-02-09 2016-08-18 Institut National De La Sante Et De La Recherche Medicale (Inserm) Recombinant adeno-associated virus particle purification comprising an affinity purification step
WO2017100676A1 (en) * 2015-12-11 2017-06-15 The Trustees Of The University Of Pennsylvania Scalable purification method for aav8
WO2017160360A2 (en) * 2015-12-11 2017-09-21 The Trustees Of The University Of Pennsylvania Scalable purification method for aav9

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Also Published As

Publication number Publication date
MX2020006884A (es) 2020-10-01
KR20200106045A (ko) 2020-09-10
EP3731863A1 (en) 2020-11-04
JP2023089298A (ja) 2023-06-27
JP7299896B2 (ja) 2023-06-28
SG11202006232SA (en) 2020-07-29
RU2020124946A (ru) 2022-01-31
WO2019133677A1 (en) 2019-07-04
BR112020013197A2 (pt) 2021-02-17
AU2018395254A1 (en) 2020-06-25
CA3084827A1 (en) 2019-07-04
US11981934B2 (en) 2024-05-14
US20200332266A1 (en) 2020-10-22
EP3731863A4 (en) 2021-10-27
AU2018395254B2 (en) 2024-07-25
IL275533B1 (en) 2024-11-01
CN111655285A (zh) 2020-09-11
JP2021508484A (ja) 2021-03-11
BR112020013197A8 (pt) 2022-11-08
JP7531654B2 (ja) 2024-08-09
IL275533A (en) 2020-08-31
RU2020124946A3 (https=) 2022-02-08
CN111655285B (zh) 2025-02-25

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