AU2014232879B2 - Scalable manufacturing process to produce recombinant lentiviral vectors in serum-free suspension cell culture system - Google Patents

Scalable manufacturing process to produce recombinant lentiviral vectors in serum-free suspension cell culture system Download PDF

Info

Publication number
AU2014232879B2
AU2014232879B2 AU2014232879A AU2014232879A AU2014232879B2 AU 2014232879 B2 AU2014232879 B2 AU 2014232879B2 AU 2014232879 A AU2014232879 A AU 2014232879A AU 2014232879 A AU2014232879 A AU 2014232879A AU 2014232879 B2 AU2014232879 B2 AU 2014232879B2
Authority
AU
Australia
Prior art keywords
rlv
vectors
factor
vector
peg
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.)
Active
Application number
AU2014232879A
Other languages
English (en)
Other versions
AU2014232879A1 (en
Inventor
Guang Qu
John Fraser Wright
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.)
Children's Hospital of Philadelphia
Original Assignee
Children's Hospital of Philadelphia
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 Children's Hospital of Philadelphia filed Critical Children's Hospital of Philadelphia
Publication of AU2014232879A1 publication Critical patent/AU2014232879A1/en
Application granted granted Critical
Publication of AU2014232879B2 publication Critical patent/AU2014232879B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0091—Purification or manufacturing processes for gene therapy compositions
    • 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
    • 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
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/15011—Lentivirus, not HIV, e.g. FIV, SIV
    • C12N2740/15041—Use of virus, viral particle or viral elements as a vector
    • C12N2740/15043—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
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/15011—Lentivirus, not HIV, e.g. FIV, SIV
    • C12N2740/15051—Methods of production or purification of viral material

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Manufacturing & Machinery (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU2014232879A 2013-03-15 2014-03-17 Scalable manufacturing process to produce recombinant lentiviral vectors in serum-free suspension cell culture system Active AU2014232879B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361787818P 2013-03-15 2013-03-15
US61/787,818 2013-03-15
PCT/US2014/030370 WO2014145578A1 (en) 2013-03-15 2014-03-17 Scalable manufacturing process to produce recombinant lentiviral vectors in serum-free suspension cell culture system

Publications (2)

Publication Number Publication Date
AU2014232879A1 AU2014232879A1 (en) 2015-09-24
AU2014232879B2 true AU2014232879B2 (en) 2020-03-05

Family

ID=51538029

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014232879A Active AU2014232879B2 (en) 2013-03-15 2014-03-17 Scalable manufacturing process to produce recombinant lentiviral vectors in serum-free suspension cell culture system

Country Status (16)

Country Link
US (2) US20140323556A1 (enExample)
EP (1) EP2970920B1 (enExample)
JP (1) JP6480910B6 (enExample)
KR (1) KR102200278B1 (enExample)
CN (2) CN105378074A (enExample)
AU (1) AU2014232879B2 (enExample)
BR (1) BR112015022292A2 (enExample)
CA (1) CA2904366C (enExample)
DK (1) DK2970920T3 (enExample)
ES (1) ES2681434T3 (enExample)
IL (1) IL241058B (enExample)
MX (1) MX364690B (enExample)
PT (1) PT2970920T (enExample)
RU (1) RU2709678C2 (enExample)
WO (1) WO2014145578A1 (enExample)
ZA (1) ZA201506478B (enExample)

Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11596652B2 (en) 2015-02-18 2023-03-07 Enlivex Therapeutics R&D Ltd Early apoptotic cells for use in treating sepsis
US11497767B2 (en) 2015-02-18 2022-11-15 Enlivex Therapeutics R&D Ltd Combination immune therapy and cytokine control therapy for cancer treatment
US11512289B2 (en) 2015-02-18 2022-11-29 Enlivex Therapeutics Rdo Ltd Combination immune therapy and cytokine control therapy for cancer treatment
US11000548B2 (en) 2015-02-18 2021-05-11 Enlivex Therapeutics Ltd Combination immune therapy and cytokine control therapy for cancer treatment
US11304976B2 (en) 2015-02-18 2022-04-19 Enlivex Therapeutics Ltd Combination immune therapy and cytokine control therapy for cancer treatment
US11318163B2 (en) 2015-02-18 2022-05-03 Enlivex Therapeutics Ltd Combination immune therapy and cytokine control therapy for cancer treatment
TWI547782B (zh) * 2015-03-16 2016-09-01 智易科技股份有限公司 可擴充式製程系統與實現該系統的方法
JP6803339B2 (ja) 2015-04-21 2020-12-23 エンリヴェックス セラピューティクス リミテッド 治療用のプールされた血液アポトーシス細胞調製物及びそれらの使用
EP3384015A4 (en) * 2015-12-01 2019-05-29 Spark Therapeutics, Inc. SCALABLE PROCESS FOR THE PREPARATION OF A RECOMBINANT ADENO ASSOCIATED VIRAL VECTOR IN A SERUM-FREE SUSPENSION CELL CULTURE SYSTEM SUITABLE FOR THE CLINICAL APPLICATION
CN107043784A (zh) * 2016-02-05 2017-08-15 上海吉凯基因化学技术有限公司 一种慢病毒载体的制备方法
JP6884155B2 (ja) 2016-02-18 2021-06-09 エンリヴェックス セラピューティクス リミテッド 癌治療のための併用免疫療法及びサイトカイン制御療法
WO2017173043A1 (en) * 2016-03-30 2017-10-05 Spark Therapeutics, Inc. Cell line for recombinant protein and/or viral vector production
EP3442688A4 (en) 2016-04-12 2019-11-20 Artemis Biosystems, Inc. FILTRATION SYSTEMS FOR INFUSION
CN106497882A (zh) * 2016-10-29 2017-03-15 复旦大学 同时过表达R‑spondin1和Noggin的细胞株及其构建方法和应用
ES2975182T3 (es) * 2017-03-06 2024-07-03 Guangzhou Realbenefitspot Pharmaceutical Co Ltd Métodos de producción y caracterización de vacunas víricas y composición de vacuna vírica
EP3420076B1 (en) 2017-03-06 2024-02-21 Guangzhou Realbenefitspot Pharmaceutical Co., Ltd. Methods of producing and characterizing virus vaccine and virus vaccine composition
CN109251939A (zh) * 2017-07-14 2019-01-22 孙搏 Il-17g-197a慢病毒表达载体、其构建方法及慢病毒的包装测定方法
WO2019147036A1 (ko) * 2018-01-24 2019-08-01 주식회사 에스엘바이젠 뇌유래-신경영양인자를 발현하는 중간엽줄기세포 및 이의 용도
CN110317832B (zh) * 2018-03-28 2022-07-05 西比曼生物科技（香港）有限公司 Gmp级规模化制备重组慢病毒载体的纯化制剂的方法
CN111763238B (zh) * 2019-04-02 2022-07-29 普莱柯生物工程股份有限公司 一种蛋白抗原的纯化方法、制备的蛋白抗原及其应用
ES2965341T3 (es) 2019-04-11 2024-04-12 Regenxbio Inc Métodos de cromatografía de exclusión por tamaño para la caracterización de composiciones de virus adenoasociados recombinantes
CN110054678B (zh) * 2019-05-16 2023-04-18 中国医学科学院血液病医院（血液学研究所） 一种膜结合型mFLT3LG蛋白及其应用
AU2020325705B2 (en) * 2019-08-05 2026-02-05 Sartorius Polyplus Compositions for transfecting a nucleic acid molecule into a cell comprising heterocyclic compounds grafted to a cationic polymer, and their applications
KR20220047635A (ko) 2019-08-23 2022-04-18 론자 워커스빌 아이엔씨. 렌티바이러스 벡터의 생산을 위한 방법 및 작제물
CN110894494B (zh) * 2019-11-22 2022-09-27 广西梧州制药（集团）股份有限公司 一种大规模高密度悬浮培养293细胞高产腺病毒的方法
CN110938654A (zh) * 2019-12-11 2020-03-31 和元生物技术（上海）股份有限公司 一种细胞转染试剂及其应用
CN113122501B (zh) * 2019-12-30 2023-06-16 重庆精准生物技术有限公司 适合大规模临床级病毒载体制备的培养基及其应用
CA3194520A1 (en) * 2020-06-11 2021-12-16 2Seventy Bio, Inc. Methods for manufacturing viral vectors
CA3188923A1 (en) * 2020-08-13 2022-02-17 Michael Sean BURNHAM Methods for producing clinical-grade lentiviral vector
CN112746076B (zh) * 2020-12-28 2023-05-12 中吉智药(南京)生物技术有限公司 一种密码子优化的col7a1基因及慢病毒和应用
WO2022143623A1 (zh) * 2020-12-29 2022-07-07 江苏金斯瑞蓬勃生物科技有限公司 高分散性的hek293t细胞株及其筛选方法
AR125468A1 (es) * 2021-04-27 2023-07-19 Novartis Ag Sistema de producción de vectores virales
EP4373951A1 (en) * 2021-07-19 2024-05-29 2seventy bio, Inc. Vector manufacturing processes
CN113980916B (zh) * 2021-09-27 2024-11-05 湖南丰晖生物科技有限公司 一种慢病毒的纯化方法
US20240425880A1 (en) * 2021-10-12 2024-12-26 Jiangsu Genscript Probio Biotech Co., Ltd. Hek293 cell line adapted to serum-free suspension culture and use thereof
CN114990077A (zh) * 2022-08-01 2022-09-02 深圳市先康达生命科学有限公司 一种慢病毒包装与纯化方法
CN116240241A (zh) * 2022-12-30 2023-06-09 上海本导基因技术有限公司 重组慢病毒载体的纯化制备方法
IN202321021121A (enExample) * 2023-03-24 2024-04-19
EP4694993A1 (en) * 2023-04-12 2026-02-18 Cytiva BioProcess R&D AB A chromatography system, use thereof, and a method for separating enveloped or membranous biological particles
CN122012416A (zh) * 2026-04-14 2026-05-12 山东丽山生物科技有限公司 一种提高慢病毒滴度的方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130052165A1 (en) * 2010-01-12 2013-02-28 Livnat Bangio Methods of Producing Adenovirus Vectors and Viral Preparations Generated Thereby

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5869445A (en) * 1993-03-17 1999-02-09 University Of Washington Methods for eliciting or enhancing reactivity to HER-2/neu protein
US20030157070A1 (en) * 1994-12-30 2003-08-21 Jolly Douglas J. High efficiency ex vivo transduction of cells by high titer recombinant retroviral preparations
US6544769B1 (en) * 1996-12-13 2003-04-08 Schering Corporation Compostions comprising viruses and methods for concentrating virus preparations
US6207455B1 (en) 1997-05-01 2001-03-27 Lung-Ji Chang Lentiviral vectors
US5994136A (en) 1997-12-12 1999-11-30 Cell Genesys, Inc. Method and means for producing high titer, safe, recombinant lentivirus vectors
US7575924B2 (en) * 2000-11-13 2009-08-18 Research Development Foundation Methods and compositions relating to improved lentiviral vectors and their applications
WO2003039459A2 (en) * 2001-11-05 2003-05-15 Genvec, Inc. Viral vector production methods and compositions
DE60327069D1 (de) * 2002-04-30 2009-05-20 Oncolytics Biotech Inc Verbesserte reinigungsmethode für viren
AU2003272868A1 (en) * 2003-10-15 2005-04-27 Agtc Gene Technology Company Ltd. Method for large-scale production, isolation, purification and the uses of multi-type recombinant adeno-associated virus vectors
WO2007004947A1 (en) * 2005-07-06 2007-01-11 Ge Healthcare Bio-Sciences Ab Method of preparing a separation matrix
WO2008148304A1 (en) * 2007-05-31 2008-12-11 Xiamen University Rna interference target for treating aids
EP2012122A1 (en) * 2007-07-06 2009-01-07 Medigene AG Mutated parvovirus structural proteins as vaccines
WO2009153563A1 (en) * 2008-06-18 2009-12-23 Oxford Biomedica (Uk) Limited Virus purification
CN102216450B (zh) * 2008-09-24 2014-05-14 米迪缪尼有限公司 培养细胞、增殖和纯化病毒的方法
JP5956331B2 (ja) 2009-06-16 2016-07-27 ジェンザイム・コーポレーション 組換えａａｖベクターの改良された精製方法
WO2011097447A2 (en) * 2010-02-04 2011-08-11 Neurologix, Inc. Production of recombinant virus

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130052165A1 (en) * 2010-01-12 2013-02-28 Livnat Bangio Methods of Producing Adenovirus Vectors and Viral Preparations Generated Thereby

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ZHOU ET AL., "PEG-modulated column chromatography for purification of recombinant adeno- associated virus serotype 9.", J VIROL METHODS, (2011-04), vol. 173, no. 1, pages 99 - 107 *

Also Published As

Publication number Publication date
JP6480910B6 (ja) 2019-04-03
RU2709678C2 (ru) 2019-12-19
RU2015144057A (ru) 2017-04-27
MX2015012450A (es) 2016-04-25
EP2970920A1 (en) 2016-01-20
CN118256453A (zh) 2024-06-28
WO2014145578A1 (en) 2014-09-18
CA2904366C (en) 2023-07-04
AU2014232879A1 (en) 2015-09-24
US10994028B2 (en) 2021-05-04
BR112015022292A2 (pt) 2017-07-18
IL241058B (en) 2020-05-31
KR102200278B1 (ko) 2021-01-07
CN105378074A (zh) 2016-03-02
MX364690B (es) 2019-05-06
JP2016512700A (ja) 2016-05-09
US20140323556A1 (en) 2014-10-30
IL241058A0 (en) 2015-11-30
DK2970920T3 (en) 2018-08-06
EP2970920A4 (en) 2016-09-14
HK1219978A1 (en) 2017-04-21
US20170368201A1 (en) 2017-12-28
EP2970920B1 (en) 2018-04-25
KR20160024841A (ko) 2016-03-07
CA2904366A1 (en) 2014-09-18
JP6480910B2 (ja) 2019-03-13
PT2970920T (pt) 2018-07-30
ES2681434T3 (es) 2018-09-13
ZA201506478B (en) 2021-09-29

Similar Documents

Publication Publication Date Title
US10994028B2 (en) Scalable manufacturing process to produce recombinant lentiviral vectors in serum-free suspension cell culture system
CN105579581A (zh) 具有优化的a凸出物的重组载体
EP4273236A1 (en) Hek293t cell strain having high dispersibility and screening method therefor
CA3180217A1 (en) Nucleic acid constructs for protein manufacture
US11807865B2 (en) Large commercial scale lentiviral vector production system and vectors produced thereby
JP2025020287A (ja) タンパク質製造用ベクター
HK1219978B (en) Scalable manufacturing process to produce recombinant lentiviral vectors in serum-free suspension cell culture system
RU2844388C1 (ru) Линии клеток с множественными акцепторными сайтами для встраивания генов
CA2858980C (en) Large commercial scale lentiviral vector production system and vectors produced thereby
HK1203360B (en) Large commercial scale lentiviral vector production system and vectors produced thereby

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)