JP4728948B2 - 免疫グロブリン製剤およびその調製の方法 - Google Patents

免疫グロブリン製剤およびその調製の方法 Download PDF

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Publication number
JP4728948B2
JP4728948B2 JP2006503453A JP2006503453A JP4728948B2 JP 4728948 B2 JP4728948 B2 JP 4728948B2 JP 2006503453 A JP2006503453 A JP 2006503453A JP 2006503453 A JP2006503453 A JP 2006503453A JP 4728948 B2 JP4728948 B2 JP 4728948B2
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formulation
polysorbate
natalizumab
amount
present
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Expired - Lifetime
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Japanese (ja)
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JP2006517233A (ja
Inventor
デイヴィッド， ジェイ． バ−ク，
ショーン， イー． バックレー，
シャーウッド， ロス リーマン，
バーバラ， ホーゼイ オコナー，
ジェームス キャラウェイ，
フィリップス クリストファー，
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エラン ファーマシューティカルズ，インコーポレイテッド
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    • 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
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Rheumatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Nutrition Science (AREA)
  • Pain & Pain Management (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2006503453A 2003-02-10 2004-02-09 免疫グロブリン製剤およびその調製の方法 Expired - Lifetime JP4728948B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US44581803P 2003-02-10 2003-02-10
US60/445,818 2003-02-10
PCT/US2004/003873 WO2004071439A2 (en) 2003-02-10 2004-02-09 Immunoglobulin formulation and method of preparation thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2010277365A Division JP2011088913A (ja) 2003-02-10 2010-12-13 免疫グロブリン製剤およびその調製の方法

Publications (2)

Publication Number Publication Date
JP2006517233A JP2006517233A (ja) 2006-07-20
JP4728948B2 true JP4728948B2 (ja) 2011-07-20

Family

ID=32869424

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JP2006503453A Expired - Lifetime JP4728948B2 (ja) 2003-02-10 2004-02-09 免疫グロブリン製剤およびその調製の方法
JP2010277365A Pending JP2011088913A (ja) 2003-02-10 2010-12-13 免疫グロブリン製剤およびその調製の方法
JP2013192276A Withdrawn JP2014028831A (ja) 2003-02-10 2013-09-17 免疫グロブリン製剤およびその調製の方法

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JP2010277365A Pending JP2011088913A (ja) 2003-02-10 2010-12-13 免疫グロブリン製剤およびその調製の方法
JP2013192276A Withdrawn JP2014028831A (ja) 2003-02-10 2013-09-17 免疫グロブリン製剤およびその調製の方法

Country Status (28)

Country Link
US (7) US20050053598A1 (cg-RX-API-DMAC7.html)
EP (4) EP3777880A1 (cg-RX-API-DMAC7.html)
JP (3) JP4728948B2 (cg-RX-API-DMAC7.html)
KR (1) KR20050110628A (cg-RX-API-DMAC7.html)
CN (2) CN103040732B (cg-RX-API-DMAC7.html)
AR (1) AR043144A1 (cg-RX-API-DMAC7.html)
AU (2) AU2004210679A1 (cg-RX-API-DMAC7.html)
CA (1) CA2515444C (cg-RX-API-DMAC7.html)
CL (1) CL2004000224A1 (cg-RX-API-DMAC7.html)
CY (2) CY1120574T1 (cg-RX-API-DMAC7.html)
DK (2) DK3417875T3 (cg-RX-API-DMAC7.html)
ES (1) ES2819011T3 (cg-RX-API-DMAC7.html)
HU (1) HUE051878T2 (cg-RX-API-DMAC7.html)
IL (1) IL170008A (cg-RX-API-DMAC7.html)
MX (1) MXPA05008409A (cg-RX-API-DMAC7.html)
MY (1) MY162623A (cg-RX-API-DMAC7.html)
NO (1) NO346070B1 (cg-RX-API-DMAC7.html)
PE (1) PE20050190A1 (cg-RX-API-DMAC7.html)
PT (2) PT2236154T (cg-RX-API-DMAC7.html)
RU (1) RU2358763C2 (cg-RX-API-DMAC7.html)
SI (2) SI3417875T1 (cg-RX-API-DMAC7.html)
SK (1) SK50672005A3 (cg-RX-API-DMAC7.html)
TR (1) TR201808801T4 (cg-RX-API-DMAC7.html)
TW (1) TWI367766B (cg-RX-API-DMAC7.html)
UA (1) UA82685C2 (cg-RX-API-DMAC7.html)
UY (1) UY28184A1 (cg-RX-API-DMAC7.html)
WO (1) WO2004071439A2 (cg-RX-API-DMAC7.html)
ZA (1) ZA200506159B (cg-RX-API-DMAC7.html)

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* Cited by examiner, † Cited by third party
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