DK2763525T3 - Stabilisering af polypeptider - Google Patents

Stabilisering af polypeptider Download PDF

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Publication number
DK2763525T3
DK2763525T3 DK12772389.8T DK12772389T DK2763525T3 DK 2763525 T3 DK2763525 T3 DK 2763525T3 DK 12772389 T DK12772389 T DK 12772389T DK 2763525 T3 DK2763525 T3 DK 2763525T3
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Denmark
Prior art keywords
antibody
formula
ester
compound
acceptable salt
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DK12772389.8T
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English (en)
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Jeffrey Drew
David Thomas Woodward
Stephen Ward
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Stabilitech Ltd
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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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/84—Products or compounds obtained by lyophilisation, freeze-drying

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (15)

1. Fremgangsmåde til konservering af et polypeptid omfattende: (a) tilvejebringelse af en vandig opløsning af: (i) polypeptidet, (ii) ét eller flere sukkere, hvor sukkerkoncentrationen, eller den totale sukkerkoncentration, er fra 0,05M til 3M, og (iii) 0,001M til 2,5M af en forbindelse med formlen (I) eller et fysiologisk acceptabelt salt eller en ester deraf:
hvor Ri repræsenterer hydrogen eller C^-alkyl, R2 repræsenterer hydrogen eller Ci-4-alkyl, R3 repræsenterer Ci-4-alkyl og R4 repræsenterer hydrogen; og/eller 0,001M til 2,5M af en forbindelse med formlen (II) eller et fysiologisk acceptabelt salt eller en ester deraf:
hvor X repræsenterer -8(())2- og Ra og Rb uafhængigt repræsenterer Ci-4-alkyl; og (b) frysetørring af opløsningen for at danne en sammensætning, hvori polypeptidet er inkorporeret.
2. Fremgangsmåde ifølge krav 1, hvor den vandige opløsning omfatter en forbindelse med formlen (I) eller et fysiologisk acceptabelt salt eller ester deraf eller en forbindelse med formlen (II) eller et fysiologisk acceptabelt salt eller en ester deraf.
3. Fremgangsmåde ifølge krav 1, hvor den vandige opløsning omfatter en forbindelse med formlen (T) eller et fysiologisk acceptabelt salt eller en ester deraf og en forbindelse med formlen (II) eller et fysiologisk acceptabelt salt eller en ester deraf.
4. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor forbindelsen med formlen (I) er dimethylglycin eller et fysiologisk acceptabelt salt eller en ester deraf.
5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor forbindelsen med formlen (II) er dimethylsulfon.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor (a) koncentrationen af forbindelsen med formlen (I) eller et fysiologisk acceptabelt salt eller en ester deraf er fra 0,01 til 1,5M eller 0,1M til 1M eller 0,3M til 0,7M, og/eller (b) koncentrationen af forbindelsen med formlen (II) eller et fysiologisk acceptabelt salt eller en ester deraf er fra 0,01 til 1,5M eller 0,1M til 1M eller 0,3M til 0,7M, og/eller (c) sukkerkoncentrationen, eller den totale sukkerkoncentration, er fra 0,05M til 2M eller 0,05 til 1M.
7. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor (a) det ene eller flere sukkere omfatter et ikke reducerende sukker eller sukkeralkohol, og/eller (b) to eller flere sukkere anvendes og ét af sukkerne er saccharose, og/eller (c) to eller flere sukkere anvendes, ét af sukkerne er saccharose og forholdet af koncentrationen af saccharose i forhold det eller de andre sukkere er fra 1:1 til 20:1.
8. Fremgangsmåde ifølge krav 7(b) eller (c), hvor det andet sukker er raffinose.
9. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 6, hvor ét sukker er til stede, der cr mannitol.
10. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor (a) den vandige opløsning frysetørres i hætteglas eller ampuller, der derefter eventuelt forsegles.
11. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor polypeptidet er: (a) et hormon, en vækstfaktor, et peptid eller cytokin; (b) et antistof eller antigen- eller ligand-bindende fragment deraf; (c) en oxidoreduktase, en transferase, en hydrolase, en lyase, en isomerase eller en ligase; eller (d) et vaccineimmunogen.
12. Fremgangsmåde ifølge krav 11, hvor polypeptidet er: (i) et tachykininpeptid, et vasoaktivt intestinalpeptid, et pankreatisk polypeptidrelateret peptid, et opioidpeptid eller et calcintoninpeptid; (ii) et monoklonalt antistof eller fragment deraf; (iii) et kimærisk, humaniseret eller humant antistof eller fragment deraf (iv) en oxidoreduktase, en transferase, en hydrolase, en lyase, en isomerase eller en ligase; eller (v) et fuldlængde virus- eller bakterieprotein, glycoprotein eller lipoprotein; eller et fragment deraf.
13. Fremgangsmåde til fremstilling af en vaccine, der inkorporer en vaccine, hvilken fremgangsmåde omfatter: (a) tilvejebringelse af en vandig opløsning af (i) et vaccineimmunogen som defineret i krav 11 eller 12, (ii) 0,001M til 2,5M af en forbindelse med formlen (1) eller et fysiologisk acceptabelt salt eller en ester deraf som defineret i krav 1 eller 4, og/eller 0,001M til 2,5M af en forbindelse med formlen (II) eller et fysiologisk acceptabelt salt eller en ester deraf som defineret i krav 1 eller 5 og (iii) ét eller flere sukkere, hvor sukkerkoncentrationen, eller den totale sukkerkoncentration, er fra 0,05M til 3M; og (b) eventuelt tilsætning af et adjuvans, en buffer, et antibiotikum og/eller additiv til blandingen; og (c) frysetørring af opløsningen for at danne en sammensætning eller fast sammensætning, hvori vaccineimmunogenet er inkorporeret.
14. Sammensætning, der kan opnås ved hjælp af en fremgangsmåde som defineret i et hvilket som helst af kravene 1 til 13, hvor sammensætningen er en fast, frysetørret matrix, hvori polypeptidet eller vaccineimmunogenet er inkorporeret.
15. Anvendelse af en forbindelse med formlen (I) eller et fysiologisk acceptabelt salt eller en ester deraf som defineret i krav 1 eller 4 ved en koncentration på 0,001M til 2,5M og/eller en forbindelse med formlen (II) eller et fysiologisk acceptabelt salt eller en ester deraf som defineret i krav 1 eller 5 ved en koncentration på 0,001M til 2,5M og ét eller flere sukkere, hvor sukkerkoncentrationen, eller den totale sukkerkoncentration, er fra 0,05M til 3M, til konservering af et polypeptid som defineret i et hvilket som helst af kravene 1, 11 eller 12 under frysetørring.
DK12772389.8T 2011-10-05 2012-10-05 Stabilisering af polypeptider DK2763525T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1117233.5A GB201117233D0 (en) 2011-10-05 2011-10-05 Stabilisation of polypeptides
PCT/GB2012/052477 WO2013050780A1 (en) 2011-10-05 2012-10-05 Stabilisation of polypeptides

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DK2763525T3 true DK2763525T3 (da) 2017-08-28

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US (2) US10029007B2 (da)
EP (1) EP2763525B1 (da)
JP (1) JP6196975B2 (da)
AU (1) AU2012320243B2 (da)
CA (1) CA2851176C (da)
DK (1) DK2763525T3 (da)
ES (1) ES2633897T3 (da)
GB (1) GB201117233D0 (da)
HU (1) HUE035619T2 (da)
WO (1) WO2013050780A1 (da)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112012025047A2 (pt) 2010-03-31 2016-06-21 Stabilitech Ltd formulações líquidas estabilizadas
ES2543795T3 (es) 2010-03-31 2015-08-21 Stabilitech Ltd. Estabilización de partículas virales
GB201117233D0 (en) 2011-10-05 2011-11-16 Stabilitech Ltd Stabilisation of polypeptides
GB201406569D0 (en) 2014-04-11 2014-05-28 Stabilitech Ltd Vaccine compositions
GB2562241B (en) * 2017-05-08 2022-04-06 Stabilitech Biopharma Ltd Vaccine compositions
CN107929749A (zh) * 2017-11-27 2018-04-20 云南生物制药有限公司 猪多杀性巴氏杆菌病活疫苗保护剂及其制备方法
KR102050286B1 (ko) * 2018-02-08 2019-12-02 전북대학교산학협력단 건강기능식품 및 이의 제조방법
CN110314223B (zh) * 2019-05-27 2022-12-06 暨南大学 Fgf-2纳米抗体作为蛋白质和/或多肽保护剂的应用

Family Cites Families (90)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3927208A (en) 1973-05-14 1975-12-16 Rit Rech Ind Therapeut Live bovine adenovirus vaccines, preparation thereof and method of vaccination using them
US4631189A (en) * 1980-03-10 1986-12-23 Da Vinci Laboratories, a division of FoodScience Corporation N,N-dimethylglycine and use in immune response
JPS6013718A (ja) 1983-07-05 1985-01-24 Chemo Sero Therapeut Res Inst Ｂ型肝炎ワクチン
JPS60193925A (ja) 1984-03-13 1985-10-02 Chemo Sero Therapeut Res Inst 凍結乾燥製剤化ワクチン
US4808700A (en) 1984-07-09 1989-02-28 Praxis Biologics, Inc. Immunogenic conjugates of non-toxic E. coli LT-B enterotoxin subunit and capsular polymers
JPS61189228A (ja) 1985-02-19 1986-08-22 Nippon Sekijiyuujishiya 血液凝固第８因子製剤の製法
US4950596A (en) 1985-03-04 1990-08-21 The Dow Chemical Company Stabilization of intracellular enzymes
JPS6238173A (ja) 1985-08-13 1987-02-19 三菱レイヨン株式会社 抗血液凝固剤
US5169758A (en) 1986-05-02 1992-12-08 Boehringer Mannheim Gmbh Stabilized, NAD(P)H-dependent, soluble nitrate reductase, a process for the preparation thereof and a reagent containing it
US4816568A (en) * 1986-05-16 1989-03-28 International Minerals & Chemical Corp. Stabilization of growth hormones
NZ221306A (en) 1986-08-15 1990-02-26 Commw Scient Ind Res Org 2-component immunoadjuvant comprising a mycobacterial free immunoadjuvant oil and a polycationic polyelectrolyte immunoadjuvant and vaccines thereof
US4980277A (en) 1987-10-16 1990-12-25 Cultor Ltd. Cryoprotectant solution and method
WO1989011297A1 (en) * 1988-05-27 1989-11-30 Centocor, Inc. Freeze-dried formulation for antibody products
GB8826429D0 (en) 1988-11-11 1988-12-14 Univ Leeds Ind Service Ltd Enzyme stabilisation systems
WO1991002543A1 (en) 1989-08-15 1991-03-07 Massachusetts Institute Of Technology Stabilized vaccine compositions
CA2051092C (en) 1990-09-12 2002-07-23 Stephen A. Livesey Method and apparatus for cryopreparation, dry stabilization and rehydration of biological suspensions
WO1993000807A1 (en) 1991-07-03 1993-01-21 Cryolife, Inc. Method for stabilization of biomaterials
RU2099418C1 (ru) 1991-11-21 1997-12-20 Лонца Аг Фрагмент днк, обеспечивающий использование бетаина, рекомбинантная плазмидная днк с фрагментом днк, обеспечивающим использование бетаина, штамм бактерий rhizobium/agrobacterium, предназначенный для стабильного хранения плазмиды с фрагментом днк, способ получения штамма бактерий
ZA936095B (en) 1992-08-21 1994-03-14 Univ Melbourne Cytokine applications.
FR2698879B1 (fr) 1992-12-09 1995-01-13 Rhone Poulenc Biochimie gellules modifiées au niveau du catabolisme de la bétaïne, préparation et utilisations, notamment pour la production de métabolites ou d'enzymes.
GB9320782D0 (en) * 1993-10-08 1993-12-01 Univ Leeds Innovations Ltd Stabilising of proteins on solution
WO1995011700A1 (en) 1993-10-29 1995-05-04 Pharmos Corp. Submicron emulsions as vaccine adjuvants
US5580856A (en) * 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
US5965438A (en) 1995-06-07 1999-10-12 Phyton, Inc. Cryopreservation of plant cells
PT1516628E (pt) 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
GB9521806D0 (en) 1995-10-25 1996-01-03 Cortecs Ltd Preservation methods
FR2746109B1 (fr) 1996-03-12 1998-04-17 Rhone Poulenc Rorer Sa Milieu pour la conservation de materiel biologique
US20070179096A1 (en) * 1996-04-24 2007-08-02 Novo Nordisk A/S Pharmaceutical Formulation
US6037116A (en) 1996-06-14 2000-03-14 Biostore New Zealand, Ltd. Compositions comprising betaine, sodium citrate and sodium chloride and methods for the preservation of biological materials
AU707186B2 (en) 1997-07-01 1999-07-01 Transgene S.A. Compositions useful for transferring therapeutically active substances into a target cell, and their use in gene therapy
AU5459698A (en) 1997-11-26 1999-06-15 Universal Preservation Technologies, Inc. Preservation of sensitive biological samples by vitrification
ES2323991T3 (es) 1998-11-16 2009-07-28 Introgen Therapeutics, Inc. Formulacion de adenovirus para terapia genica.
US6689600B1 (en) 1998-11-16 2004-02-10 Introgen Therapeutics, Inc. Formulation of adenovirus for gene therapy
AUPQ347199A0 (en) 1999-10-15 1999-11-11 Csl Limited Novel polypeptide fragments
IL153241A0 (en) 2000-06-08 2003-07-06 Powderject Vaccines Inc Powder compositions
DE10041515A1 (de) 2000-08-24 2002-03-14 Gerold Schuler Verfahren zur Herstellung gebrauchsfertiger, Antigen-beladener oder -unbeladener, kryokonservierter reifer dendritischer Zellen
US20040110267A1 (en) 2000-12-15 2004-06-10 Stratagene Room temperature stable competent cells
WO2002101412A2 (en) 2001-06-08 2002-12-19 Powderject Vaccines, Inc. Spray freeze-dried compositions
US7101693B2 (en) 2001-09-07 2006-09-05 Brigham Young University Plasticized hydrophilic glasses for improved stabilization of biological agents
JP4936618B2 (ja) 2001-09-21 2012-05-23 株式会社ノエビア 微細エマルション組成物
US20040161776A1 (en) 2001-10-23 2004-08-19 Maddon Paul J. PSMA formulations and uses thereof
AU2003202472B2 (en) * 2001-12-28 2009-11-26 Kyowa Kirin Co., Ltd. Antibodies against fibroblast growth factor 23
EP1946776B1 (en) 2002-02-27 2017-01-18 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
JP2003261591A (ja) * 2002-03-08 2003-09-19 Koji Hayade 凍結乾燥安定剤
AU2003240437A1 (en) 2002-06-27 2004-01-19 Novo Nordisk A/S Use of dimethyl sulfone as isotonicity agent
AU2003247128A1 (en) 2002-07-10 2004-02-02 Transgene S.A. Modified adenoviral fiber with ablated to cellular receptors
WO2004035818A1 (en) 2002-10-21 2004-04-29 Biotage Ab Use of osmolytes to heat stabilise luciferase and/or apyrase
MXPA05006147A (es) 2002-12-10 2005-08-26 Schering Plough Ltd Ligando del activador del receptor de nf-kb de canino, y metodos para preparar y usar el mismo.
PL1633391T3 (pl) 2003-06-03 2012-03-30 Novo Nordisk As Stabilizowane farmaceutycznie kompozycje peptydowe
CA2528727A1 (en) 2003-06-10 2004-12-16 The University Of Melbourne Immunomodulating compositions, uses therefor and processes for their production
US20060247167A1 (en) 2003-09-01 2006-11-02 Novo Nordisk A/S Stable formulations of peptides
US7642077B2 (en) 2003-12-08 2010-01-05 Genencor International, Inc. Biocomposite comprising co-precipitate of enzyme, silicate and polyamine
EP1711619A4 (en) 2003-12-30 2007-04-11 Virumar Pituach Tarkivin Ltd INTEGRATED VIRUS COMPLEXES, METHOD FOR THE MANUFACTURE THEREOF, VACCINES CONTAINING THEM AND METHOD FOR THE USE THEREOF
US8092788B2 (en) 2004-03-03 2012-01-10 Revance Therapeutics, Inc. Compositions and methods for topical diagnostic and therapeutic transport
US20060058238A1 (en) 2004-09-15 2006-03-16 Lee Laurent-Applegate Fetal skin cell protein compositions for the treatment of skin conditions, disorders or diseases and methods of making and using the same
CN101060831B (zh) 2004-10-01 2010-06-23 拉姆斯科股份有限公司 可方便植入的缓释药物组合物
PL1824460T3 (pl) 2004-11-10 2015-09-30 Tolmar Therapeutics Inc Stabilizowany polimerowy układ dostarczania
PA8661401A1 (es) 2005-01-28 2006-09-08 Wyeth Corp Formulaciones del liquido polipeptido estabilizado
GB0502661D0 (en) 2005-02-09 2005-03-16 Stabilitech Ltd A desiccated product
FR2881985B1 (fr) 2005-02-11 2009-05-08 A P C A Assemblee Permanente D Materiau multicouches au moins partiellement biodegradable et procede de fabrication correspondant
TWI398272B (zh) 2005-03-08 2013-06-11 Intervet Int Bv 化學定義的安定劑
CN101155914B (zh) 2005-04-08 2013-03-06 阿戈斯治疗公司 树状细胞组合物和方法
US8784843B2 (en) 2005-09-16 2014-07-22 Merial Limited Stabilizers for freeze-dried vaccines
RU2008117396A (ru) 2005-10-04 2009-11-10 Альк-Абелло А/С (Dk) Твердая вакцинная композиция
EP1951865A4 (en) 2005-11-21 2010-06-23 Sanofi Pasteur Ltd STABILIZING FORMULATIONS FOR RECOMBINANT VIRUSES
PT1961761E (pt) 2005-11-30 2010-12-16 Chugai Pharmaceutical Co Ltd Novos compostos peptídicos do tumor de wilms
JP5806444B2 (ja) 2005-12-02 2015-11-10 ノバルティス アーゲー 免疫原性組成物で使用するためのナノ粒子
BRPI0707796A2 (pt) 2006-02-15 2011-05-10 Imclone Systems Inc formulaÇço, e, mÉtodo de tratamento
US8021659B2 (en) * 2006-04-28 2011-09-20 Naidu Lp Coenzyme Q10, lactoferrin and angiogenin compositions and uses thereof
ES2286951B1 (es) 2006-05-26 2008-10-01 Instituto Cientifico Y Tecnologico De Navarra, S.A Nanoparticulas bioadhesivas para la administracion de moleculas biologicamente activas.
US20090053197A1 (en) * 2006-06-14 2009-02-26 Ramaekers Joseph C Transfer Factor Compositions and Methods
CA2668417A1 (en) 2006-11-03 2008-05-15 Alphavax, Inc. Alphavirus and alphavirus replicon particle formulations and methods
GB0705245D0 (en) 2007-03-19 2007-04-25 Stabilitech Ltd Stable biological products
DK2829282T3 (da) 2007-03-22 2018-01-02 Univ Colorado Regents Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning
MX2009012964A (es) 2007-06-01 2010-01-14 Acologix Inc Formulacion de peptido estable a alta temperatura.
CA2692231A1 (en) 2007-06-29 2009-01-08 Advanced Technologies And Regenerative Medicine, Llc Liquid protein formulations comprising gdf-5 for use at elevated temperatures
CN101835479A (zh) 2007-07-25 2010-09-15 佰欧益有限公司 多系祖细胞分化为软骨细胞
US20090123436A1 (en) 2007-11-08 2009-05-14 Surmodics, Inc. Cryopreservative compositions and methods
AU2009236459B2 (en) * 2008-04-14 2013-07-25 Advanced Technologies And Regenerative Medicine, Llc Liquid buffered GDF-5 formulations
US20110212127A1 (en) 2008-09-24 2011-09-01 Stabilitech Ltd. Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine
BRPI0918988A2 (pt) 2008-09-24 2015-12-01 Stabilitech Ltd métodos para preservar um polipeptídeo e um imunógeno de vacina, e para preparar uma vacina, pó seco, produto preservado, frasco selado, ampola ou seringa, uso de um excipiente, e, vacina.
CN102202688B (zh) 2008-11-07 2017-04-12 印度血清研究所私人有限公司 稳定、干燥的轮状病毒疫苗、其组合物和制备其的方法
EP2430195B1 (en) * 2009-05-11 2019-01-23 Biomatrica, INC. Compositions and methods for biological sample storage
CN101670104A (zh) 2009-09-24 2010-03-17 浙江大学 一种含人参皂甙的油佐剂及其制备方法
WO2011109415A2 (en) * 2010-03-02 2011-09-09 Amgen Inc. Reducing viscosity of pharmaceutical formulations
ES2543795T3 (es) 2010-03-31 2015-08-21 Stabilitech Ltd. Estabilización de partículas virales
BR112012025047A2 (pt) 2010-03-31 2016-06-21 Stabilitech Ltd formulações líquidas estabilizadas
DK2552410T3 (da) 2010-03-31 2019-02-18 Stabilitech Biopharma Ltd Fremgangsmåde til konservering af alunadjuvanser og vacciner med alunadjuvanser
GB201117233D0 (en) 2011-10-05 2011-11-16 Stabilitech Ltd Stabilisation of polypeptides
GB201406569D0 (en) 2014-04-11 2014-05-28 Stabilitech Ltd Vaccine compositions

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GB201117233D0 (en) 2011-11-16
CA2851176C (en) 2020-03-24
US20140294757A1 (en) 2014-10-02
JP2014530218A (ja) 2014-11-17
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AU2012320243A1 (en) 2014-04-17
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