WO2002005846A1 - Vaccin a combinaison quadrivalente renfermant les anatoxines diphterique et tetanique, l'antigene de surface de la coqueluche et de l'hepatite b et son procede de preparation - Google Patents

Vaccin a combinaison quadrivalente renfermant les anatoxines diphterique et tetanique, l'antigene de surface de la coqueluche et de l'hepatite b et son procede de preparation Download PDF

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Publication number
WO2002005846A1
WO2002005846A1 PCT/KR2001/001153 KR0101153W WO0205846A1 WO 2002005846 A1 WO2002005846 A1 WO 2002005846A1 KR 0101153 W KR0101153 W KR 0101153W WO 0205846 A1 WO0205846 A1 WO 0205846A1
Authority
WO
WIPO (PCT)
Prior art keywords
combination vaccine
dtwph
concentration
range
toxoid
Prior art date
Application number
PCT/KR2001/001153
Other languages
English (en)
Inventor
Cheon-Soon Bae
Gwan-Yeul Lim
Kyung-Nam Park
Hong-Joo Kim
Dal-Ho Um
Jong-Soo Kim
Original Assignee
Green Cross Vaccine Co., Ltd.
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=19676257&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2002005846(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Green Cross Vaccine Co., Ltd. filed Critical Green Cross Vaccine Co., Ltd.
Priority to AU2001269569A priority Critical patent/AU2001269569A1/en
Publication of WO2002005846A1 publication Critical patent/WO2002005846A1/fr

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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
    • 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
    • A61K39/292—Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • 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
    • A61K2039/70—Multivalent vaccine
    • 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
    • A61K39/0016—Combination vaccines based on diphtheria-tetanus-pertussis
    • 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
    • C12N2730/10134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Definitions

  • the present invention relates to a quadrivalent combination vaccine
  • DTwPH combination vaccine including diphtheria toxoid, tetanus
  • HBsAg Hepatitis B surface antigen
  • Hepatitis B infections also can be prevented through immunization so that
  • DTaPH combination vaccine product
  • diphtheria toxoid, tetanus toxoid, acellular pertussis and HBsAg has become
  • combination vaccine include aggregation of individual vaccine solutions and vaccine
  • adheresion refers to the binding of DTwPH combination vaccine particles to the
  • the aggregation in the DTwPH combination vaccine occurs by electrostatic attraction between individual vaccine adsorbed solutions and pertussis bacteria and,
  • the DTwPH combination vaccine has a problem of increasing toxicity due
  • the present invention provides a new quadrivalent DTwPH combination
  • vaccine including diphtheria toxoid, tetanus toxoid, whole cell pertussis, and HBsAg,
  • diphtheria toxoid and tetanus toxoid are adsorbed onto aluminum phosphate
  • AlPO 4 aluminum hydroxide
  • the present invention also provides a preparation method of DTwPH
  • combination vaccine comprising (a) adjusting pH of diphtheria toxoid adsorbed
  • the present invention also provides a combination vaccine storage method
  • the gelatin is in the range of 0.1-0.7 w/v%.
  • a diphtheria toxoid stock solution used in the present invention is prepared
  • culture supernatent is filtered, precipitated, and purified after detoxification with
  • diphtheria toxoid stock solution formalin to obtain a suitable diphtheria toxoid stock solution.
  • toxoid stock solutions can be obtained by using strains or methods other than
  • a tetanus toxoid stock solution is prepared by culturing Clostridium tetani
  • Suitable diphtheria toxoid stock solutions can be obtained by using strains or
  • a pertussis stock solution is prepared by culturing Bordetella pertussis.
  • Suitable pertussis stock solutions can be obtained by using strains or
  • HBsAg is extracted through homogenization from a recombinant yeast
  • the HbsAg from recombinant yeast is subjected to a series of separation
  • HBsAg stock solution Suitable HBsAgs can be obtained by using methods other than described above and
  • HbsAgs from plasma can be also used.
  • Suitable adsorbing agents used in the present invention include aluminum
  • phosphate gels can be purchased or prepared by known methods.
  • a silicon-coated bottle used for storage of combination vaccines in the
  • present invention is manufactured by soaking a glass bottle in a 1 :40 dilute solution
  • silicon-coated bottles can be used.
  • the DTwPH combination vaccine according to the present invention is
  • diphtheria toxoid stock and tetanus toxoid stock solutions are adsorbed onto
  • vaccine according to the present invention are 20-50 Lf/mL for diphtheria toxoid, 4- 20 Lf/mL for tetanus toxoid, 10-24 OU/mL for pertussis, and 10-30 ⁇ g/r ⁇ L for
  • HBsAg concentration of aluminum hydroxide gel.
  • concentration of aluminum hydroxide gel is in the range of 15-35
  • Total aluminum gel concentration is in the range of 550-1000 /zgAl/mL.
  • concentration mean the concentration of Al in aluminum gel.
  • FIG. 1 is a lOOX-magnified photograph showing the degree of aggregation of
  • concentration of aluminum hydroxide gel is considered to be a significant factor.
  • FIG. 1(a) Aluminum hydroxide gel and pertussis bacteria start to aggregate at
  • the concentration of aluminum hydroxide gel no less than 35 gAl/mL
  • hydroxide gel no less than 200 jUgAl/mL, as shown in FIG. 1(b).
  • is adsorbed is preferably in the range of 15-35 / gAl/mL based on the final
  • the diphtheria toxoid adsorbed solution has zero charge or negative charges
  • pertussius stock solution and the diphtheria toxoid adsorbed solution are mixed after
  • the final DTwPH combination vaccine composition has a pH of 6.5-
  • a high-viscosity material such as gelatin in an amount of 0.1-0.7 w/v% to common combination vaccines or to the
  • the storage stability means that the
  • combination vaccine is kept in a white suspension without vaccine aggregation and
  • FIG. 1 is a lOOX-magnified photograph showing the degree of aggregation
  • FIG. 2 is a Western blot photograph showing the adsorption degree of
  • FIG. 3 is a lOOX-magnified photograph taken by an optical microscope
  • a diphtheria toxoid stock solution used in the present invention was prepared
  • a tetanus toxoid stock solution was prepared by culturing Clostridium tetani
  • a pertussis stock solution was prepared by culturing Bordetella pertussis.
  • the resulting culture solution was centrifuged.
  • the obtained pertussis pellet was
  • HBsAg was prepared by culturing recombinant Hansenula polymorpha.
  • the resultant culture was subjected to homogenization for cell extraction and then
  • the concentration of diphtheria can be appropriately adjusted.
  • the concentration of diphtheria can be appropriately adjusted.
  • toxoid solution was adjusted to be about 280 Lf/mL, and the concentration of tetanus toxoid solution was adjusted to be about 50 Lf/ml.
  • concentration of tetanus toxoid solution was adjusted to be about 50 Lf/ml.
  • Lane 1 is for a molecular weight marker
  • Lanes 2, 3, and 4 for a molecular weight marker
  • diphtheria solutions of 0.025 Lf/mL, 0.05 Lf/mL, and 0.10 Lf/mL, respectively, and
  • diphtheria toxoid and tetanus toxoid adsorbed solutions were stored in a cold
  • HBsAg was adsorbed onto aluminum hydroxide
  • diphtheria toxoid adsorbed solution was mixed with the tetanus
  • concentration of the respective stock solutions can be any concentration of the respective stock solutions.
  • composition had the composition shown in Table 1 at pH of 7.1.
  • Ab GMT means the geometric mean of
  • mice were immunized
  • Example 1 having the same antigen composition as in Example 1 (40 Lf/mL diphtheria toxoid,
  • the potency against HBsAg was equivalent to or greater than a reference (used as a standard in
  • Example 7 was portioned into a silicon-coated glass bottle (3mL) and a non-coated
  • gelatin to the DTwPH combination vaccine composition, or by using a silicon-coated
  • the immunogenicity of HBsAg can be maintained in the DTwPH
  • type b (Hib) vaccine or inactivated Polio vaccine can be added in the preparation of
  • the DTwPH combination vaccine or can be mixed with the same immediately before injection for simultaneous immunization.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Selon cette invention, un vaccin à combinaison quadrivalente (DTwPH) comprend des anatoxines diphtériques, des anatoxines tétaniques, pertussis à cellules entières et HbsAg. L'invention porte sur un procédé de préparation de ce vaccin. Dans la préparation du vaccin à combinaison DTwPH, les anatoxines diphtériques et les anatoxines tétaniques sont adsorbées sur le gel d'hydroxyde d'aluminium (Al(OH)3). Le vaccin à combinaison DTwPH est ajusté de façon à avoir un pH final compris entre 6,5 et 7,5, les concentrations de substituants étant également ajustées à la concentration du gel d'hydroxyde d'aluminium comprise entre 15 et 35 νgAl/mL.
PCT/KR2001/001153 2000-07-05 2001-07-05 Vaccin a combinaison quadrivalente renfermant les anatoxines diphterique et tetanique, l'antigene de surface de la coqueluche et de l'hepatite b et son procede de preparation WO2002005846A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001269569A AU2001269569A1 (en) 2000-07-05 2001-07-05 Quadrivalent combination vaccine including diphtheria toxoid, tetanus toxoid, whole cell pertussis and hepatitis surface antigen, and preparation method thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2000-0038164A KR100385711B1 (ko) 2000-07-05 2000-07-05 디프테리아, 파상풍 톡소이드와 백일해균 및ｂ형간염표면항원을 포함한 4가 혼합백신 및 그 제조방법
KR2000/38164 2000-07-05

Publications (1)

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WO2002005846A1 true WO2002005846A1 (fr) 2002-01-24

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ID=19676257

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PCT/KR2001/001153 WO2002005846A1 (fr) 2000-07-05 2001-07-05 Vaccin a combinaison quadrivalente renfermant les anatoxines diphterique et tetanique, l'antigene de surface de la coqueluche et de l'hepatite b et son procede de preparation

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Country Link
KR (1) KR100385711B1 (fr)
CN (1) CN1211121C (fr)
AU (1) AU2001269569A1 (fr)
WO (1) WO2002005846A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0835663A2 (fr) 1992-05-23 1998-04-15 SMITHKLINE BEECHAM BIOLOGICALS s.a. Vaccins combinés contenant des antigènes de surface du virus de l'Hépatite B et d'autres antigènes
KR100385711B1 (ko) * 2000-07-05 2003-05-27 녹십자백신 주식회사 디프테리아, 파상풍 톡소이드와 백일해균 및ｂ형간염표면항원을 포함한 4가 혼합백신 및 그 제조방법
WO2007127665A2 (fr) * 2006-04-26 2007-11-08 Wyeth Nouvelles formulations stabilisant et inhibant la précipitation de compositions immunogènes
EP2206515A1 (fr) 2005-03-17 2010-07-14 Novartis Vaccines and Diagnostics S.r.l. Vaccins combinés à antigènes de coqueluche à cellules entières
KR101058978B1 (ko) * 2002-11-01 2011-08-23 글락소스미스클라인 바이오로지칼즈 에스.에이. 면역원성 조성물
EP2529750A1 (fr) 2008-10-24 2012-12-05 Panacea Biotec Ltd. Combination vaccinale contre la coqueluche (vaccin cellulaire entier)
EP2629792A1 (fr) * 2010-10-18 2013-08-28 Sanofi Pasteur Procédé de stockage d'un vaccin comprenant un adjuvant à base d'aluminium
US9095567B2 (en) 2010-06-04 2015-08-04 Wyeth Llc Vaccine formulations

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104487086B (zh) * 2012-07-07 2019-08-30 巴拉特生物技术国际有限公司 无动物源的不含酒精的疫苗组合物及其制备方法
CN104341499B (zh) * 2014-11-06 2017-05-24 遵义医学院 抗麻疹与百白破四价卵黄抗体制剂的制备工艺

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6434925A (en) * 1987-04-24 1989-02-06 Univ Osaka Method for cultivating bordetella pertussis, pertussis toxoid and mixed vaccine thereof
WO1998019072A1 (fr) * 1996-10-25 1998-05-07 Seiko Epson Corporation Roulement et moteur
WO1999048525A1 (fr) * 1998-03-25 1999-09-30 Smithkline Beecham Biologicals S.A. Composition de vaccin contre hib/dtpa et ses methodes de preparation

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DE2322057A1 (de) * 1973-05-02 1974-11-21 Porsche Ag Vorrichtung zum katalytischen nachverbrennen von abgasen einer mehrzylindrigen brennkraftmaschine
KR920009729A (ko) * 1990-11-26 1992-06-25 전금자 원적외선이 발생하는 도자기 제조방법
AU2088992A (en) * 1992-05-05 1993-11-11 Research Foundation For Microbial Diseases Of Osaka University, The Stabilized live vaccine
EP0835663B1 (fr) * 1992-05-23 2009-09-30 GlaxoSmithKline Biologicals S.A. Vaccins combinés contenant des antigènes de surface du virus de l'Hépatite B et d'autres antigènes
RU2130778C1 (ru) * 1998-07-31 1999-05-27 Акционерное общество закрытого типа НПК "Комбиотех Лтд" Комбинированная вакцина для иммунопрофилактики вирусного гепатита в, столбняка, дифтерии и коклюша
KR100385711B1 (ko) * 2000-07-05 2003-05-27 녹십자백신 주식회사 디프테리아, 파상풍 톡소이드와 백일해균 및ｂ형간염표면항원을 포함한 4가 혼합백신 및 그 제조방법

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6434925A (en) * 1987-04-24 1989-02-06 Univ Osaka Method for cultivating bordetella pertussis, pertussis toxoid and mixed vaccine thereof
WO1998019072A1 (fr) * 1996-10-25 1998-05-07 Seiko Epson Corporation Roulement et moteur
WO1999048525A1 (fr) * 1998-03-25 1999-09-30 Smithkline Beecham Biologicals S.A. Composition de vaccin contre hib/dtpa et ses methodes de preparation

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0835663A2 (fr) 1992-05-23 1998-04-15 SMITHKLINE BEECHAM BIOLOGICALS s.a. Vaccins combinés contenant des antigènes de surface du virus de l'Hépatite B et d'autres antigènes
KR100385711B1 (ko) * 2000-07-05 2003-05-27 녹십자백신 주식회사 디프테리아, 파상풍 톡소이드와 백일해균 및ｂ형간염표면항원을 포함한 4가 혼합백신 및 그 제조방법
US8409587B2 (en) 2002-11-01 2013-04-02 Glaxosmithkline Biologicals S.A. Immunogenic composition
KR101058978B1 (ko) * 2002-11-01 2011-08-23 글락소스미스클라인 바이오로지칼즈 에스.에이. 면역원성 조성물
EP2206515A1 (fr) 2005-03-17 2010-07-14 Novartis Vaccines and Diagnostics S.r.l. Vaccins combinés à antigènes de coqueluche à cellules entières
US8562999B2 (en) 2006-04-26 2013-10-22 Wyeth Llc Formulations which stabilize and inhibit precipitation of immunogenic compositions
WO2007127665A3 (fr) * 2006-04-26 2008-11-13 Wyeth Corp Nouvelles formulations stabilisant et inhibant la précipitation de compositions immunogènes
WO2007127665A2 (fr) * 2006-04-26 2007-11-08 Wyeth Nouvelles formulations stabilisant et inhibant la précipitation de compositions immunogènes
RU2482878C2 (ru) * 2006-04-26 2013-05-27 Вайет Новые составы, которые стабилизируют иммуногенные композиции и ингибируют их осаждение
US7935787B2 (en) 2006-04-26 2011-05-03 Wyeth Llc Formulations which stabilize and inhibit precipitation of immunogenic compositions
EP2676679A3 (fr) * 2006-04-26 2014-01-01 Wyeth LLC Formulations stabilisant et inhibant la précipitation de compositions immunogènes
EP2679245A3 (fr) * 2006-04-26 2014-01-15 Wyeth LLC Formulations stabilisant et inhibant la précipitation de compositions immunogènes
CN104857524A (zh) * 2006-04-26 2015-08-26 惠氏公司 使免疫原性组合物稳定且抑制其沉淀的新颖调配物
EP2529750A1 (fr) 2008-10-24 2012-12-05 Panacea Biotec Ltd. Combination vaccinale contre la coqueluche (vaccin cellulaire entier)
US9095567B2 (en) 2010-06-04 2015-08-04 Wyeth Llc Vaccine formulations
EP2629792A1 (fr) * 2010-10-18 2013-08-28 Sanofi Pasteur Procédé de stockage d'un vaccin comprenant un adjuvant à base d'aluminium
EP2629792B1 (fr) * 2010-10-18 2016-11-23 Sanofi Pasteur Procede de stockage d'un vaccin contenant un adjuvant d'aluminium
US9938055B2 (en) 2010-10-18 2018-04-10 Sanofi Pasteur Method of storing a vaccine containing an aluminum adjuvant

Also Published As

Publication number Publication date
KR100385711B1 (ko) 2003-05-27
CN1383384A (zh) 2002-12-04
KR20020005081A (ko) 2002-01-17
CN1211121C (zh) 2005-07-20
AU2001269569A1 (en) 2002-01-30

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