BR112015022292A2 - processo de fabricação escalonável para produzir vetores lentivirais recombinantes em um sistema de cultura celular em suspensão sem soro - Google Patents

processo de fabricação escalonável para produzir vetores lentivirais recombinantes em um sistema de cultura celular em suspensão sem soro

Info

Publication number
BR112015022292A2
BR112015022292A2 BR112015022292A BR112015022292A BR112015022292A2 BR 112015022292 A2 BR112015022292 A2 BR 112015022292A2 BR 112015022292 A BR112015022292 A BR 112015022292A BR 112015022292 A BR112015022292 A BR 112015022292A BR 112015022292 A2 BR112015022292 A2 BR 112015022292A2
Authority
BR
Brazil
Prior art keywords
manufacturing process
cell culture
culture system
serum free
lentiviral vectors
Prior art date
Application number
BR112015022292A
Other languages
English (en)
Inventor
Qu Guang
Fraser Wright John
Original Assignee
Childrens Hospital 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 Childrens Hospital Philadelphia filed Critical Childrens Hospital Philadelphia
Publication of BR112015022292A2 publication Critical patent/BR112015022292A2/pt

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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)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)

Abstract

resumo patente de invenção: "processo de fabricação escalonável para produzir vetores lentivirais recombinantes em um sistema de cultura celular em suspensão sem soro". são fornecidos métodos para a preparação de formulações de vetor rlv altamente purificado em uma escala necessária para atingir a demanda antecipada para a terapia de gene.
BR112015022292A 2013-03-15 2014-03-17 processo de fabricação escalonável para produzir vetores lentivirais recombinantes em um sistema de cultura celular em suspensão sem soro BR112015022292A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361787818P 2013-03-15 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 (1)

Publication Number Publication Date
BR112015022292A2 true BR112015022292A2 (pt) 2017-07-18

Family

ID=51538029

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015022292A BR112015022292A2 (pt) 2013-03-15 2014-03-17 processo de fabricação escalonável para produzir vetores lentivirais recombinantes em um sistema de cultura celular em suspensão sem soro

Country Status (17)

Country Link
US (2) US20140323556A1 (pt)
EP (1) EP2970920B1 (pt)
JP (1) JP6480910B6 (pt)
KR (1) KR102200278B1 (pt)
CN (1) CN105378074A (pt)
AU (1) AU2014232879B2 (pt)
BR (1) BR112015022292A2 (pt)
CA (1) CA2904366C (pt)
DK (1) DK2970920T3 (pt)
ES (1) ES2681434T3 (pt)
HK (1) HK1219978A1 (pt)
IL (1) IL241058B (pt)
MX (1) MX364690B (pt)
PT (1) PT2970920T (pt)
RU (1) RU2709678C2 (pt)
WO (1) WO2014145578A1 (pt)
ZA (1) ZA201506478B (pt)

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US11000548B2 (en) 2015-02-18 2021-05-11 Enlivex Therapeutics Ltd Combination immune therapy and cytokine control therapy for cancer treatment
AU2016221305B2 (en) 2015-02-18 2021-05-27 Enlivex Therapeutics Rdo Ltd Combination immune therapy and cytokine control therapy for cancer treatment
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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
CA3014885A1 (en) 2016-02-18 2017-08-24 Enlivex Therapeutics Ltd. Combination immune therapy and cytokine control therapy for cancer treatment
CN109563496B (zh) * 2016-03-30 2023-08-29 星火治疗有限公司 用于重组蛋白和/或病毒载体生产的细胞系
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EP4382183A2 (en) 2017-03-06 2024-06-12 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
US20210155663A1 (en) * 2018-01-24 2021-05-27 Slbigen Inc. Mesenchymal stem cells expressing brain-derived neurotrophic factor and use thereof
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
WO2020210600A1 (en) * 2019-04-11 2020-10-15 Regenxbio Inc. Methods of size exclusion chromatography for the characterization of recombinant adeno-associated virus compositions
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
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
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
JP2024504914A (ja) * 2020-12-29 2024-02-02 江▲蘇▼金斯瑞蓬勃生物科技有限公司 高分散性ｈｅｋ２９３ｔ細胞株及びそのスクリーニング方法
KR20240035852A (ko) * 2021-07-19 2024-03-18 2세븐티 바이오, 인코포레이티드 벡터 제조 프로세스
CN113980916A (zh) * 2021-09-27 2022-01-28 湖南丰晖生物科技有限公司 一种慢病毒的纯化方法
WO2023061409A1 (zh) * 2021-10-12 2023-04-20 江苏金斯瑞蓬勃生物科技有限公司 适应无血清悬浮培养的hek293细胞株及其应用
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

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Also Published As

Publication number Publication date
PT2970920T (pt) 2018-07-30
HK1219978A1 (zh) 2017-04-21
EP2970920A4 (en) 2016-09-14
KR20160024841A (ko) 2016-03-07
JP6480910B6 (ja) 2019-04-03
CA2904366A1 (en) 2014-09-18
JP6480910B2 (ja) 2019-03-13
WO2014145578A1 (en) 2014-09-18
IL241058B (en) 2020-05-31
CA2904366C (en) 2023-07-04
US20170368201A1 (en) 2017-12-28
KR102200278B1 (ko) 2021-01-07
RU2015144057A (ru) 2017-04-27
IL241058A0 (en) 2015-11-30
RU2709678C2 (ru) 2019-12-19
ES2681434T3 (es) 2018-09-13
JP2016512700A (ja) 2016-05-09
MX364690B (es) 2019-05-06
AU2014232879A1 (en) 2015-09-24
AU2014232879B2 (en) 2020-03-05
MX2015012450A (es) 2016-04-25
ZA201506478B (en) 2021-09-29
US10994028B2 (en) 2021-05-04
DK2970920T3 (en) 2018-08-06
EP2970920A1 (en) 2016-01-20
CN105378074A (zh) 2016-03-02
EP2970920B1 (en) 2018-04-25
US20140323556A1 (en) 2014-10-30

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B12B Appeal against refusal [chapter 12.2 patent gazette]