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WO1990010058A3 - Procede de production et de purification d'un vaccin pour l'hepatite b - Google Patents

Procede de production et de purification d'un vaccin pour l'hepatite b Download PDF

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Publication number
WO1990010058A3
WO1990010058A3 PCT/US1990/000747 US9000747W WO9010058A3 WO 1990010058 A3 WO1990010058 A3 WO 1990010058A3 US 9000747 W US9000747 W US 9000747W WO 9010058 A3 WO9010058 A3 WO 9010058A3
Authority
WO
WIPO (PCT)
Prior art keywords
molecular weight
hepatitis
high molecular
purification
contaminant proteins
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
PCT/US1990/000747
Other languages
English (en)
Other versions
WO1990010058A2 (fr
Inventor
Zeev Even-Chen
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.)
Savient Pharmaceuticals Inc
Original Assignee
Savient Pharmaceuticals 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
Application filed by Savient Pharmaceuticals Inc filed Critical Savient Pharmaceuticals Inc
Priority to DE69012903T priority Critical patent/DE69012903T2/de
Priority to KR1019900702244A priority patent/KR0148119B1/ko
Priority to SU4831850/13A priority patent/RU2080876C1/ru
Priority to CA002026570A priority patent/CA2026570C/fr
Priority to EP90907882A priority patent/EP0408742B1/fr
Publication of WO1990010058A2 publication Critical patent/WO1990010058A2/fr
Publication of WO1990010058A3 publication Critical patent/WO1990010058A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K39/29—Hepatitis virus
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • 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
    • C12N2730/00—Reverse transcribing DNA viruses
    • C12N2730/00011—Details
    • C12N2730/10011—Hepadnaviridae
    • C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10122—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Virology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Communicable Diseases (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

On décrit des procédés permettant de produire des particules purifiées d'antigène d'enveloppe de l'hépatite B (HBsAg) dans des cellules de mammifère, qui consistent à faire la culture de cellules de mammifère produisant lesdites particules dans un milieu de culture auquel on a ajouté un sérum exempt de protéines de contamination à poids moléculaire élevé, et à récupérer ensuite les particules purifiées d'antigène d'enveloppe de l'hépatite B. L'extraction par exemple par préfractionnement des molécules ayant un poids moléculaire supérieur à environ 3 x 105 daltons permet de cultiver des cellules dans un milieu de culture contenant des taux élevés de sérum foetal de veau, d'enlever les protéines de contamination à poids moléculaire élevé qui peuvent avoir un effet d'inhibition sur la croissance des cellules, et de simplifier la purification de HBsAg, étant donné que les protéines de contamination à poids moléculaire élevé, qui sont les principaux contaminants, sont extraites par des procédés de purification.
PCT/US1990/000747 1989-02-07 1990-02-07 Procede de production et de purification d'un vaccin pour l'hepatite b Ceased WO1990010058A2 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
DE69012903T DE69012903T2 (de) 1989-02-07 1990-02-07 Verfahren zur herstellung und reinigung von hepatitis b-impfstoff.
KR1019900702244A KR0148119B1 (ko) 1989-02-07 1990-02-07 B형 간염백신의 제조방법 및 정제법
SU4831850/13A RU2080876C1 (ru) 1989-02-07 1990-02-07 Способ получения очищенных частиц поверхностного антигена гепатита в, очищенная частица поверхностного антигена гепатита в человека и вакцина против гепатита в
CA002026570A CA2026570C (fr) 1989-02-07 1990-02-07 Methode de production et de purification de vaccin contre l'hepatite b
EP90907882A EP0408742B1 (fr) 1989-02-07 1990-02-07 Procede de production et de purification d'un vaccin pour l'hepatite b

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US30777789A 1989-02-07 1989-02-07
US307,777 1989-02-07

Publications (2)

Publication Number Publication Date
WO1990010058A2 WO1990010058A2 (fr) 1990-09-07
WO1990010058A3 true WO1990010058A3 (fr) 1990-11-01

Family

ID=23191134

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1990/000747 Ceased WO1990010058A2 (fr) 1989-02-07 1990-02-07 Procede de production et de purification d'un vaccin pour l'hepatite b

Country Status (13)

Country Link
EP (1) EP0408742B1 (fr)
JP (1) JP2825647B2 (fr)
KR (1) KR0148119B1 (fr)
AT (1) ATE112170T1 (fr)
AU (1) AU632575B2 (fr)
CA (1) CA2026570C (fr)
DE (1) DE69012903T2 (fr)
DK (1) DK0408742T3 (fr)
ES (1) ES2061040T3 (fr)
HK (1) HK183395A (fr)
IL (1) IL93304A (fr)
RU (1) RU2080876C1 (fr)
WO (1) WO1990010058A2 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW570803B (en) * 1997-04-09 2004-01-11 Duphar Int Res Influenza vaccine
RU2216021C2 (ru) * 1997-06-20 2003-11-10 Сиферджен Биосистемз, Инк. Способы ретентатной хроматографии для разделения аналитов в образце
RU2135209C1 (ru) * 1998-07-17 1999-08-27 Акционерное общество закрытого типа НПК "Комбиотех Лтд" Фармацевтическая композиция для иммунопрофилактики вирусного гепатита b
RU2238105C1 (ru) * 2003-03-14 2004-10-20 Закрытое акционерное общество научно-производственная компания "Комбиотех" Рекомбинантная вакцина для профилактики вирусного гепатита в (варианты)
CN103319572B (zh) * 2012-03-20 2015-06-24 北京天坛生物制品股份有限公司 一种乙型肝炎表面抗原的纯化方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4442205A (en) * 1981-09-22 1984-04-10 The United States Of America As Represented By The Department Of Health And Human Services Simian virus recombinant that directs the synthesis of hepatitis B surface antigen
US4612283A (en) * 1983-10-05 1986-09-16 501 Juridical Foundation, The Chemo-Sero-Therapeutic Research Institute Method for purification of HBs antigen
EP0257507A1 (fr) * 1986-08-17 1988-03-02 Yeda Research And Development Ltd. Vaccin de l'hépatite
US4741901A (en) * 1981-12-03 1988-05-03 Genentech, Inc. Preparation of polypeptides in vertebrate cell culture
US4742158A (en) * 1986-04-25 1988-05-03 Merck & Co., Inc. Purification of hepatitis pre-S antigens by polymerized serum albumin affinity binding
WO1988006185A1 (fr) * 1987-02-11 1988-08-25 Scripps Clinic And Research Foundation Vecteurs retroviraux d'expression et procedes de production d'antigenes du virus d'hepatite b
US4883865A (en) * 1987-09-30 1989-11-28 Merck & Co. Inc. Recovery of pres2+s antigen

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI861417A0 (fi) * 1985-04-15 1986-04-01 Endotronics Inc Hepatitis b ytantigen framstaelld med rekombinant-dna-teknik, vaccin, diagnostiskt medel och cellinjer samt foerfaranden foer framstaellning daerav.
EP0328123A1 (fr) * 1988-02-09 1989-08-16 Eugene Tech International, Inc. Antigène de surface de l'hépatite B riche en pré-S-hétérogène

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4442205A (en) * 1981-09-22 1984-04-10 The United States Of America As Represented By The Department Of Health And Human Services Simian virus recombinant that directs the synthesis of hepatitis B surface antigen
US4741901A (en) * 1981-12-03 1988-05-03 Genentech, Inc. Preparation of polypeptides in vertebrate cell culture
US4612283A (en) * 1983-10-05 1986-09-16 501 Juridical Foundation, The Chemo-Sero-Therapeutic Research Institute Method for purification of HBs antigen
US4742158A (en) * 1986-04-25 1988-05-03 Merck & Co., Inc. Purification of hepatitis pre-S antigens by polymerized serum albumin affinity binding
EP0257507A1 (fr) * 1986-08-17 1988-03-02 Yeda Research And Development Ltd. Vaccin de l'hépatite
WO1988006185A1 (fr) * 1987-02-11 1988-08-25 Scripps Clinic And Research Foundation Vecteurs retroviraux d'expression et procedes de production d'antigenes du virus d'hepatite b
US4883865A (en) * 1987-09-30 1989-11-28 Merck & Co. Inc. Recovery of pres2+s antigen

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
BIO/TECHNOLOGY, Published February 1987, Vol. 5, BRUNT, "Hepatitis B Vaccine Makers Multiply", pages 103-104. *
CHEMICAL ABSTRACTS, No. 106:28525f; & EP,A,198 474 (SALSTROM et al.), 22 October 1986. *
DERWENT ABSTRACT, No. 88-312212/44; & JP,A,63 230 639 (27-09-88). *
NATURE, Published 1985, Vol. 315, NEURETH et al., "Hepatitis B Virus Contains Pre-S Gene-Encoded Domains", pages 154-156. *

Also Published As

Publication number Publication date
RU2080876C1 (ru) 1997-06-10
ATE112170T1 (de) 1994-10-15
EP0408742A1 (fr) 1991-01-23
HK183395A (en) 1995-12-08
EP0408742A4 (en) 1992-12-09
DE69012903D1 (de) 1994-11-03
KR910700071A (ko) 1991-03-13
AU632575B2 (en) 1993-01-07
JP2825647B2 (ja) 1998-11-18
KR0148119B1 (ko) 1998-08-17
CA2026570C (fr) 2000-05-30
DE69012903T2 (de) 1995-05-11
IL93304A (en) 1992-09-06
IL93304A0 (en) 1990-11-29
AU5648590A (en) 1990-09-26
ES2061040T3 (es) 1994-12-01
DK0408742T3 (da) 1995-03-20
WO1990010058A2 (fr) 1990-09-07
EP0408742B1 (fr) 1994-09-28
CA2026570A1 (fr) 1991-01-08
JPH03503847A (ja) 1991-08-29

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