BR0213298A - formulações com alta concentração de proteìna e processo de fabricação - Google Patents
formulações com alta concentração de proteìna e processo de fabricaçãoInfo
- Publication number
- BR0213298A BR0213298A BRPI0213298-2A BR0213298A BR0213298A BR 0213298 A BR0213298 A BR 0213298A BR 0213298 A BR0213298 A BR 0213298A BR 0213298 A BR0213298 A BR 0213298A
- Authority
- BR
- Brazil
- Prior art keywords
- concentrated mixture
- manufacturing process
- high protein
- protein formulations
- protein
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 7
- 102000004169 proteins and genes Human genes 0.000 title abstract 5
- 108090000623 proteins and genes Proteins 0.000 title abstract 5
- 238000004519 manufacturing process Methods 0.000 title abstract 4
- 238000009472 formulation Methods 0.000 title 1
- 239000007788 liquid Substances 0.000 abstract 2
- 229920000249 biocompatible polymer Polymers 0.000 abstract 1
- 239000012141 concentrate Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 238000000710 polymer precipitation Methods 0.000 abstract 1
- 238000001556 precipitation Methods 0.000 abstract 1
Classifications
-
- 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
-
- 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
-
- 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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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 (1)
| Publication Number | Publication Date |
|---|---|
| BR0213298A true BR0213298A (pt) | 2006-11-07 |
Family
ID=23288780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0213298-2A BR0213298A (pt) | 2001-10-16 | 2002-10-16 | formulações com alta concentração de proteìna e processo de fabricação |
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=) |
Families Citing this family (20)
| 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 |
| EP2044934A1 (en) * | 2007-10-01 | 2009-04-08 | Institut National De La Sante Et De La Recherche Medicale (Inserm) | Dispersion of poloxamer-protein particles, methods of manufacturing and uses thereof |
| 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 |
| KR20200032244A (ko) * | 2012-03-07 | 2020-03-25 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 폼페병의 치료를 위한 고농도 알파-글루코시다제 조성물 |
| 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 |
| WO2015196091A1 (en) | 2014-06-20 | 2015-12-23 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
| US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
| US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
| WO2016054231A1 (en) | 2014-09-30 | 2016-04-07 | Amicus Therapeutics, Inc. | Highly potent acid alpha-glucosidase with enhanced carbohydrates |
| KR102510941B1 (ko) | 2015-12-30 | 2023-03-20 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 폼페병 치료용의 강화된 산 알파-글루코시다제 |
| US10227577B2 (en) | 2016-03-30 | 2019-03-12 | Amicus Therapeutics, Inc. | Method for selection of high M6P recombinant proteins |
| IL325155A (en) | 2016-03-30 | 2026-02-01 | Amicus Therapeutics Inc | Formulations containing recombinant acid alpha-glucosidase |
| EP3624831B1 (en) | 2017-05-15 | 2023-03-29 | Amicus Therapeutics, Inc. | Recombinant human acid alpha-glucosidase |
| WO2021042090A2 (en) * | 2020-11-27 | 2021-03-04 | Schott Ag | System for long time storage of pharmaceutical compositions at low temperatures |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AT359641B (de) * | 1978-09-19 | 1980-11-25 | Immuno Ag | Verfahren zur herstellung eines intravenoes ver- abreichbaren antikoerperhaeltigen immunglobulin- praeparates |
| PT682524E (pt) * | 1993-02-02 | 2002-03-28 | Xoma Technology Ltd | Composicoes farmaceuticas que contem a proteina bactericida indutora da permeabilidade e um agente tensioactivo |
| US5861158A (en) * | 1993-11-17 | 1999-01-19 | The United States Of America As Represented By The Deptartment Of Health And Human Services | Method and composition for transfer of active tumor-specific immunization from an immunized allogeneic bone marrow donor |
| AU692506B2 (en) * | 1993-11-17 | 1998-06-11 | Ibah, Inc. | Transparent liquid for encapsulated drug delivery |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| US5702717A (en) * | 1995-10-25 | 1997-12-30 | Macromed, Inc. | Thermosensitive biodegradable polymers based on poly(ether-ester)block copolymers |
| US20050019325A1 (en) * | 1996-01-08 | 2005-01-27 | Carter Paul J. | WSX receptor agonist antibodies |
| US5861174A (en) * | 1996-07-12 | 1999-01-19 | University Technology Corporation | Temperature sensitive gel for sustained delivery of protein drugs |
| US6228360B1 (en) * | 1998-08-19 | 2001-05-08 | Ajinomoto Co., Inc. | Antithrombotic agent and humanized anti-von Willebrand factor monoclonal antibody |
| BR0111948A (pt) * | 2000-06-26 | 2004-08-24 | Rxkinetix Inc | Composição para entrega de fator de crescimento hematopoiético |
| US6613907B2 (en) * | 2000-11-08 | 2003-09-02 | Amr Technology, Inc. | Process for the production of piperidine derivatives with microorganisms |
-
2002
- 2002-10-16 CN CN028251857A patent/CN1604788B/zh not_active Expired - Fee Related
- 2002-10-16 EP EP02770580A patent/EP1441748A4/en not_active Withdrawn
- 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
- 2002-10-16 BR BRPI0213298-2A patent/BR0213298A/pt not_active Application Discontinuation
- 2002-10-16 JP JP2003535713A patent/JP2005523882A/ja active Pending
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 |
| US20030092607A1 (en) | 2003-05-15 |
| WO2003032907A3 (en) | 2004-02-19 |
| CN1604788B (zh) | 2013-04-17 |
| JP2005523882A (ja) | 2005-08-11 |
| WO2003032907A9 (en) | 2005-01-06 |
| MXPA04003640A (es) | 2005-04-11 |
| EP1441748A2 (en) | 2004-08-04 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
| B11B | Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements |