DE06025470T1 - Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen - Google Patents
Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen Download PDFInfo
- Publication number
- DE06025470T1 DE06025470T1 DE06025470T DE06025470T DE06025470T1 DE 06025470 T1 DE06025470 T1 DE 06025470T1 DE 06025470 T DE06025470 T DE 06025470T DE 06025470 T DE06025470 T DE 06025470T DE 06025470 T1 DE06025470 T1 DE 06025470T1
- Authority
- DE
- Germany
- Prior art keywords
- polysaccharide
- protein
- ammonium sulfate
- mixture
- membrane
- 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.)
- Pending
Links
- 108010060123 Conjugate Vaccines Proteins 0.000 title claims abstract 5
- 229940031670 conjugate vaccine Drugs 0.000 title claims abstract 5
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 title claims abstract 4
- 229910052921 ammonium sulfate Inorganic materials 0.000 title claims abstract 4
- 235000011130 ammonium sulphate Nutrition 0.000 title claims abstract 4
- 238000000746 purification Methods 0.000 title 1
- 238000000108 ultra-filtration Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract 14
- 229920001282 polysaccharide Polymers 0.000 claims abstract 11
- 239000005017 polysaccharide Substances 0.000 claims abstract 11
- 150000004676 glycans Chemical class 0.000 claims abstract 7
- 239000012528 membrane Substances 0.000 claims abstract 7
- 239000000203 mixture Substances 0.000 claims abstract 6
- 238000001914 filtration Methods 0.000 claims abstract 2
- 238000009738 saturating Methods 0.000 claims abstract 2
- 239000004695 Polyether sulfone Substances 0.000 claims 2
- 230000002209 hydrophobic effect Effects 0.000 claims 2
- 229920006393 polyether sulfone Polymers 0.000 claims 2
- 239000004627 regenerated cellulose Substances 0.000 claims 2
- 241000894006 Bacteria Species 0.000 claims 1
- 241000588650 Neisseria meningitidis Species 0.000 claims 1
- 241000193998 Streptococcus pneumoniae Species 0.000 claims 1
- 229960003983 diphtheria toxoid Drugs 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 229940031000 streptococcus pneumoniae Drugs 0.000 claims 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
- A61K39/02—Bacterial antigens
- A61K39/095—Neisseria
-
- 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
- A61K39/385—Haptens or antigens, bound to carriers
-
- 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
- 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
- A61K2039/60—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]
-
- 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
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
- Y10T436/25375—Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
Verfahren
zur Entfernung von ungebundenem Polysaccharid von Protein-Polysaccharid-Konjugat-Vakzinen
in einem Gemisch von Protein-Polysaccharid-Konjugat und ungebundenem
Polysaccharid, wobei das Verfahren ein Zusetzen von sättigenden
Mengen an Ammoniumsulfat zu dem Gemisch umfasst, gefolgt von Filtration
des Gemisches durch eine semipermeable Membran.
Claims (12)
- Verfahren zur Entfernung von ungebundenem Polysaccharid von Protein-Polysaccharid-Konjugat-Vakzinen in einem Gemisch von Protein-Polysaccharid-Konjugat und ungebundenem Polysaccharid, wobei das Verfahren ein Zusetzen von sättigenden Mengen an Ammoniumsulfat zu dem Gemisch umfasst, gefolgt von Filtration des Gemisches durch eine semipermeable Membran.
- Verfahren nach Anspruch 1, wobei die semipermeable Membran hydrophob ist.
- Verfahren nach Anspruch 2, wobei die hydrophobe Membran aus Polyethersulfon zusammengesetzt ist.
- Verfahren nach Anspruch 3, wobei die Polyethersulfonmembran einen Molekulargewichtsausschluss von 30.000 aufweist.
- Verfahren nach Anspruch 1, wobei die semipermeable Membran hydrophil ist.
- Verfahren nach Anspruch 5, wobei die hydrophile Membran aus regenerierter Zellulose zusammengesetzt ist.
- Verfahren nach Anspruch 6, wobei die regenerierte Zellulose einen Molekulargewichtsausschluss von 30.000 aufweist.
- Verfahren nach Anspruch 1, wobei das Ammoniumsulfat bei 20 bis 60% Sättigung vorhanden ist.
- Verfahren nach Anspruch 1, wobei das Protein Diphtherietoxoid ist.
- Verfahren nach Anspruch 1, wobei das Polysaccharid kapsuläres Polysaccharid aus Bakterien ist, ausgewählt aus der Gruppe bestehend aus Streptococcus pneumoniae-Serotypen 1, 3, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F und Neisseria meningitidis-Serogruppen A, C, W-135 und Y.
- Aufgereinigte Polysaccharid-Protein-Konjugat-Vakzine, hergestellt durch das Verfahren gemäß einem der Ansprüche 1 bis 10.
- Aufgereinigte Polysaccharid-Protein-Konjugat-Vakzine gemäß Anspruch 11, die weniger als 1% an ungebundenem Polysaccharid nach Gewicht enthält.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US221728 | 1994-04-01 | ||
US09/221,728 US6146902A (en) | 1998-12-29 | 1998-12-29 | Purification of polysaccharide-protein conjugate vaccines by ultrafiltration with ammonium sulfate solutions |
Publications (1)
Publication Number | Publication Date |
---|---|
DE06025470T1 true DE06025470T1 (de) | 2007-08-02 |
Family
ID=22829099
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69934434T Expired - Lifetime DE69934434T2 (de) | 1998-12-29 | 1999-12-16 | Reinigung von polysaccharid-protein-konjugat impfstoffen durch ultrafiltration mit ammoniumsulfat-lösungen |
DE69943169T Expired - Lifetime DE69943169D1 (de) | 1998-12-29 | 1999-12-16 | Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen |
DE06025470T Pending DE06025470T1 (de) | 1998-12-29 | 1999-12-16 | Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69934434T Expired - Lifetime DE69934434T2 (de) | 1998-12-29 | 1999-12-16 | Reinigung von polysaccharid-protein-konjugat impfstoffen durch ultrafiltration mit ammoniumsulfat-lösungen |
DE69943169T Expired - Lifetime DE69943169D1 (de) | 1998-12-29 | 1999-12-16 | Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen |
Country Status (12)
Country | Link |
---|---|
US (1) | US6146902A (de) |
EP (3) | EP1762245B1 (de) |
AT (2) | ATE496633T1 (de) |
AU (1) | AU2367500A (de) |
CA (2) | CA2358022C (de) |
CY (3) | CY1105985T1 (de) |
DE (3) | DE69934434T2 (de) |
DK (2) | DK1762245T3 (de) |
ES (2) | ES2278551T3 (de) |
HK (1) | HK1106999A1 (de) |
PT (2) | PT1762245E (de) |
WO (1) | WO2000038711A2 (de) |
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AU2441402A (en) * | 2000-10-18 | 2002-04-29 | Clarity Technologies Inc | Method and device for diluting a fluid and detecting analytes within a diluted fluid |
HU230490B1 (hu) | 2001-01-23 | 2016-08-29 | Sanofi Pasteur Inc. | Multivalens, meningokokkusz-eredetű poliszaccharid és fehérje konjugátumát tartalmazó vakcina |
PT1373491E (pt) | 2001-04-04 | 2016-03-31 | Dsm Ip Assets Bv | Lactase purificada |
GB0115176D0 (en) * | 2001-06-20 | 2001-08-15 | Chiron Spa | Capular polysaccharide solubilisation and combination vaccines |
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GB0227346D0 (en) | 2002-11-22 | 2002-12-31 | Chiron Spa | 741 |
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US20070020293A1 (en) * | 2003-06-23 | 2007-01-25 | Michon Francis J | Vaccines against group neisseria meningitidis and meningococcal combinations thereof |
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FR2748476B1 (fr) * | 1996-05-07 | 1998-08-14 | Pf Medicament | Complexe immunogene, son utilisation, son procede de preparation et vaccin le contenant |
US6248334B1 (en) * | 1997-01-08 | 2001-06-19 | Henry M. Jackson Foundation For The Advancement Of Military Medicine | Process for preparing conjugate vaccines including free protein and the conjugate vaccines, immunogens, and immunogenic reagents produced by this process |
US5965714A (en) * | 1997-10-02 | 1999-10-12 | Connaught Laboratories, Inc. | Method for the covalent attachment of polysaccharides to protein molecules |
-
1998
- 1998-12-29 US US09/221,728 patent/US6146902A/en not_active Expired - Lifetime
-
1999
- 1999-12-16 AT AT06025470T patent/ATE496633T1/de active
- 1999-12-16 DK DK06025470.3T patent/DK1762245T3/da active
- 1999-12-16 DE DE69934434T patent/DE69934434T2/de not_active Expired - Lifetime
- 1999-12-16 EP EP06025470A patent/EP1762245B1/de not_active Expired - Lifetime
- 1999-12-16 ES ES06025470T patent/ES2278551T3/es not_active Expired - Lifetime
- 1999-12-16 DK DK99967388T patent/DK1140156T3/da active
- 1999-12-16 ES ES99967388T patent/ES2277462T3/es not_active Expired - Lifetime
- 1999-12-16 CA CA002358022A patent/CA2358022C/en not_active Expired - Lifetime
- 1999-12-16 AU AU23675/00A patent/AU2367500A/en not_active Abandoned
- 1999-12-16 DE DE69943169T patent/DE69943169D1/de not_active Expired - Lifetime
- 1999-12-16 DE DE06025470T patent/DE06025470T1/de active Pending
- 1999-12-16 EP EP10185779A patent/EP2292261A1/de not_active Withdrawn
- 1999-12-16 AT AT99967388T patent/ATE347906T1/de active
- 1999-12-16 PT PT06025470T patent/PT1762245E/pt unknown
- 1999-12-16 CA CA002621097A patent/CA2621097A1/en not_active Abandoned
- 1999-12-16 EP EP99967388A patent/EP1140156B1/de not_active Expired - Lifetime
- 1999-12-16 WO PCT/US1999/030109 patent/WO2000038711A2/en active IP Right Grant
- 1999-12-16 PT PT99967388T patent/PT1140156E/pt unknown
-
2007
- 2007-01-31 CY CY20071100130T patent/CY1105985T1/el unknown
- 2007-08-23 CY CY20072200004T patent/CY2200152T2/el unknown
- 2007-09-14 HK HK07110049.3A patent/HK1106999A1/xx unknown
-
2011
- 2011-04-05 CY CY20111100357T patent/CY1111375T1/el unknown
Also Published As
Publication number | Publication date |
---|---|
CY2200152T2 (el) | 2010-07-28 |
DE69943169D1 (de) | 2011-03-10 |
CY1111375T1 (el) | 2015-08-05 |
EP1140156B1 (de) | 2006-12-13 |
ES2277462T3 (es) | 2007-07-01 |
EP1762245A2 (de) | 2007-03-14 |
DE69934434D1 (de) | 2007-01-25 |
WO2000038711A3 (en) | 2000-10-19 |
DE69934434T2 (de) | 2008-01-03 |
EP2292261A1 (de) | 2011-03-09 |
WO2000038711A2 (en) | 2000-07-06 |
EP1762245B1 (de) | 2011-01-26 |
CA2358022A1 (en) | 2000-07-06 |
AU2367500A (en) | 2000-07-31 |
CA2358022C (en) | 2008-03-11 |
CY1105985T1 (el) | 2011-04-06 |
DK1762245T3 (da) | 2011-04-04 |
ES2278551T3 (es) | 2011-04-11 |
ES2278551T1 (es) | 2007-08-16 |
CA2621097A1 (en) | 2000-07-06 |
ATE496633T1 (de) | 2011-02-15 |
DK1140156T3 (da) | 2007-03-26 |
PT1140156E (pt) | 2007-02-28 |
EP1140156A2 (de) | 2001-10-10 |
US6146902A (en) | 2000-11-14 |
HK1106999A1 (en) | 2008-03-28 |
EP1762245A3 (de) | 2007-04-25 |
PT1762245E (pt) | 2011-05-02 |
ATE347906T1 (de) | 2007-01-15 |
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