DE10144906B4 - Verfahren zur großtechnischen Herstellung von Impfstoffen - Google Patents

Verfahren zur großtechnischen Herstellung von Impfstoffen Download PDF

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Publication number
DE10144906B4
DE10144906B4 DE10144906A DE10144906A DE10144906B4 DE 10144906 B4 DE10144906 B4 DE 10144906B4 DE 10144906 A DE10144906 A DE 10144906A DE 10144906 A DE10144906 A DE 10144906A DE 10144906 B4 DE10144906 B4 DE 10144906B4
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Germany
Prior art keywords
virus
culture
cells
medium
cell
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.)
Expired - Lifetime
Application number
DE10144906A
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German (de)
English (en)
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DE10144906A1 (de
Inventor
Dr. Gregersen Jens-Peter
Jürgen Vorlop
Christian Frech
Dr. Lübben Holger
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.)
Novartis AG
Original Assignee
Novartis Vaccines and Diagnostics GmbH
Novartis Vaccines and Diagnostics 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
Priority to DE10144906A priority Critical patent/DE10144906B4/de
Application filed by Novartis Vaccines and Diagnostics GmbH, Novartis Vaccines and Diagnostics Inc filed Critical Novartis Vaccines and Diagnostics GmbH
Priority to CA2455189A priority patent/CA2455189C/en
Priority to EP10004227A priority patent/EP2216400A1/de
Priority to AT08018057T priority patent/ATE512213T1/de
Priority to PCT/EP2002/010208 priority patent/WO2003023021A2/de
Priority to DE50214630T priority patent/DE50214630D1/de
Priority to NZ532202A priority patent/NZ532202A/en
Priority to BR0212470-0A priority patent/BR0212470A/pt
Priority to ES02777069T priority patent/ES2351300T3/es
Priority to DK08018057.3T priority patent/DK2011862T3/da
Priority to KR1020047003712A priority patent/KR100999345B1/ko
Priority to EP08018057A priority patent/EP2011862B1/de
Priority to DE122011000005C priority patent/DE122011000005I1/de
Priority to AU2002338667A priority patent/AU2002338667B2/en
Priority to ES08018057T priority patent/ES2367833T3/es
Priority to SI200230924T priority patent/SI1427815T1/sl
Priority to US10/487,707 priority patent/US10329536B2/en
Priority to JP2003527086A priority patent/JP2005532779A/ja
Priority to EP02777069A priority patent/EP1427815B1/de
Priority to AT02777069T priority patent/ATE479742T1/de
Priority to PT08018057T priority patent/PT2011862E/pt
Priority to DK02777069.2T priority patent/DK1427815T3/da
Priority to HK04104991.7A priority patent/HK1062030B/xx
Priority to PT02777069T priority patent/PT1427815E/pt
Publication of DE10144906A1 publication Critical patent/DE10144906A1/de
Priority to JP2008204890A priority patent/JP2008289499A/ja
Priority to AU2008207588A priority patent/AU2008207588B2/en
Priority to JP2010058365A priority patent/JP5264812B2/ja
Priority to CY20101101097T priority patent/CY1110964T1/el
Priority to JP2011158481A priority patent/JP2011212021A/ja
Priority to CY20111100819T priority patent/CY1113241T1/el
Application granted granted Critical
Publication of DE10144906B4 publication Critical patent/DE10144906B4/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
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    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5252—Virus inactivated (killed)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10051—Methods of production or purification of viral material
    • C—CHEMISTRY; METALLURGY
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    • C12N2710/00011—Details
    • C12N2710/16011—Herpesviridae
    • C12N2710/16611—Simplexvirus, e.g. human herpesvirus 1, 2
    • C12N2710/16651—Methods of production or purification of viral material
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    • C12N2710/00011—Details
    • C12N2710/16011—Herpesviridae
    • C12N2710/16711—Varicellovirus, e.g. human herpesvirus 3, Varicella Zoster, pseudorabies
    • C12N2710/16751—Methods of production or purification of viral material
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    • C12N2710/00011—Details
    • C12N2710/24011—Poxviridae
    • C12N2710/24111—Orthopoxvirus, e.g. vaccinia virus, variola
    • C12N2710/24151—Methods of production or purification of viral material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2720/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011—Details
    • C12N2720/12011—Reoviridae
    • C12N2720/12051—Methods of production or purification of viral material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2720/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011—Details
    • C12N2720/12011—Reoviridae
    • C12N2720/12311—Rotavirus, e.g. rotavirus A
    • C12N2720/12351—Methods of production or purification of viral material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16211—Influenzavirus B, i.e. influenza B virus
    • C12N2760/16251—Methods of production or purification of viral material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2760/00011—Details
    • C12N2760/18011—Paramyxoviridae
    • C12N2760/18051—Methods of production or purification of viral material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/18011—Paramyxoviridae
    • C12N2760/18511—Pneumovirus, e.g. human respiratory syncytial virus
    • C12N2760/18551—Methods of production or purification of viral material
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    • C12N2760/00011—Details
    • C12N2760/20011—Rhabdoviridae
    • C12N2760/20111—Lyssavirus, e.g. rabies virus
    • C12N2760/20151—Methods of production or purification of viral material
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    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24151—Methods of production or purification of viral material
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
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  • Virology (AREA)
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  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Communicable Diseases (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
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  • General Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
DE10144906A 2001-09-12 2001-09-12 Verfahren zur großtechnischen Herstellung von Impfstoffen Expired - Lifetime DE10144906B4 (de)

Priority Applications (30)

Application Number Priority Date Filing Date Title
DE10144906A DE10144906B4 (de) 2001-09-12 2001-09-12 Verfahren zur großtechnischen Herstellung von Impfstoffen
JP2003527086A JP2005532779A (ja) 2001-09-12 2002-09-11 Ｍｄｃｋ細胞懸濁培養物において薬物または診断剤の活性成分を生成する方法
AT08018057T ATE512213T1 (de) 2001-09-12 2002-09-11 Verfahren zur herstellung eines aktiven bestandteils eines arznei- oder diagnosemittels im mdck-zell-suspensionskultur
PCT/EP2002/010208 WO2003023021A2 (de) 2001-09-12 2002-09-11 Verfahren zur herstellung eines aktiven bestandteils eines arznei- oder diagnosemittels in mdck-zell-suspensionskultur
DE50214630T DE50214630D1 (de) 2001-09-12 2002-09-11 Verfahren zur grosstechnischen herstellung von impfstoffen
NZ532202A NZ532202A (en) 2001-09-12 2002-09-11 Mandine Derby canine kidney (MDCK) cells producing viruses in cell culture on a commercial scale, particularly suited for the production of drugs, especially vaccines, and/or diagnostic reagents
BR0212470-0A BR0212470A (pt) 2001-09-12 2002-09-11 Métodos para produção de um ingrediente ativo de uma droga ou agente diagnóstico em cultura em suspensão de células mdck
ES02777069T ES2351300T3 (es) 2001-09-12 2002-09-11 Procedimiento para la preparacion a escala industrial de vacunas.
DK08018057.3T DK2011862T3 (da) 2001-09-12 2002-09-11 Fremgangsmåde til fremstilling af en aktiv bestanddel af et medicinsk- eller diagnosemiddel i MDCK-celledyrkningssuspension
KR1020047003712A KR100999345B1 (ko) 2001-09-12 2002-09-11 Ｍｄｃｋ 세포 현탁 배양물 중에서 약물 또는 진단제 활성 성분의 생산 방법
AT02777069T ATE479742T1 (de) 2001-09-12 2002-09-11 Verfahren zur grosstechnischen herstellung von impfstoffen
DE122011000005C DE122011000005I1 (de) 2001-09-12 2002-09-11 Verfahren zur grosstechnischen herstellung von impfstoffen
AU2002338667A AU2002338667B2 (en) 2001-09-12 2002-09-11 Methods for producing an active constituent of a pharmaceutical or a diagnostic agent in an MDCK cell suspension culture
ES08018057T ES2367833T3 (es) 2001-09-12 2002-09-11 Procedimiento para la preparación de un componente activo de un fármaco o agente de diagnóstico en cultivo en suspensión de células mdck.
SI200230924T SI1427815T1 (sl) 2001-09-12 2002-09-11 Postopek za proizvodnjo cepiv v industrijskem merilu
US10/487,707 US10329536B2 (en) 2001-09-12 2002-09-11 Methods for producing an active constituent of a pharmaceutical or a diagnostic agent in an MDCK cell suspension culture
CA2455189A CA2455189C (en) 2001-09-12 2002-09-11 Methods for producing an active constituent of a pharmaceutical or a diagnostic agent in an mdck cell suspension culture
EP10004227A EP2216400A1 (de) 2001-09-12 2002-09-11 Verfahren zur Herstellung eines aktiven Bestandteils eines Arznei- oder Diagnosemittels in MDCK-Zell-Suspensionskultur
EP08018057A EP2011862B1 (de) 2001-09-12 2002-09-11 Verfahren zur Herstellung eines aktiven Bestandteils eines Arznei- oder Diagnosemittels im MDCK-Zell-Suspensionskultur
PT08018057T PT2011862E (pt) 2001-09-12 2002-09-11 Método para produção de um componente activo de um medicamento ou meio de diagnóstico em cultura de suspensão de células mdck
DK02777069.2T DK1427815T3 (da) 2001-09-12 2002-09-11 Fremgangsmåder til industriel produktion af vacciner
HK04104991.7A HK1062030B (en) 2001-09-12 2002-09-11 Methods for the industrial production of vaccines
PT02777069T PT1427815E (pt) 2001-09-12 2002-09-11 Métodos para a produção industrial de vacinas
EP02777069A EP1427815B1 (de) 2001-09-12 2002-09-11 Verfahren zur grosstechnischen herstellung von impfstoffen
JP2008204890A JP2008289499A (ja) 2001-09-12 2008-08-07 Ｍｄｃｋ細胞懸濁培養物において薬物または診断剤の活性成分を生成する方法
AU2008207588A AU2008207588B2 (en) 2001-09-12 2008-08-28 Methods for producing an active constituent of a pharmaceutical or a diagnostic agent in an MDCK cell suspension culture
JP2010058365A JP5264812B2 (ja) 2001-09-12 2010-03-15 Ｍｄｃｋ細胞懸濁培養物において薬物または診断剤の活性成分を生成する方法
CY20101101097T CY1110964T1 (el) 2001-09-12 2010-11-30 Μεθοδος παραγωγης εμβολιων μεγαλης κλιμακας
JP2011158481A JP2011212021A (ja) 2001-09-12 2011-07-19 Ｍｄｃｋ細胞懸濁培養物において薬物または診断剤の活性成分を生成する方法
CY20111100819T CY1113241T1 (el) 2001-09-12 2011-08-26 Μεθοδος για την παραγωγη ενεργου συστατικου ενος φαρμακευτικου ή διαγνωστικου μεσου εντος καλλιεργειας αιωρηματος κυτταρων mdck

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE10144906A DE10144906B4 (de) 2001-09-12 2001-09-12 Verfahren zur großtechnischen Herstellung von Impfstoffen

Publications (2)

Publication Number Publication Date
DE10144906A1 DE10144906A1 (de) 2003-03-27
DE10144906B4 true DE10144906B4 (de) 2013-11-28

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