JP2005523882A - 高濃度タンパク質製剤および製造の方法 - Google Patents
高濃度タンパク質製剤および製造の方法 Download PDFInfo
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- JP2005523882A JP2005523882A JP2003535713A JP2003535713A JP2005523882A JP 2005523882 A JP2005523882 A JP 2005523882A JP 2003535713 A JP2003535713 A JP 2003535713A JP 2003535713 A JP2003535713 A JP 2003535713A JP 2005523882 A JP2005523882 A JP 2005523882A
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Images
Classifications
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- 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
- A61K49/00—Preparations for testing in vivo
- A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
- A61K49/08—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
- A61K49/10—Organic compounds
- A61K49/14—Peptides, e.g. proteins
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Rheumatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Radiology & Medical Imaging (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33021301P | 2001-10-16 | 2001-10-16 | |
| PCT/US2002/032872 WO2003032907A2 (en) | 2001-10-16 | 2002-10-16 | High-concentration protein formulations and method of manufacture |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2005523882A true JP2005523882A (ja) | 2005-08-11 |
| JP2005523882A5 JP2005523882A5 (https=) | 2006-01-05 |
Family
ID=23288780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2003535713A Pending JP2005523882A (ja) | 2001-10-16 | 2002-10-16 | 高濃度タンパク質製剤および製造の方法 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US8372798B2 (https=) |
| EP (1) | EP1441748A4 (https=) |
| JP (1) | JP2005523882A (https=) |
| CN (1) | CN1604788B (https=) |
| AU (1) | AU2002335815A1 (https=) |
| BR (1) | BR0213298A (https=) |
| MX (1) | MXPA04003640A (https=) |
| WO (1) | WO2003032907A2 (https=) |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2010540589A (ja) * | 2007-10-01 | 2010-12-24 | アンスティテュ、ナショナル、ド、ラ、サント、エ、ド、ラ、ルシェルシュ、メディカル（アンセルム） | ポロキサマー・タンパク質粒子のマイクロカプセル化 |
| JP2015509542A (ja) * | 2012-03-07 | 2015-03-30 | アミカス、セラピューティックス、インコーポレイテッドＡｍｉｃｕｓ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． | ポンペ病の処置のための高濃度α−グルコシダーゼ組成物 |
| US10208299B2 (en) | 2014-09-30 | 2019-02-19 | Amicus Therapeutics, Inc. | Highly potent acid alpha-glucosidase with enhanced carbohydrates |
| US10227577B2 (en) | 2016-03-30 | 2019-03-12 | Amicus Therapeutics, Inc. | Method for selection of high M6P recombinant proteins |
| US10512676B2 (en) | 2016-03-30 | 2019-12-24 | Amicus Therapeutics, Inc. | Formulations comprising recombinant acid alpha-glucosidase |
| US10857212B2 (en) | 2015-12-30 | 2020-12-08 | Amicus Therapeutics, Inc. | Augmented acid alpha-glucosidase for the treatment of Pompe disease |
| US12246062B2 (en) | 2017-05-15 | 2025-03-11 | Amicus Therapeutics, Inc. | Recombinant human acid alpha-glucosidase |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| AU2002213441B2 (en) | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| US20050158303A1 (en) * | 2003-04-04 | 2005-07-21 | Genentech, Inc. | Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations |
| CN1798575A (zh) | 2003-04-04 | 2006-07-05 | 健泰科生物技术公司 | 高浓度抗体和蛋白制剂 |
| JP2007538048A (ja) * | 2004-05-17 | 2007-12-27 | アレス トレーディング ソシエテ アノニム | ヒドロゲル・インターフェロン製剤 |
| AR076640A1 (es) * | 2009-03-06 | 2011-06-29 | Genentech Inc | Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura |
| HUE047173T2 (hu) | 2010-03-01 | 2020-04-28 | Bayer Healthcare Llc | Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
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- 2002-10-16 WO PCT/US2002/032872 patent/WO2003032907A2/en not_active Ceased
- 2002-10-16 AU AU2002335815A patent/AU2002335815A1/en not_active Abandoned
- 2002-10-16 MX MXPA04003640A patent/MXPA04003640A/es active IP Right Grant
- 2002-10-16 US US10/271,832 patent/US8372798B2/en not_active Expired - Fee Related
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2010540589A (ja) * | 2007-10-01 | 2010-12-24 | アンスティテュ、ナショナル、ド、ラ、サント、エ、ド、ラ、ルシェルシュ、メディカル（アンセルム） | ポロキサマー・タンパク質粒子のマイクロカプセル化 |
| JP2015509542A (ja) * | 2012-03-07 | 2015-03-30 | アミカス、セラピューティックス、インコーポレイテッドＡｍｉｃｕｓ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． | ポンペ病の処置のための高濃度α−グルコシダーゼ組成物 |
| JP2018027945A (ja) * | 2012-03-07 | 2018-02-22 | アミカス セラピューティックス インコーポレイテッド | ポンペ病の処置のための高濃度α−グルコシダーゼ組成物 |
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| US10208299B2 (en) | 2014-09-30 | 2019-02-19 | Amicus Therapeutics, Inc. | Highly potent acid alpha-glucosidase with enhanced carbohydrates |
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| US10857212B2 (en) | 2015-12-30 | 2020-12-08 | Amicus Therapeutics, Inc. | Augmented acid alpha-glucosidase for the treatment of Pompe disease |
| US11278601B2 (en) | 2015-12-30 | 2022-03-22 | Amicus Therapeutics, Inc. | Augmented acid alpha-glucosidase for the treatment of Pompe disease |
| US12414985B2 (en) | 2015-12-30 | 2025-09-16 | Amicus Therapeutics, Inc. | Augmented acid alpha-glucosidase for the treatment of Pompe disease |
| US11441138B2 (en) | 2016-03-30 | 2022-09-13 | Amicus Therapeutics, Inc. | Method for selection of high M6P recombinant proteins |
| US11491211B2 (en) | 2016-03-30 | 2022-11-08 | Amicus Therapeutics, Inc. | Formulations comprising recombinant acid alpha-glucosidase |
| US10512676B2 (en) | 2016-03-30 | 2019-12-24 | Amicus Therapeutics, Inc. | Formulations comprising recombinant acid alpha-glucosidase |
| US10227577B2 (en) | 2016-03-30 | 2019-03-12 | Amicus Therapeutics, Inc. | Method for selection of high M6P recombinant proteins |
| US12246062B2 (en) | 2017-05-15 | 2025-03-11 | Amicus Therapeutics, Inc. | Recombinant human acid alpha-glucosidase |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2002335815A1 (en) | 2003-04-28 |
| US8372798B2 (en) | 2013-02-12 |
| EP1441748A4 (en) | 2007-07-11 |
| CN1604788A (zh) | 2005-04-06 |
| WO2003032907A2 (en) | 2003-04-24 |
| BR0213298A (pt) | 2006-11-07 |
| US20030092607A1 (en) | 2003-05-15 |
| WO2003032907A3 (en) | 2004-02-19 |
| CN1604788B (zh) | 2013-04-17 |
| WO2003032907A9 (en) | 2005-01-06 |
| MXPA04003640A (es) | 2005-04-11 |
| EP1441748A2 (en) | 2004-08-04 |
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