KR20200106045A - 아데노-연관 바이러스 정제 방법 - Google Patents

아데노-연관 바이러스 정제 방법 Download PDF

Info

Publication number
KR20200106045A
KR20200106045A KR1020207021627A KR20207021627A KR20200106045A KR 20200106045 A KR20200106045 A KR 20200106045A KR 1020207021627 A KR1020207021627 A KR 1020207021627A KR 20207021627 A KR20207021627 A KR 20207021627A KR 20200106045 A KR20200106045 A KR 20200106045A
Authority
KR
South Korea
Prior art keywords
buffer
elution
aav
affinity resin
nacl
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.)
Ceased
Application number
KR1020207021627A
Other languages
English (en)
Korean (ko)
Inventor
크리스티안 피에들러
마인하르트 하슬라허
자드란카 코엔
Original Assignee
박스알타 인코퍼레이티드
박스앨타 게엠베하
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 박스알타 인코퍼레이티드, 박스앨타 게엠베하 filed Critical 박스알타 인코퍼레이티드
Publication of KR20200106045A publication Critical patent/KR20200106045A/ko
Ceased legal-status Critical Current

Links

Images

Classifications

    • 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)
KR1020207021627A 2017-12-29 2018-12-27 아데노-연관 바이러스 정제 방법 Ceased KR20200106045A (ko)

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
KR20200106045A true KR20200106045A (ko) 2020-09-10

Family

ID=67064154

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020207021627A Ceased KR20200106045A (ko) 2017-12-29 2018-12-27 아데노-연관 바이러스 정제 방법

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=)

Families Citing this family (22)

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

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
HUE028341T2 (en) 2009-06-16 2016-12-28 Genzyme Corp Improved methods for purification of recombinant aav vectors
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
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
WO2017100676A1 (en) 2015-12-11 2017-06-15 The Trustees Of The University Of Pennsylvania Scalable purification method for aav8
EP3387138B1 (en) 2015-12-11 2022-01-26 The Trustees Of The University Of Pennsylvania Scalable purification method for aav9
KR20220100017A (ko) 2019-11-21 2022-07-14 이엠디 밀리포어 코포레이션 친수성 막

Also Published As

Publication number Publication date
MX2020006884A (es) 2020-10-01
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
IL275533B2 (en) 2025-03-01
JP7531654B2 (ja) 2024-08-09
IL275533A (en) 2020-08-31
RU2020124946A3 (https=) 2022-02-08
CN111655285B (zh) 2025-02-25

Similar Documents

Publication Publication Date Title
JP7531654B2 (ja) アデノ随伴ウイルス精製方法
JP7539420B2 (ja) アデノ随伴ウイルスの精製方法
JP7385603B2 (ja) 組換えａａｖ生成のためのアニオン交換クロマトグラフィー
EP3256573B1 (en) Recombinant adeno-associated virus particle purification with multiple-step anion exchange chromatography
AU2018291023A1 (en) AAV vector column purification methods
JP2018507707A (ja) アフィニティー精製工程を含む組換えアデノ随伴ウイルス粒子の精製
ES2965341T3 (es) Métodos de cromatografía de exclusión por tamaño para la caracterización de composiciones de virus adenoasociados recombinantes
WO2024081551A1 (en) Method of purifying full recombinant aav particles
CN120283059A (zh) 纯化aav衣壳的色谱方法
RU2785661C2 (ru) Способы очистки аденоассоциированных вирусов
WO2024252182A1 (en) Cation exchange chromatography for aav capture
RU2772876C2 (ru) Колоночные способы очистки вектора на основе aav

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

N231 Notification of change of applicant
PN2301 Change of applicant

St.27 status event code: A-3-3-R10-R13-asn-PN2301

St.27 status event code: A-3-3-R10-R11-asn-PN2301

A201 Request for examination
E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

B15 Application refused following examination

Free format text: ST27 STATUS EVENT CODE: N-2-6-B10-B15-EXM-PE0601 (AS PROVIDED BY THE NATIONAL OFFICE)

PE0601 Decision on rejection of patent

St.27 status event code: N-2-6-B10-B15-exm-PE0601

R18 Changes to party contact information recorded

Free format text: ST27 STATUS EVENT CODE: A-3-3-R10-R18-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

R18-X000 Changes to party contact information recorded

St.27 status event code: A-3-3-R10-R18-oth-X000

T11 Administrative time limit extension requested

Free format text: ST27 STATUS EVENT CODE: U-3-3-T10-T11-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T13 Administrative time limit extension granted

Free format text: ST27 STATUS EVENT CODE: U-3-3-T10-T13-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

T13-X000 Administrative time limit extension granted

St.27 status event code: U-3-3-T10-T13-oth-X000

R17 Change to representative recorded

Free format text: ST27 STATUS EVENT CODE: A-3-3-R10-R17-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

R17-X000 Change to representative recorded

St.27 status event code: A-3-3-R10-R17-oth-X000

T11 Administrative time limit extension requested

Free format text: ST27 STATUS EVENT CODE: U-3-3-T10-T11-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T13 Administrative time limit extension granted

Free format text: ST27 STATUS EVENT CODE: U-3-3-T10-T13-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

T13-X000 Administrative time limit extension granted

St.27 status event code: U-3-3-T10-T13-oth-X000

E13 Pre-grant limitation requested

Free format text: ST27 STATUS EVENT CODE: A-2-3-E10-E13-LIM-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-NAP-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000