CA3084827A1 - Adeno-associated virus purification methods - Google Patents

Adeno-associated virus purification methods Download PDF

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Publication number
CA3084827A1
CA3084827A1 CA3084827A CA3084827A CA3084827A1 CA 3084827 A1 CA3084827 A1 CA 3084827A1 CA 3084827 A CA3084827 A CA 3084827A CA 3084827 A CA3084827 A CA 3084827A CA 3084827 A1 CA3084827 A1 CA 3084827A1
Authority
CA
Canada
Prior art keywords
buffer
naci
affinity resin
aav
wash
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
CA3084827A
Other languages
English (en)
French (fr)
Inventor
Christian Fiedler
Meinhard Hasslacher
Jadranka KOEHN
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Baxalta GmbH
Baxalta Inc
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 GmbH, Baxalta Inc filed Critical Baxalta GmbH
Publication of CA3084827A1 publication Critical patent/CA3084827A1/en
Pending legal-status Critical Current

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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

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)
CA3084827A 2017-12-29 2018-12-27 Adeno-associated virus purification methods Pending CA3084827A1 (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 (1)

Publication Number Publication Date
CA3084827A1 true CA3084827A1 (en) 2019-07-04

Family

ID=67064154

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3084827A Pending CA3084827A1 (en) 2017-12-29 2018-12-27 Adeno-associated virus purification methods

Country Status (12)

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)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4543363A (en) 1983-06-15 1985-09-24 Asahi Kasei Kogyo Kabushiki Kaisha Ion exchanger having hydroxyl groups bonded directly to backbone skeleton
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
GB9925432D0 (en) 1999-10-27 1999-12-29 Univ London Virus preparation
US6593123B1 (en) * 2000-08-07 2003-07-15 Avigen, Inc. Large-scale recombinant adeno-associated virus (rAAV) production and purification
KR20180000341A (ko) * 2009-06-16 2018-01-02 젠자임 코포레이션 재조합 ａａｖ 벡터에 대한 개선된 정제 방법
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
CN104232687A (zh) 2014-09-17 2014-12-24 许瑞安 一种重组腺相关病毒rAAV载体的分离纯化方法
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
ES2934848T3 (es) * 2015-12-11 2023-02-27 Univ Pennsylvania Método de purificación escalable para AAV8
WO2021101987A1 (en) 2019-11-21 2021-05-27 Emd Millipore Corporation Hydrophilic membranes

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
AU2018395254B2 (en) 2024-07-25
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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