DE69012903D1 - Verfahren zur herstellung und reinigung von hepatitis b-impfstoff. - Google Patents

Verfahren zur herstellung und reinigung von hepatitis b-impfstoff.

Info

Publication number: DE69012903D1
Authority: DE; Germany
Prior art keywords: molecular weight; hepatitis; high molecular; contaminant proteins; particles
Prior art date: 1989-02-07
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

DE69012903T

Other languages

English (en)

Other versions

DE69012903T2 (de

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 (ndgesd Staates

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.)

1989-02-07

Filing date

1990-02-07

Publication date

1994-11-03

1990-02-07 Application filed by Savient Pharmaceuticals Inc filed Critical Savient Pharmaceuticals Inc

1994-11-03 Application granted granted Critical

1994-11-03 Publication of DE69012903D1 publication Critical patent/DE69012903D1/de

1995-05-11 Publication of DE69012903T2 publication Critical patent/DE69012903T2/de

2010-02-08 Anticipated expiration legal-status Critical

Status Expired - Lifetime legal-status Critical Current

Links

238000004140 cleaning Methods 0.000 title 1
SPSXSWRZQFPVTJ-ZQQKUFEYSA-N hepatitis b vaccine Chemical compound C([C@H](NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](N)CCSC)C(=O)N[C@@H](CC1N=CN=C1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)OC(=O)CNC(=O)CNC(=O)[C@H](C)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@@H](N)CCCNC(N)=N)C1=CC=CC=C1 SPSXSWRZQFPVTJ-ZQQKUFEYSA-N 0.000 title 1
229940124736 hepatitis-B vaccine Drugs 0.000 title 1
238000004519 manufacturing process Methods 0.000 title 1
239000013542 high molecular weight contaminant Substances 0.000 abstract 3
239000002245 particle Substances 0.000 abstract 3
108090000623 proteins and genes Proteins 0.000 abstract 3
102000004169 proteins and genes Human genes 0.000 abstract 3
239000000427 antigen Substances 0.000 abstract 2
102000036639 antigens Human genes 0.000 abstract 2
108091007433 antigens Proteins 0.000 abstract 2
239000001963 growth medium Substances 0.000 abstract 2
208000002672 hepatitis B Diseases 0.000 abstract 2
210000004962 mammalian cell Anatomy 0.000 abstract 2
238000000746 purification Methods 0.000 abstract 2
108091003079 Bovine Serum Albumin Proteins 0.000 abstract 1
210000004027 cell Anatomy 0.000 abstract 1
230000010261 cell growth Effects 0.000 abstract 1
239000000356 contaminant Substances 0.000 abstract 1
238000012258 culturing Methods 0.000 abstract 1
239000012894 fetal calf serum Substances 0.000 abstract 1
230000002401 inhibitory effect Effects 0.000 abstract 1
238000000034 method Methods 0.000 abstract 1
210000002966 serum Anatomy 0.000 abstract 1

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)
Biophysics (AREA)
Biomedical Technology (AREA)
Public Health (AREA)
Communicable Diseases (AREA)
Animal Behavior & Ethology (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Oncology (AREA)
Physics & Mathematics (AREA)
Plant Pathology (AREA)
Gastroenterology & Hepatology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Immunology (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)
Micro-Organisms Or Cultivation Processes Thereof (AREA)
Peptides Or Proteins (AREA)

DE69012903T 1989-02-07 1990-02-07 Verfahren zur herstellung und reinigung von hepatitis b-impfstoff. Expired - Lifetime DE69012903T2 (de)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US30777789A	1989-02-07	1989-02-07
PCT/US1990/000747 WO1990010058A2 (en)	1989-02-07	1990-02-07	Method for production and purification of hepatitis b vaccine

Publications (2)

Publication Number	Publication Date
DE69012903D1 true DE69012903D1 (de)	1994-11-03
DE69012903T2 DE69012903T2 (de)	1995-05-11

Family

ID=23191134

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
DE69012903T Expired - Lifetime DE69012903T2 (de)	1989-02-07	1990-02-07	Verfahren zur herstellung und reinigung von hepatitis b-impfstoff.

Country Status (13)

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

Families Citing this family (2)

* 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
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

Family Cites Families (10)

* 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
JPS6078999A (ja) *	1983-10-05	1985-05-04	Chemo Sero Therapeut Res Inst	ＨＢｓ抗原の精製方法
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.
US4742158A (en) *	1986-04-25	1988-05-03	Merck & Co., Inc.	Purification of hepatitis pre-S antigens by polymerized serum albumin affinity binding
IL79740A0 (en) *	1986-08-17	1986-11-30	Yeda Res & Dev	Hepatitis vaccine
WO1988006185A1 (en) *	1987-02-11	1988-08-25	Scripps Clinic And Research Foundation	Retroviral expression vectors and methods for producing hbv antigens
JPS63230639A (ja) *	1987-03-19	1988-09-27	Nippon Chem Res Kk	新規なｂ型肝炎ウイルス表面抗原粒子とその製法
US4883865A (en) *	1987-09-30	1989-11-28	Merck & Co. Inc.	Recovery of pres2+s antigen
EP0328123A1 (de) *	1988-02-09	1989-08-16	Eugene Tech International, Inc.	Pre-S-reiches Hepatitis-B-Oberflächenantigen

1990
- 1990-02-07 IL IL93304A patent/IL93304A/xx not_active IP Right Cessation
- 1990-02-07 CA CA002026570A patent/CA2026570C/en not_active Expired - Lifetime
- 1990-02-07 WO PCT/US1990/000747 patent/WO1990010058A2/en active IP Right Grant
- 1990-02-07 RU SU4831850/13A patent/RU2080876C1/ru active
- 1990-02-07 DK DK90907882.6T patent/DK0408742T3/da active
- 1990-02-07 AT AT90907882T patent/ATE112170T1/de not_active IP Right Cessation
- 1990-02-07 ES ES90907882T patent/ES2061040T3/es not_active Expired - Lifetime
- 1990-02-07 JP JP2507455A patent/JP2825647B2/ja not_active Expired - Lifetime
- 1990-02-07 KR KR1019900702244A patent/KR0148119B1/ko not_active IP Right Cessation
- 1990-02-07 DE DE69012903T patent/DE69012903T2/de not_active Expired - Lifetime
- 1990-02-07 AU AU56485/90A patent/AU632575B2/en not_active Expired
- 1990-02-07 EP EP90907882A patent/EP0408742B1/de not_active Expired - Lifetime
1995
- 1995-11-30 HK HK183395A patent/HK183395A/xx not_active IP Right Cessation

Also Published As

Publication number	Publication date
WO1990010058A2 (en)	1990-09-07
EP0408742A1 (de)	1991-01-23
JP2825647B2 (ja)	1998-11-18
DE69012903T2 (de)	1995-05-11
CA2026570A1 (en)	1991-01-08
ES2061040T3 (es)	1994-12-01
JPH03503847A (ja)	1991-08-29
WO1990010058A3 (en)	1990-11-01
RU2080876C1 (ru)	1997-06-10
IL93304A (en)	1992-09-06
KR910700071A (ko)	1991-03-13
AU5648590A (en)	1990-09-26
ATE112170T1 (de)	1994-10-15
AU632575B2 (en)	1993-01-07
CA2026570C (en)	2000-05-30
KR0148119B1 (ko)	1998-08-17
EP0408742A4 (en)	1992-12-09
EP0408742B1 (de)	1994-09-28
IL93304A0 (en)	1990-11-29
HK183395A (en)	1995-12-08
DK0408742T3 (da)	1995-03-20

Publication	Publication Date	Title
DE69031791D1 (de)	1998-01-22	Verfahren zur HCV-Züchtung in Zell-Linien aus B- oder T-Lymphozyten
DE69740002D1 (de)	2010-11-04	Tierzellen und verfahren für die replikation von influenza viren
DE69334254D1 (de)	2009-02-12	Verfahren zur Zellkultivierung in einer Monoschicht
DE69626022D1 (de)	2003-03-06	Verfahren zur industriellen herstellung eines japanischen enkephalitis impfstoffes, und so erhaltener impfstoff
SE8402861L (sv)	1985-11-29	Rening av biologiskt material
DE602004026051D1 (de)	2010-04-29	Pharmazeutisch verträgliches verfahren zur reinigung intakter bakterienminizellen
ATE77242T1 (de)	1992-07-15	Verfahren zur herstellung eines hochreinen, virussicheren, biologisch aktiven transferrinpraeparates.
DK615288D0 (da)	1988-11-03	Fermenteringsfremgangsmaade
DE3786806D1 (de)	1993-09-09	Reinigung von keuchhustenantigenen.
DE69012579D1 (de)	1994-10-20	Verfahren zur rückgewinnung rekombinanter proteine unter verwendung von flockungsmitteln.
ATE133705T1 (de)	1996-02-15	Verfahren zur biologischen inaktivierung von nukleinsäuren
ATE220714T1 (de)	2002-08-15	Verfahren zur herstellung von proteinen
ES514496A0 (es)	1983-04-16	"un procedimiento de obtencion de poliosidos capsulares inmunogenos".
DE69012903D1 (de)	1994-11-03	Verfahren zur herstellung und reinigung von hepatitis b-impfstoff.
ATE132875T1 (de)	1996-01-15	Verfahren zur herstellung von zellprotein mit anti-hiv-wirkung
ATE312195T1 (de)	2005-12-15	Verfahren zur herstellung von fremden proteinen
SU1691391A1 (ru)	1991-11-15	Способ культивировани фибробластов
ATE81530T1 (de)	1992-10-15	Verfahren zur fermentativen herstellung von laminos\|uren aus alpha-ketocarbonsaeuren.
ATE51026T1 (de)	1990-03-15	Hybridzellen, die ein hepatitis-b-virus-antigen produzieren, aus hepatocyten und errichteten affenzellen, verfahren zur herstellung dieser hybridzellen und verwendung derselben zur herstellung der obenerwaehnten antigens.

Legal Events

Date	Code	Title	Description
1995-10-26	8364	No opposition during term of opposition
2004-04-22	8327	Change in the person/name/address of the patent owner	Owner name: SAVIENT PHARMACEUTICALS, INC. (N.D.GES.D. STAATES