JP7539420B2 - アデノ随伴ウイルスの精製方法 - Google Patents

アデノ随伴ウイルスの精製方法 Download PDF

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JP7539420B2
JP7539420B2 JP2021577391A JP2021577391A JP7539420B2 JP 7539420 B2 JP7539420 B2 JP 7539420B2 JP 2021577391 A JP2021577391 A JP 2021577391A JP 2021577391 A JP2021577391 A JP 2021577391A JP 7539420 B2 JP7539420 B2 JP 7539420B2
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buffer
certain embodiments
wash
elution
aav
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JP2022539148A (ja
JP2022539148A5 (enExample
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フィードラー，クリスティアン
シャインデル，マルクス
ハスラヒャー，マインハルト
コーエン，ヤドランカ
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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
    • B01D15/161—Temperature conditioning
    • 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
    • B01D15/20—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
    • 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
    • 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
    • C12N2750/14122—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
    • 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
    • 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
    • C12N2750/14152—Methods of production or purification of viral material relating to complementing cells and packaging systems for producing virus or viral particles

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Organic Chemistry (AREA)
  • Biotechnology (AREA)
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  • Wood Science & Technology (AREA)
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  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Virology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
JP2021577391A 2019-06-28 2020-06-26 アデノ随伴ウイルスの精製方法 Active JP7539420B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962868282P 2019-06-28 2019-06-28
US62/868,282 2019-06-28
PCT/US2020/039971 WO2020264411A1 (en) 2019-06-28 2020-06-26 Adeno-associated virus purification methods

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JP2022539148A JP2022539148A (ja) 2022-09-07
JP2022539148A5 JP2022539148A5 (enExample) 2023-05-25
JP7539420B2 true JP7539420B2 (ja) 2024-08-23

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US (1) US20220267796A1 (enExample)
EP (1) EP3990031A4 (enExample)
JP (1) JP7539420B2 (enExample)
CN (1) CN114173827B (enExample)
TW (1) TWI886135B (enExample)
WO (1) WO2020264411A1 (enExample)

Families Citing this family (12)

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Publication number Priority date Publication date Assignee Title
AR102198A1 (es) 2014-10-09 2017-02-08 Regeneron Pharma Proceso para reducir partículas subvisibles en una formulación farmacéutica
US11020686B2 (en) 2016-08-16 2021-06-01 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
JP7102401B2 (ja) 2016-10-25 2022-07-19 リジェネロン・ファーマシューティカルズ・インコーポレイテッド クロマトグラフィーデータ解析のための方法およびシステム
CA3073935A1 (en) 2017-09-19 2019-03-28 Regeneron Pharmaceuticals, Inc. Methods of reducing particle formation and compositions formed thereby
TWI853823B (zh) 2018-07-02 2024-09-01 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
EA202192422A1 (ru) 2019-03-05 2021-12-09 Ридженерон Фармасьютикалз, Инк. Человеческий сывороточный альбумин в составах
US20250027855A1 (en) * 2022-01-03 2025-01-23 Kerth Corp. Biological kit for separating electronegative low density lipoprotein from specimen, reagent solution and method for separating electronegative low density lipoprotein from specimen
US20230303983A1 (en) * 2022-03-28 2023-09-28 President And Fellows Of Harvard College High efficiency purification of divergent aav serotypes using aavx affinity chromatography
US20250179442A1 (en) * 2022-03-29 2025-06-05 Kaneka Corporation Method of producing adeno-associated virus
CA3247416A1 (en) * 2022-04-08 2023-10-12 Csl Behring Ag Methods of sanitizing and/or regenerating a chromatography medium
KR20260019635A (ko) * 2023-06-09 2026-02-10 사르토리우스 비아이에이 세퍼레이션스 디.오.오. 완전 충전 아데노 관련 바이러스 (aav) 캡시드의 향상된 분리 방법
EP4731755A2 (en) * 2023-06-23 2026-04-29 Ultragenyx Pharmaceutical Inc. Compositions and methods for reducing host cell proteins in recombinant adeno-associated virus preparations

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002503484A (ja) 1998-02-17 2002-02-05 シェーリング コーポレイション ウイルスを含む組成物、およびウイルス調製物を濃縮するための方法
JP2018507707A (ja) 2015-02-09 2018-03-22 インスティチュート ナショナル デ ラ サンテ エ デ ラ ルシェルシュ メディカル （インセルム） 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

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7732129B1 (en) * 1998-12-01 2010-06-08 Crucell Holland B.V. Method for the production and purification of adenoviral vectors
US6593123B1 (en) * 2000-08-07 2003-07-15 Avigen, Inc. Large-scale recombinant adeno-associated virus (rAAV) production and purification
US20040106184A1 (en) * 2002-08-28 2004-06-03 Introgen Therapeutics Inc. Chromatographic methods for adenovirus purification
US20070207461A1 (en) * 2004-02-23 2007-09-06 Crucell Holland B.V. Virus Purification Methods
EP1783138A4 (en) * 2004-07-27 2007-08-22 Genomidea Inc PROCESS FOR PURIFYING A VIRUS ENVELOPE
CN101983238B (zh) * 2008-03-31 2013-06-12 日本烟草产业株式会社 病毒浓缩方法
LT3436051T (lt) * 2016-03-31 2021-11-25 Spark Therapeutics, Inc. Kolonėlėmis pagrįstas visiškai keičiamo masto raav gavimo būdas
EP3731863A4 (en) * 2017-12-29 2021-10-27 Baxalta Incorporated ADENO-ASSOCIATED VIRUS CLEANSING PROCEDURES

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002503484A (ja) 1998-02-17 2002-02-05 シェーリング コーポレイション ウイルスを含む組成物、およびウイルス調製物を濃縮するための方法
JP2018507707A (ja) 2015-02-09 2018-03-22 インスティチュート ナショナル デ ラ サンテ エ デ ラ ルシェルシュ メディカル （インセルム） 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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Mol. Ther. Methods Clin. Dev.，2018年，Vol.9，pp.33-46
Molecular Therapy，2018年，Vol.26, No.5, Suppl.1，p.291, Abstract No.631

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Publication number Publication date
US20220267796A1 (en) 2022-08-25
JP2022539148A (ja) 2022-09-07
TW202115248A (zh) 2021-04-16
CN114173827B (zh) 2025-01-28
EP3990031A4 (en) 2023-08-09
EP3990031A1 (en) 2022-05-04
CN114173827A (zh) 2022-03-11
WO2020264411A1 (en) 2020-12-30
TWI886135B (zh) 2025-06-11

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