DK2277536T3 - Oprensning af bakterielle kapselpolysaccharider - Google Patents

Oprensning af bakterielle kapselpolysaccharider Download PDF

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Publication number
DK2277536T3
DK2277536T3 DK10179797.5T DK10179797T DK2277536T3 DK 2277536 T3 DK2277536 T3 DK 2277536T3 DK 10179797 T DK10179797 T DK 10179797T DK 2277536 T3 DK2277536 T3 DK 2277536T3
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polysaccharide
vol
serogroup
vaccine
saccharide
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DK10179797.5T
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Paolo Costantino
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Glaxosmithkline Biologicals Sa
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    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/095—Neisseria
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
    • A23J1/00—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites
    • A23J1/04—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites from fish or other sea animals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
    • A23J1/00—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites
    • A23J1/20—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites from milk, e.g. casein; from whey
    • A23J1/205—Obtaining protein compositions for foodstuffs; Bulk opening of eggs and separation of yolks from whites from milk, e.g. casein; from whey from whey, e.g. lactalbumine
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/102—Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • 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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H15/00—Compounds containing hydrocarbon or substituted hydrocarbon radicals directly attached to hetero atoms of saccharide radicals
    • C07H15/02—Acyclic radicals, not substituted by cyclic structures
    • C07H15/04—Acyclic radicals, not substituted by cyclic structures attached to an oxygen atom of the saccharide radical
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/22—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Neisseriaceae (F)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/285—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Pasteurellaceae (F), e.g. Haemophilus influenza
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09F—NATURAL RESINS; FRENCH POLISH; DRYING-OILS; OIL DRYING AGENTS, i.e. SICCATIVES; TURPENTINE
    • C09F1/00—Obtaining purification, or chemical modification of natural resins, e.g. oleo-resins
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09G—POLISHING COMPOSITIONS; SKI WAXES
    • C09G1/00—Polishing compositions
    • 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
    • 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S424/00—Drug, bio-affecting and body treating compositions
    • Y10S424/831—Drug, bio-affecting and body treating compositions involving capsular polysaccharide of bacterium, e.g. polyribosyl ribitol phosphate

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Formation And Processing Of Food Products (AREA)

Claims (17)

  1. PATENTKRÅ Ψ
    1. Fremgangsmåde til oprensning af et bakterielt kapse! poly sacchart d, omfattende trinnene (a) udfæidning af polysaccharidet, (b) opiøsning af det udfældede poiysaccharid ved anvendelse af en alkohol, (c) behandling af det i trin (b) opnåede poiysaccharid til fjernelse af kontaminanter ved anvendelse af ét eller flere trin med størrelsesfiltrering eller ultrafiltrering, derefter (d) udfældning af polysaccharidet opnået i trin (c) ved udskiftning af kationer, hvor der i trin (a) anvendes ét eller flere kationiske detergenter med den følgende generelle formel: R; R< — N* — X Ri hvor: Ri, R? og Rs er ens eller forskellige og hver betegner afkyl eller aryl; eller Rs. og R2 sammen med nitrogenatomet, hvortii disse er bundet, danner en 5- eller 6-ieddet mæt-tet heterocykiisk ring, og R:< beteger aikyi eller aryi; eller RJr R:> og R;f sammen med nitrogenatomet, hvortil disse er bundet, danner en 5- eller 6-feddet heterocykiisk ring, der er umættet ved nitrogenatomet, R<s betegner alkyl eller aryl, og X“ betegner en anion.
  2. 2. Fremgangsmåde ifølge krav 1, hvor der i trin (a) anvendes cetyltri methyl a mmoni-umbromid.
  3. 3. Fremgangsmåde ifølge krav 1 eller krav 2, hvor alkoholen anvendt I trin (b) omfatter ethanol,
  4. 4. Fremgangsmåde ifølge krav 3, hvor ethanolet har en sfutkoncentration på mellem 50% og 95%,
  5. 5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor det bakterielle kapselpoiysaccharid er et menlngokokpolysaccharid, og størrelsesfiitrerlngen t trin (c) er gennem et 0,22 pm filter.
  6. 6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor udfælde ningen i trin (d) er ved tilsætning af calcium- eller natriumsalte
  7. 7. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor det bakterielle kapselpoiysaccharid er fra N. meningitidis.
  8. 8. Fremgangsmåde iføige krav 7, hvor N, meningitidis er fra serogruppe A, W135 el- ier Y.
  9. 9. Fremgangsmåde ifølge et hvilket som helst s# kravene 1 til 6, hvor det bakterielle kapselpoiysaccharid er fra Haemophilus inf/uenzae eller Streptococcus pneumoniaei
  10. 10. Fremgangsmåde iføige et hvilket som helst af de foregående krav, der yderligere omfatter hydrolyse ti! tii dannelse af oligosaccharider.
  11. 11. Fremgangsmåde til oprensning og konjugering af et bakterielt kapsel poiysaccharid til et bærerprotein omfattende: oprensning af polysaccharidet ved fremgangsmåden ifølge et'"Hvilket som heist af de foregående krav og konjugering af poiysaccharidet til et bærerprotein,
  12. 12, Fremgangsmåde ifølge krav li, hvor bærerproteinet er difteri eller tetanustoxo-id.
  13. 13, Fremgangsmåde til fremstilling af en blanding omfattende fremgangsmåden ifølge et bviiket som helst af de foregående ktav og yderligere omfattende trinnet at blande poiysaccharidet elier konjugatet med andre biologiske molekyler til opnåelse af blandingen,
  14. 14, Fremgangsmåde ifølge krav 13, hvor i) de yderligere biologiske molekyler er valgt fra gruppen bestående af: saccbaridantigener fra serogruppe C af N, meningstidis, og proteinantigener fra serogruppe B af N, meningitidis, eller ii) saccharidantigener fra N. meningitidis- stammerne A, C, W135 og/e!ler Y blandes,
  15. 15, Fremgangsmåde til formulering af en vaccine omfattende fremgangsmåden ifølge et hvilket som helst af de foregående krav og yderligere omfattende ét eller flere trin i form af vaccineformuiering,
  16. 16, Fremgangsmåde Ifølge krav 15, hvor trionet/trinnene i form af vaccineformuie-ring omfatter blanding af saccharidantigenet/~generoe med en adjuvans,
  17. 17, Fremgangsmåde ifølge krav 16, hvor adjuvansen er et aluminiumphosphat og/eiler et aluminiumhydroxid.
DK10179797.5T 2001-06-20 2002-06-20 Oprensning af bakterielle kapselpolysaccharider DK2277536T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0115176.0A GB0115176D0 (en) 2001-06-20 2001-06-20 Capular polysaccharide solubilisation and combination vaccines
EP10007477.2A EP2263688B2 (en) 2001-06-20 2002-06-20 Neisseria meningitidis combination vaccines

Publications (1)

Publication Number Publication Date
DK2277536T3 true DK2277536T3 (da) 2018-02-26

Family

ID=9917070

Family Applications (6)

Application Number Title Priority Date Filing Date
DK10179797.5T DK2277536T3 (da) 2001-06-20 2002-06-20 Oprensning af bakterielle kapselpolysaccharider
DK02755452.6T DK1401489T4 (da) 2001-06-20 2002-06-20 Solubilisering af kapselpolysaccharid
DK09075005.0T DK2184071T3 (da) 2001-06-20 2002-06-20 Kapselformige polysaccharidopløsnings- og kombinationsvacciner
DK10007477.2T DK2263688T4 (da) 2001-06-20 2002-06-20 Kombinationsvacciner mod neisseria meningitidis
DK09075006.8T DK2189165T3 (da) 2001-06-20 2002-06-20 Kapselpolysaccharidsolubilisering og kombinationsvacciner
DK06075175.7T DK1741442T3 (da) 2001-06-20 2002-06-20 Neisseria meningitidis-kombinationavacciner

Family Applications After (5)

Application Number Title Priority Date Filing Date
DK02755452.6T DK1401489T4 (da) 2001-06-20 2002-06-20 Solubilisering af kapselpolysaccharid
DK09075005.0T DK2184071T3 (da) 2001-06-20 2002-06-20 Kapselformige polysaccharidopløsnings- og kombinationsvacciner
DK10007477.2T DK2263688T4 (da) 2001-06-20 2002-06-20 Kombinationsvacciner mod neisseria meningitidis
DK09075006.8T DK2189165T3 (da) 2001-06-20 2002-06-20 Kapselpolysaccharidsolubilisering og kombinationsvacciner
DK06075175.7T DK1741442T3 (da) 2001-06-20 2002-06-20 Neisseria meningitidis-kombinationavacciner

Country Status (23)

Country Link
US (9) US8753651B2 (da)
EP (10) EP1741442B1 (da)
JP (4) JP5075317B2 (da)
CN (4) CN101524533A (da)
AT (3) ATE556718T1 (da)
AU (3) AU2002321716B2 (da)
BE (4) BE2010C033I2 (da)
BR (2) BRPI0210590B8 (da)
CA (3) CA2450203C (da)
CY (6) CY1110820T1 (da)
DE (6) DE122010000041I1 (da)
DK (6) DK2277536T3 (da)
ES (9) ES2662015T3 (da)
FR (4) FR10C0043I1 (da)
GB (1) GB0115176D0 (da)
LU (4) LU91734I2 (da)
MX (1) MXPA03011462A (da)
NL (3) NL300460I2 (da)
NZ (2) NZ529881A (da)
PT (6) PT2263688E (da)
RU (2) RU2381814C2 (da)
TR (2) TR201808026T4 (da)
WO (1) WO2003007985A2 (da)

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