AU2018395254B2 - Adeno-associated virus purification methods - Google Patents

Adeno-associated virus purification methods Download PDF

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Publication number
AU2018395254B2
AU2018395254B2 AU2018395254A AU2018395254A AU2018395254B2 AU 2018395254 B2 AU2018395254 B2 AU 2018395254B2 AU 2018395254 A AU2018395254 A AU 2018395254A AU 2018395254 A AU2018395254 A AU 2018395254A AU 2018395254 B2 AU2018395254 B2 AU 2018395254B2
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Australia
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buffer
aav
naci
wash
affinity resin
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AU2018395254A
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AU2018395254A1 (en
Inventor
Christian Fiedler
Meinhard Hasslacher
Jadranka KOEHN
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Takeda Pharmaceutical Co Ltd
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Takeda Pharmaceutical Co Ltd
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors
    • 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
    • B01D15/16—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166—Fluid composition conditioning, e.g. gradient
    • 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
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • 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
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective 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
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • 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
    • B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424—Elution mode
    • B01D15/426—Specific type of solvent
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/14011—Parvoviridae
    • C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14141—Use of virus, viral particle or viral elements as a vector
    • C12N2750/14143—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/14011—Parvoviridae
    • C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14151—Methods of production or purification of viral material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/01—DNA viruses
    • G01N2333/075—Adenoviridae

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  • 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)
AU2018395254A 2017-12-29 2018-12-27 Adeno-associated virus purification methods Active AU2018395254B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762611709P 2017-12-29 2017-12-29
US62/611,709 2017-12-29
PCT/US2018/067627 WO2019133677A1 (en) 2017-12-29 2018-12-27 Adeno-associated virus purification methods

Publications (2)

Publication Number Publication Date
AU2018395254A1 AU2018395254A1 (en) 2020-06-25
AU2018395254B2 true AU2018395254B2 (en) 2024-07-25

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AU2018395254A Active AU2018395254B2 (en) 2017-12-29 2018-12-27 Adeno-associated virus purification methods

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

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KR20210032984A (ko) * 2018-07-11 2021-03-25 박스알타 인코퍼레이티드 Aav 조성물
CN114173827B (zh) * 2019-06-28 2025-01-28 武田药品工业株式会社 腺相关病毒纯化方法
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
US20230302381A1 (en) * 2020-08-18 2023-09-28 Sartorius Bia Separations D.O.O. Metal-affinity extraction of host cell dna
AU2021375404A1 (en) * 2020-11-03 2023-06-08 Pfizer Inc. Methods for purification of aav vectors by anion exchange chromatography
EP4251756A1 (en) * 2020-11-24 2023-10-04 Sartorius BIA Separations d.o.o. Improved washing methods for affinity chromatography
IL303959A (en) * 2020-12-23 2023-08-01 Pfizer Methods for purification of aav vectors by affinity chromatography
US20240084268A1 (en) * 2021-01-21 2024-03-14 Asklepios Biopharmaceutical, Inc. Method for purifying recombinant viral particles
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
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
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
WO2023077086A1 (en) * 2021-10-29 2023-05-04 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
MX2024010855A (es) 2022-03-07 2024-09-11 Takeda Pharmaceuticals Co Produccion cromatografica de afinidad de productos clinicos de inmunoglobulina g (igg) humana.
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
KR20260049579A (ko) * 2023-08-01 2026-04-14 메르크 파텐트 게엠베하 개선된 용리 시스템의 음이온 교환 크로마토그래피를 사용한 aav 입자의 연마
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 (3)

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WO2001030983A1 (en) * 1999-10-27 2001-05-03 University College London Method for purifying aav
WO2002012455A1 (en) * 2000-08-07 2002-02-14 Avigen, Inc. LARGE-SCALE RECOMBINANT ADENO-ASSOCIATED VIRUS (rAAV) PRODUCTION AND PURIFICATION
WO2017100676A1 (en) * 2015-12-11 2017-06-15 The Trustees Of The University Of Pennsylvania Scalable purification method for aav8

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SE9902133D0 (sv) 1999-06-06 1999-06-06 Amersham Pharm Biotech Ab A method for surface modification, a novel support matrix and the use of the matrix
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WO2014066471A1 (en) 2012-10-24 2014-05-01 Genzyme Corporation Elution of biomolecules from multi-modal resins using mes and mops as mobile phase modifiers
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EP3054007A1 (en) * 2015-02-09 2016-08-10 Institut National De La Sante Et De La Recherche Medicale (Inserm) Recombinant adeno-associated virus particle purification comprising an immuno-affinity purification step
EP3387138B1 (en) 2015-12-11 2022-01-26 The Trustees Of The University Of Pennsylvania Scalable purification method for aav9
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WO2001030983A1 (en) * 1999-10-27 2001-05-03 University College London Method for purifying aav
WO2002012455A1 (en) * 2000-08-07 2002-02-14 Avigen, Inc. LARGE-SCALE RECOMBINANT ADENO-ASSOCIATED VIRUS (rAAV) PRODUCTION AND PURIFICATION
WO2017100676A1 (en) * 2015-12-11 2017-06-15 The Trustees Of The University Of Pennsylvania Scalable purification method for aav8

Also Published As

Publication number Publication date
JP2021508484A (ja) 2021-03-11
EP3731863A1 (en) 2020-11-04
AU2018395254A1 (en) 2020-06-25
CN111655285B (zh) 2025-02-25
CA3084827A1 (en) 2019-07-04
CN111655285A (zh) 2020-09-11
RU2020124946A (ru) 2022-01-31
IL275533A (en) 2020-08-31
WO2019133677A1 (en) 2019-07-04
MX2020006884A (es) 2020-10-01
JP7299896B2 (ja) 2023-06-28
JP2023089298A (ja) 2023-06-27
JP7531654B2 (ja) 2024-08-09
RU2020124946A3 (enExample) 2022-02-08
US11981934B2 (en) 2024-05-14
KR20200106045A (ko) 2020-09-10
SG11202006232SA (en) 2020-07-29
EP3731863A4 (en) 2021-10-27
BR112020013197A2 (pt) 2021-02-17
IL275533B2 (en) 2025-03-01
BR112020013197A8 (pt) 2022-11-08
IL275533B1 (en) 2024-11-01
US20200332266A1 (en) 2020-10-22

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