WO2003009817B1 - Stable lyophilized pharmaceutical formulation of igg antibodies - Google Patents
Stable lyophilized pharmaceutical formulation of igg antibodiesInfo
- Publication number
- WO2003009817B1 WO2003009817B1 PCT/US2002/024078 US0224078W WO03009817B1 WO 2003009817 B1 WO2003009817 B1 WO 2003009817B1 US 0224078 W US0224078 W US 0224078W WO 03009817 B1 WO03009817 B1 WO 03009817B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- formulation
- stable
- lyophilized formulation
- igg antibody
- stable lyophilized
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- 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
- 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
-
- 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
- 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
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
Abstract
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2454587A CA2454587C (en) | 2001-07-25 | 2002-07-25 | Stable lyophilized pharmaceutical formulation of igg antibodies |
EP02759206A EP1409018B1 (en) | 2001-07-25 | 2002-07-25 | Stable lyophilized pharmaceutical formulation the igg antibody daclizumab |
AU2002324556A AU2002324556A1 (en) | 2001-07-25 | 2002-07-25 | Stable lyophilized pharmaceutical formulation of igg antibodies |
JP2003515210A JP4317010B2 (en) | 2001-07-25 | 2002-07-25 | Stable lyophilized pharmaceutical formulation of IgG antibody |
AT02759206T ATE454137T1 (en) | 2001-07-25 | 2002-07-25 | STABLE LYOPHILIZED PHARMACEUTICAL FORMULATION OF THE IGG ANTIBODY DACLIZUMAB |
DE60235013T DE60235013D1 (en) | 2001-07-25 | 2002-07-25 | STABLE LYOPHILIZED PHARMACEUTICAL FORMULATION OF THE IGG ANTIBODY DACLIZUMAB |
MXPA04000747A MXPA04000747A (en) | 2001-07-25 | 2002-07-25 | Stable lyophilized pharmaceutical formulation of igg antibodies. |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US30787801P | 2001-07-25 | 2001-07-25 | |
US60/307,878 | 2001-07-25 |
Publications (4)
Publication Number | Publication Date |
---|---|
WO2003009817A2 WO2003009817A2 (en) | 2003-02-06 |
WO2003009817A3 WO2003009817A3 (en) | 2003-11-27 |
WO2003009817B1 true WO2003009817B1 (en) | 2003-12-18 |
WO2003009817A9 WO2003009817A9 (en) | 2004-05-06 |
Family
ID=23191544
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2002/024078 WO2003009817A2 (en) | 2001-07-25 | 2002-07-25 | Stable lyophilized pharmaceutical formulation of igg antibodies |
Country Status (10)
Country | Link |
---|---|
US (3) | US20030113316A1 (en) |
EP (1) | EP1409018B1 (en) |
JP (1) | JP4317010B2 (en) |
AT (1) | ATE454137T1 (en) |
AU (1) | AU2002324556A1 (en) |
CA (1) | CA2454587C (en) |
DE (1) | DE60235013D1 (en) |
ES (1) | ES2338218T3 (en) |
MX (1) | MXPA04000747A (en) |
WO (1) | WO2003009817A2 (en) |
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US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
US8911741B2 (en) | 2002-08-16 | 2014-12-16 | Abbvie Biotechnology Ltd. | Formulation of human antibodies for treating TNF-alpha associated disorders |
US9017671B2 (en) | 2004-10-20 | 2015-04-28 | Genentech, Inc. | Method of treating cancer with a pharmaceutical formulation comprising a HER2 antibody |
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EP1409018B1 (en) | 2010-01-06 |
WO2003009817A3 (en) | 2003-11-27 |
WO2003009817A9 (en) | 2004-05-06 |
ATE454137T1 (en) | 2010-01-15 |
WO2003009817A2 (en) | 2003-02-06 |
JP2004538287A (en) | 2004-12-24 |
US20100055097A1 (en) | 2010-03-04 |
MXPA04000747A (en) | 2004-07-08 |
EP1409018A2 (en) | 2004-04-21 |
JP4317010B2 (en) | 2009-08-19 |
US20030113316A1 (en) | 2003-06-19 |
US7592004B2 (en) | 2009-09-22 |
AU2002324556A1 (en) | 2003-02-17 |
US20060029599A1 (en) | 2006-02-09 |
CA2454587C (en) | 2012-11-13 |
US8298530B2 (en) | 2012-10-30 |
ES2338218T3 (en) | 2010-05-05 |
EP1409018A4 (en) | 2007-03-28 |
CA2454587A1 (en) | 2003-02-06 |
DE60235013D1 (en) | 2010-02-25 |
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