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HRP20120994T1 - Stabilizirana smjesa glukocerebrozidaze - Google Patents

Stabilizirana smjesa glukocerebrozidaze Download PDF

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Publication number
HRP20120994T1
HRP20120994T1 HRP20120994TT HRP20120994T HRP20120994T1 HR P20120994 T1 HRP20120994 T1 HR P20120994T1 HR P20120994T T HRP20120994T T HR P20120994TT HR P20120994 T HRP20120994 T HR P20120994T HR P20120994 T1 HRP20120994 T1 HR P20120994T1
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Croatia
Prior art keywords
pharmaceutical composition
composition according
carbohydrate
present
gcb
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HRP20120994TT
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English (en)
Inventor
Gaozhong Zhu
Kris Lowe
Zahra Shahrokh
Vinh Nguyen
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Shire Human Genetic Therapies, Inc.
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Publication of HRP20120994T1 publication Critical patent/HRP20120994T1/hr

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    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1825—Fibroblast growth factor [FGF]
    • 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
    • A61K47/26—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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
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    • A—HUMAN NECESSITIES
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    • A61P19/00—Drugs for skeletal disorders
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
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    • A61P35/00—Antineoplastic agents
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
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    • 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
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    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/04—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01045—Glucosylceramidase (3.2.1.45), i.e. beta-glucocerebrosidase

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
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  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (38)

1. Farmaceutska kompozicija koja sadrži protein koji ima slobodni tiol i ugljikohidrat, pri čemu je ugljikohidrat prisutan u količini koja je dovoljna za održavanje stabilnosti proteina i pri čemu je pH kompozicije između 4,5 i 6,5, pri čemu je protein koji ima slobodni tiol glukocerebrozidaza (GCB) i pri čemu je ugljikohidrat saharoza.
2. Farmaceutska kompozicija prema zahtjevu 1, koja dalje sadrži antioksidans, pri čemu su antioksidans i ugljikohidrat prisutni u količinama koje su dovoljne za održavanje stabilnosti proteina.
3. Farmaceutska kompozicija prema zahtjevu 1, koja dalje sadrži surfaktant.
4. Farmaceutska kompozicija prema zahtjevu 1, pri čemu joj je stabilnost najmanje od 5-80 % veća, pod unaprijed izabranim uvjetima, od stabilnosti kompozicije koja se razlikuje po tome što ne sadrži ugljikohidrat.
5. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je ugljikohidrat prisutan u količini koja je dovoljna za povećanje stabilnosti proteina.
6. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je ugljikohidrat prisutan u količini koja je dovoljna za inhibiranje reakcije slobodnog tiola na prvoj molekuli proteina sa slobodnim tiolom na drugoj molekuli proteina kojom se formira agregat.
7. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je ugljikohidrat prisutan u količini koja je dovoljna za inhibiranje formiranja agregata koji se formira reakcijom slobodnog tiola na prvoj molekuli proteina sa slobodnim tiolom na drugoj molekuli proteina za najmanje od 5-80 %, pod unaprijed izabranim uvjetima, u usporedbi sa istom kompozicijom koja ne sadrži ugljikohidrat.
8. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je ugljikohidrat prisutan u količini koja je dovoljna da poslije čuvanja u kontejneru nepropusnom za plin, na temperaturi od 2-, u razdoblju od 6 mjeseci, kompozicija zadrži najmanje 85% stabilnosti koju je kompozicija imala prije čuvanja.
9. Farmaceutska kompozicija prema zahtjevu 8, pri čemu se čuvanje vrši na tamnom mjestu.
10. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je ugljikohidrat prisutan u količini koja je dovoljna da ona ima stabilnost koja odgovara onoj za liofiliziranu kompoziciju koja sadrži saharozu, 0,01 % polisorbata-20, pH 6,0, citrata.
11. Farmaceutska kompozicija prema zahtjevu 1, koja sadrži oko 1-40 % ugljikohidrata.
12. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je kompozicija tekućina.
13. Farmaceutska kompozicija prema zahtjevu 1, pri čemu kompozicija sadrži manje od 10 % O2.
14. Farmaceutska kompozicija prema zahtjevu 1, pri čemu se kompozicija dobija postupkom koji sadrži fizičko odstranjivanje O2 iz kompozicije.
15. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je kompozicija tekućina kompozicija GCB, pri čemu se kompozicija dobija izlaganjem kompozicije intertnom plinu i pri čemu je inertni plin prisutan u koncentracijama većim nego u okolnoj atmosferi.
16. Farmaceutska kompozicija prema zahtjevu 15, koja dalje sadrži antioksidans.
17. 17 . Farmaceutska kompozicija prema zahtjevu 16, pri čemu je antioksidans cistein, cistein-HCl ili metionin.
18. Farmaceutska kompozicija prema zahtjevu 17, pri čemu je antioksidans cistein, cistein-HCl ili metionin i prisutan je u količini između 0,001 i 10 % (tež./vol.) i ugljikohidrat je prisutan u količini između 1 i 40 % (tež./vol.).
19. Farmaceutska kompozicija prema zahtjevu 15, koja dalje sadrži surfaktant.
20. Farmaceutska kompozicija prema zahtjevu 19, pri čemu je surfaktant poloksamer 188.
21. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je kompozicija tekućina kompozicija koja sadrži GCB, pri čemu je pH kompozicije između 4,5 i 6,5, i pri čemu je ugljikohidrat prisutan u količini koja je dovoljna za održavanje biokemijskog integriteta i karakteristika bioaktivnosti GCB za taj pH.
22. Farmaceutska kompozicija prema zahtjevu 21, pri čemu je pH u granicama od 5,0 do 6,0.
23. Farmaceutska kompozicija prema zahtjevu 21, pri čemu je ugljikohidrat prisutan u količini između 1 i 40 % (tež./vol.).
24. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je kompozicija tekućina kompozicija GCB, koja sadrži GCB, antioksidans i ugljikohidrat, i pri čemu se kompozicija dobija izlaganjem kompozicije inertnom plinu.
25. Farmaceutska kompozicija prema zahtjevu 24, pri čemu kompozicija sadrži 0,1-40 mg/ml GCB, 0,001-10 % cisteina, 1-40 % saharoze, pH 5,5-6,0, i pri čemu je nivo otopljenog O2 manji od oko 10 %.
26. Farmaceutska kompozicija prema zahtjevu 24, koja dalje sadrži surfaktant.
27. Farmaceutska kompozicija prema zahtjevu 26, pri čemu je surfaktant poloksamer 188.
28. Kontejner nepropusan za plin koji sadrži farmaceutsku kompoziciju prema zahtjevu 1, proteinsku komponentu i prostor iznad nje, pri čemu je prostor iznad nje najmanje 90 % (vol./vol.) inertni plin.
29. Kontejner nepropusan za plin prema zahtjevu 28, pri čemu je taj kontejner napunjena injekcijska šprica, fiola ili ampula.
30. Kontejner nepropusan za plin prema zahtjevu 29, pri čemu je napunjena injekcijska šprica bez igle.
31. Postupak za pakovanje farmaceutske kompozicije prema zahtjevu 1, koji postupak sadrži dovođenje u kontakt GCB sa inertnim plinom da se smanji količina reaktivne vrste, i uvođenje GCB i inertnog plina u kontejner nepropusan za plin.
32. Postupak prema zahtjevu 31, pri čemu je inertni plin N2 ili Ar i reaktivna vrsta je O2.
33. Farmaceutska kompozicija prema zahtjevu 1, za primjenu u metodi liječenja pacijenta, koja metoda sadrži davanje kompozicije pacijentu.
34. Farmaceutska kompozicija prema zahtjevu 33, pri čemu je davanje IV infuzija ili subkutano davanje.
35. Farmaceutska kompozicija prema zahtjevu 15, za primjenu u metodi liječenja pacijenta koji ima deficit glukocerebrozidaze.
36. Farmaceutska kompozicija prema zahtjevu 35, pri čemu je deficit glukocerebrozidaze Gose bolest.
37. Farmaceutska kompozicija prema zahtjevu 1, pri čemu farmaceutska kompozicija ne sadrži polisorbat.
38. Farmaceutska kompozicija prema zahtjevu 28, pri čemu je proteinska komponenta u otopini.
HRP20120994TT 2006-02-07 2007-02-06 Stabilizirana smjesa glukocerebrozidaze HRP20120994T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US77155506P 2006-02-07 2006-02-07
PCT/US2007/061657 WO2007092829A2 (en) 2006-02-07 2007-02-06 Stabilized compositions of proteins having a free thiol moiety

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HRP20120994T1 true HRP20120994T1 (hr) 2012-12-31

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US (5) US7833766B2 (hr)
EP (2) EP1986612B1 (hr)
JP (8) JP5364382B2 (hr)
AR (3) AR059347A1 (hr)
AU (1) AU2007212021B2 (hr)
CA (1) CA2641588C (hr)
CY (1) CY1113199T1 (hr)
DK (1) DK1986612T3 (hr)
ES (1) ES2391657T3 (hr)
HR (1) HRP20120994T1 (hr)
PL (1) PL1986612T3 (hr)
PT (1) PT1986612E (hr)
RS (1) RS52459B (hr)
SI (1) SI1986612T1 (hr)
TW (1) TWI415630B (hr)
WO (1) WO2007092829A2 (hr)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7138262B1 (en) 2000-08-18 2006-11-21 Shire Human Genetic Therapies, Inc. High mannose proteins and methods of making high mannose proteins
RS52459B (en) * 2006-02-07 2013-02-28 Shire Human Genetic Therapies Inc. STABILIZED GLUCOCEREBROSIDASE COMPOSITIONS
US20110021980A1 (en) * 2007-08-27 2011-01-27 Ablynx N.V. Needle-free delivery device for therapeutic proteins based on single antigen-binding domains such as nanobodies®
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US11197916B2 (en) 2007-12-28 2021-12-14 Takeda Pharmaceutical Company Limited Lyophilized recombinant VWF formulations
KR20160091434A (ko) * 2007-12-28 2016-08-02 박스알타 인코퍼레이티드 재조합 ｖｗｆ 제제
EP2244729B1 (en) * 2008-01-18 2016-11-02 MedImmune, LLC Cysteine engineered antibodies for site-specific conjugation
EP2113564A1 (en) * 2008-05-01 2009-11-04 Arecor Limited Protein formulation
DK2321640T3 (en) * 2008-08-21 2017-02-27 Immunogenics Llc FORMULATION FOR ORAL ADMINISTRATION OF PROTEINS
JP2012505211A (ja) * 2008-10-10 2012-03-01 アルヴィン ファーマシューティカルズ インコーポレーティッド チモーゲンの迅速な活性化を促進する剤形
EP2349314B1 (en) 2008-10-21 2013-02-27 Baxter International Inc. Lyophilized recombinant vwf formulations
SG175188A1 (en) * 2009-05-04 2011-11-28 Abbott Biotech Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
ES2887552T3 (es) * 2009-07-28 2021-12-23 Takeda Pharmaceuticals Co Composiciones y métodos para tratar la enfermedad de Gaucher
EP2325194A1 (en) 2009-11-24 2011-05-25 Glycotope GmbH Process for the purification of glycoproteins
US20120294866A1 (en) * 2010-01-19 2012-11-22 F. Hoffmann-La Roche Ag Pharmaceutical formulation for proteins
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
US9388452B2 (en) * 2010-04-08 2016-07-12 Baxalta Incorporated Methods for modeling protein stability
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
TWI527590B (zh) 2011-06-17 2016-04-01 艾瑞斯貿易公司 Ｆｇｆ－１８之凍乾調配物
JP5990880B2 (ja) * 2011-08-31 2016-09-14 東レ株式会社 有用タンパク質組成物およびその製造方法
US9623090B2 (en) 2012-03-02 2017-04-18 Shire Human Genetic Therapies, Inc. Compositions and methods for treating type III gaucher disease
ES2524516B1 (es) * 2014-05-29 2015-03-31 Grifols Worldwide Operations Limited Procedimiento de preparación de albúmina humana con nivel de oxígeno disuelto reducido
EP3177317B1 (en) 2014-08-04 2020-03-18 CSL Limited Factor viii formulation
US9575064B2 (en) * 2014-09-02 2017-02-21 Perkinelmer Health Sciences, Inc. Methods relating to testing for lysosomal storage disorders
AR103172A1 (es) * 2014-12-22 2017-04-19 Novartis Ag Reducción selectiva de residuos de cisteina en anticuerpos il-17
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
CN107952064B (zh) * 2016-10-14 2023-10-20 江苏豪森药业集团有限公司 含有聚乙二醇洛塞那肽的药物制剂及其制备方法
UY38238A (es) * 2018-05-25 2019-12-31 Genzyme Corp Composiciones farmacéuticas para el tratamiento de la deficiencia de esfingomielinasa ácida
KR20220029733A (ko) 2019-07-04 2022-03-08 체에스엘 베링 렝나우 아게 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf)
JP7708744B2 (ja) * 2019-10-09 2025-07-15 フェニックス イーグル カンパニー ピーティーワイ リミテッド プロテアーゼのタンパク質分解活性の増強及び安定化
EP4041881A4 (en) * 2019-10-09 2023-11-08 Phoenix Eagle Company Pty Ltd IMPROVEMENT AND STABILIZATION OF THE PROTEOLYTIC ACTIVITY OF PROTEASES
EP4240757A2 (en) 2020-11-09 2023-09-13 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption
KR20240163906A (ko) * 2023-05-11 2024-11-19 씨제이제일제당 (주) 포스포리파아제 안정화용 조성물 및 이를 이용한 포스포리파아제 안정화 방법

Family Cites Families (84)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3910822A (en) 1974-03-14 1975-10-07 Us Health Isolation of glucocerebrosidase from human placental tissue
US4475196A (en) 1981-03-06 1984-10-02 Zor Clair G Instrument for locating faults in aircraft passenger reading light and attendant call control system
US4447233A (en) 1981-04-10 1984-05-08 Parker-Hannifin Corporation Medication infusion pump
US4439196A (en) 1982-03-18 1984-03-27 Merck & Co., Inc. Osmotic drug delivery system
US4522811A (en) 1982-07-08 1985-06-11 Syntex (U.S.A.) Inc. Serial injection of muramyldipeptides and liposomes enhances the anti-infective activity of muramyldipeptides
US4447224A (en) 1982-09-20 1984-05-08 Infusaid Corporation Variable flow implantable infusion apparatus
US4487603A (en) 1982-11-26 1984-12-11 Cordis Corporation Implantable microinfusion pump system
US4486194A (en) 1983-06-08 1984-12-04 James Ferrara Therapeutic device for administering medicaments through the skin
US4596556A (en) 1985-03-25 1986-06-24 Bioject, Inc. Hypodermic injection apparatus
US4925796A (en) 1986-03-07 1990-05-15 Massachusetts Institute Of Technology Method for enhancing glycoprotein stability
US5272066A (en) 1986-03-07 1993-12-21 Massachusetts Institute Of Technology Synthetic method for enhancing glycoprotein stability
US4790824A (en) 1987-06-19 1988-12-13 Bioject, Inc. Non-invasive hypodermic injection device
US4941880A (en) 1987-06-19 1990-07-17 Bioject, Inc. Pre-filled ampule and non-invasive hypodermic injection device assembly
WO1989005850A1 (en) * 1987-12-23 1989-06-29 The United States Of America, As Represented By Th Cloned dna for synthesizing unique glucocerebrosidase
US5879680A (en) 1987-12-23 1999-03-09 The United States Of America As Represented By The Department Of Health And Human Services Cloned DNA for synthesizing unique glucocerebrosidase
DE68926569T2 (de) 1988-12-23 1996-09-26 Genzyme Corp Cho-zellen befähigt enzymatisch aktive rekombinante-glukocerebrosidase zu produzieren
US5549892A (en) 1988-12-23 1996-08-27 Genzyme Corporation Enhanced in vivo uptake of glucocerebrosidase
US6451600B1 (en) 1989-12-22 2002-09-17 Genzyme Corporation Enzymatically active recombinant glucocerebrosidase
US5236838A (en) 1988-12-23 1993-08-17 Genzyme Corporation Enzymatically active recombinant glucocerebrosidase
US20020168750A1 (en) 1988-12-23 2002-11-14 James Rasmussen Enzymatically active recombinant glucocerebrosidase
US5312335A (en) 1989-11-09 1994-05-17 Bioject Inc. Needleless hypodermic injection device
US5064413A (en) 1989-11-09 1991-11-12 Bioject, Inc. Needleless hypodermic injection device
US5401650A (en) 1990-10-24 1995-03-28 The Mount Sinai School Of Medicine Of The City University Of New York Cloning and expression of biologically active α-galactosidase A
WO1992013067A1 (en) * 1991-01-21 1992-08-06 Genzyme Corporation Production of enzymatically active glucocerebrosidase from recombinant cells
US6270989B1 (en) 1991-11-05 2001-08-07 Transkaryotic Therapies, Inc. Protein production and delivery
US5641670A (en) 1991-11-05 1997-06-24 Transkaryotic Therapies, Inc. Protein production and protein delivery
US5911983A (en) 1992-06-26 1999-06-15 University Of Pittsburgh Gene therapy for Gaucher disease using retroviral vectors
US5383851A (en) 1992-07-24 1995-01-24 Bioject Inc. Needleless hypodermic injection device
JPH08507677A (ja) 1992-12-10 1996-08-20 エンゾン，インコーポレーテッド 糖脂質酵素−ポリマー結合体
AU6809494A (en) 1992-12-21 1994-07-19 Enzon, Inc. Purification of proteinaceous material
DE69521074T2 (de) 1994-03-30 2001-09-13 Takara Shuzo Co., Ltd. Transglykosylierungsverfahren zur Herstellung eines Kohlenhydrats oder eines Glykokonjugates
JP3002113B2 (ja) 1994-03-30 2000-01-24 寳酒造株式会社 糖質又は複合糖質の製造方法
US5670132A (en) * 1994-09-20 1997-09-23 Immunomedics, Inc. Modified radioantibody fragments for reduced renal uptake
AU693329B2 (en) 1995-04-13 1998-06-25 Corning Incorporated Dispersion managed optical waveguide
JPH11510170A (ja) * 1995-07-27 1999-09-07 ジェネンテック インコーポレーテッド タンパク質の処方
DE69637875D1 (de) 1995-09-14 2009-04-30 Virginia Tech Intell Prop Produktion von lysosomalen enzymen in pflanzlichen expressionssystemen
JP2002504083A (ja) * 1996-03-05 2002-02-05 オーケスト インコーポレイテッド ヒアルロン酸および増殖因子による骨の増殖を促進する方法
ATE322900T1 (de) 1996-07-15 2006-04-15 Macrozyme Dnm B V Deoxynojirimycin derivate und ihre verwendung als glukosesylceramidase-inhibitoren
ES2234032T3 (es) 1996-09-13 2005-06-16 Transkaryotic Therapies, Inc. Terapia para la deficiencia de alfa-galactosidasa a.
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
JPH10273500A (ja) 1997-03-03 1998-10-13 Noguchi Inst 複合糖ペプチド及びその製造法
JPH10306099A (ja) 1997-03-04 1998-11-17 Noguchi Inst 新規複合糖ペプチドおよびその製法
TW542721B (en) * 1997-08-06 2003-07-21 Melaleuca Inc Dietary supplements containing natural ingredients
CA2299271C (en) * 1997-08-07 2009-02-03 University Of Utah Prodrugs and conjugates of thiol- and selenol- containing compounds and methods of use thereof
US5939279A (en) 1997-09-18 1999-08-17 The Board Of Trustees Of The University Of Arkansas Inhibition of bacterial binding by high-mannose oligosaccharides
KR20010033484A (ko) * 1997-12-22 2001-04-25 휴먼 게놈 사이언시즈, 인크. 각질세포 성장 인자-2 제제
GB9802249D0 (en) 1998-02-03 1998-04-01 Ciba Geigy Ag Organic compounds
GB9807464D0 (en) 1998-04-07 1998-06-10 Pharming Bv Purification of human acid µ-glucosidase
EP0976838A1 (en) 1998-05-06 2000-02-02 Rhone-Poulenc Nutrition Animale Enzymes mixture
JPH11318441A (ja) 1998-05-14 1999-11-24 Nagase & Co Ltd 超耐熱耐酸性アミロプルラナーゼ
KR19990086271A (ko) 1998-05-27 1999-12-15 손경식 면역세포의 신규한 엔도뉴클레아제 및 이를 사용한 면역보조제
CA2330242A1 (fr) 1998-06-05 1999-12-16 Aventis Pharma S.A. Polypeptides possedant une activite de type beta-secretase
AU771908C (en) 1998-12-09 2005-03-10 Phyton Holdings, Llc A method for manufacturing glycoproteins having human-type glycosylation
US6406455B1 (en) 1998-12-18 2002-06-18 Biovalve Technologies, Inc. Injection devices
GB9909066D0 (en) 1999-04-20 1999-06-16 Oxford Glycosciences Uk Ltd Therapies
WO2000076480A2 (en) 1999-06-11 2000-12-21 Eli Lilly And Company Pharmaceutical materials and methods for their preparation and use
DE60001745T2 (de) 1999-07-26 2004-03-04 G.D. Searle & Co., Chicago Verwendung von langkettigen n-alkyl derivaten von deoxynojirimycin mit glucocerebrosidase enzyme zur herstellung eines medikaments zur behandlung von mit glykolipiden akkumulation zusammenhängenden krankheiten
US6642038B1 (en) 1999-09-14 2003-11-04 Genzyme Glycobiology Research Institute, Inc. GlcNAc phosphotransferase of the lysosomal targeting pathway
US6770468B1 (en) 1999-09-14 2004-08-03 Genzyme Glycobiology Research Institute, Inc. Phosphodiester-α-GlcNAcase of the lysosomal targeting pathway
WO2001049830A2 (en) 1999-12-30 2001-07-12 Maxygen Aps Improved lysosomal enzymes and lysosomal enzyme activators
WO2001077307A2 (en) 2000-04-06 2001-10-18 Exegenics, Inc. Expression system for efficiently producing clinically effective lysosomal enzymes (glucocerebrosidase)
US20040204379A1 (en) 2000-06-19 2004-10-14 Cheng Seng H. Combination enzyme replacement, gene therapy and small molecule therapy for lysosomal storage diseases
WO2001097829A2 (en) 2000-06-19 2001-12-27 Genzyme Corporation Combination enzyme replacement, gene therapy and small molecule therapy for lysosomal storage diseases
US7138262B1 (en) 2000-08-18 2006-11-21 Shire Human Genetic Therapies, Inc. High mannose proteins and methods of making high mannose proteins
ES2574917T3 (es) 2000-11-30 2016-06-23 Valeritas, Inc. Sistemas y procedimientos de suministro y medición de fluido
BR0116803A (pt) 2001-01-18 2004-02-17 Merck Patent Gmbh Proteìnas de fusão bifuncionais com atividade de glicocerebrosidase
CN1156702C (zh) 2001-07-11 2004-07-07 上海晶泰生物技术有限公司 采用标记链霉亲和素-生物素技术的蛋白质芯片
US20030133924A1 (en) 2001-12-21 2003-07-17 Novazyme Pharmaceuticals, Inc. Highly phosphorylated acid beta-glucocerebrosidase and methods of treating gaucher's disease
AU2003251906B2 (en) * 2002-07-12 2008-12-04 Medarex, Inc. Methods and compositions for preventing oxidative degradation of proteins
US7194924B2 (en) * 2002-07-31 2007-03-27 Lockheed Martin Corporation System and method for biohazard detection using compression
US20040202666A1 (en) * 2003-01-24 2004-10-14 Immunomedics, Inc. Anti-cancer anthracycline drug-antibody conjugates
BRPI0407001A (pt) * 2003-01-31 2006-01-10 Sinai School Medicine Método para aumentar a estabilidade de uma proteìna purificada, uso de uma proteìna ligante sìtio-especìfica ativa, método para aumentar a produção de uma proteìna recombinante e composição farmacêutica
US20050265988A1 (en) 2004-03-18 2005-12-01 Byung-Kwon Choi Glycosylated glucocerebrosidase expression in fungal hosts
TW200606080A (en) * 2004-05-26 2006-02-16 Bristol Myers Squibb Co Container
US20060008415A1 (en) * 2004-06-25 2006-01-12 Protein Design Labs, Inc. Stable liquid and lyophilized formulation of proteins
SG158186A1 (en) * 2004-12-22 2010-01-29 Ambrx Inc Compositions containing, methods involving, and uses of non-natural amino acids and polypeptides
RS52459B (en) 2006-02-07 2013-02-28 Shire Human Genetic Therapies Inc. STABILIZED GLUCOCEREBROSIDASE COMPOSITIONS
ATE511645T1 (de) 2006-03-17 2011-06-15 Biomarin Pharm Inc Testverfahren zum nachweis von antikörpern gegen lysosomenenzyme
US8905801B1 (en) 2007-12-31 2014-12-09 Brp Us Inc. Marine outboard motor
ES2887552T3 (es) 2009-07-28 2021-12-23 Takeda Pharmaceuticals Co Composiciones y métodos para tratar la enfermedad de Gaucher
EP2542572B1 (en) 2010-03-02 2015-05-06 Protalix Ltd. Multimeric forms of therapeutic proteins and uses thereof
JP5383591B2 (ja) 2010-05-24 2014-01-08 日立建機株式会社 建設機械の油圧駆動装置
EP2595651B1 (en) 2010-07-19 2017-03-29 Shire Human Genetic Therapies, Inc. Mannose receptor c type 1 (mrc1) codon optimized cell line and uses thereof
JP5806015B2 (ja) 2011-06-30 2015-11-10 矢崎総業株式会社 電気接続箱

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