JP2009526856A - 抗体製剤 - Google Patents

抗体製剤 Download PDF

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Publication number
JP2009526856A
JP2009526856A JP2008555358A JP2008555358A JP2009526856A JP 2009526856 A JP2009526856 A JP 2009526856A JP 2008555358 A JP2008555358 A JP 2008555358A JP 2008555358 A JP2008555358 A JP 2008555358A JP 2009526856 A JP2009526856 A JP 2009526856A
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JP
Japan
Prior art keywords
formulation
antibody
buffer
imc
histidine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2008555358A
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English (en)
Japanese (ja)
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JP2009526856A5 (enExample
Inventor
ゴールドスタイン,ジョエル
スリヴァスタヴァ,アルヴィンド
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ImClone LLC
Original Assignee
ImClone LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ImClone LLC filed Critical ImClone LLC
Publication of JP2009526856A publication Critical patent/JP2009526856A/ja
Publication of JP2009526856A5 publication Critical patent/JP2009526856A5/ja
Pending legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [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 growth factors, growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

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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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2008555358A 2006-02-15 2007-02-15 抗体製剤 Pending JP2009526856A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US77410106P 2006-02-15 2006-02-15
PCT/US2007/004050 WO2007095337A2 (en) 2006-02-15 2007-02-15 Antibody formulation

Publications (2)

Publication Number Publication Date
JP2009526856A true JP2009526856A (ja) 2009-07-23
JP2009526856A5 JP2009526856A5 (enExample) 2010-01-07

Family

ID=38372139

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2008555358A Pending JP2009526856A (ja) 2006-02-15 2007-02-15 抗体製剤

Country Status (13)

Country Link
US (1) US20090306348A1 (enExample)
EP (1) EP1987067A4 (enExample)
JP (1) JP2009526856A (enExample)
KR (1) KR20080096827A (enExample)
CN (1) CN101495136A (enExample)
AU (1) AU2007215012A1 (enExample)
BR (1) BRPI0707796A2 (enExample)
CA (1) CA2642270A1 (enExample)
EA (1) EA200870264A1 (enExample)
IL (1) IL193408A0 (enExample)
MX (1) MX2008010562A (enExample)
NO (1) NO20083640L (enExample)
WO (1) WO2007095337A2 (enExample)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523705A (ja) * 2010-03-31 2013-06-17 スタビリテック リミテッド ミョウバンアジュバントおよびミョウバンアジュバント化ワクチンの保存方法
US10029007B2 (en) 2011-10-05 2018-07-24 Stabilitech Biopharma Ltd Stabilisation of polypeptides
US10206960B2 (en) 2010-03-31 2019-02-19 Stabilitech Biopharma Ltd Stabilisation of viral particles
US10716859B2 (en) 2010-03-31 2020-07-21 Stabilitech Biopharma Ltd Excipients for stabilising viral particles, polypeptides or biological material

Families Citing this family (29)

* Cited by examiner, † Cited by third party
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KR20090021298A (ko) * 2006-06-14 2009-03-02 임클론 시스템즈 인코포레이티드 항-egfr 항체의 동결건조 제제
EP2527364A1 (en) 2007-03-29 2012-11-28 Abbott Laboratories Crystalline anti-human IL-12 antibodies
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
EP3011953A1 (en) * 2008-10-29 2016-04-27 Ablynx N.V. Stabilised formulations of single domain antigen binding molecules
EP2346900A1 (en) 2008-10-29 2011-07-27 Wyeth LLC Methods for purification of single domain antigen binding molecules
WO2010146059A2 (en) 2009-06-16 2010-12-23 F. Hoffmann-La Roche Ag Biomarkers for igf-1r inhibitor therapy
WO2011029823A1 (en) 2009-09-09 2011-03-17 Novartis Ag Monoclonal antibody reactive with cd63 when expressed at the surface of degranulated mast cells
EP2483301A1 (en) 2009-10-01 2012-08-08 The United States Of America, As Represented By The Secretary, Department of Health and Human Services Anti-vascular endothelial growth factor receptor-2 chimeric antigen receptors and use of same for the treatment of cancer
JP2013543384A (ja) 2010-10-05 2013-12-05 ノバルティス アーゲー 抗−il12rベータ1抗体ならびに自己免疫性および炎症性疾患の処置おけるその使用
TWI486617B (zh) * 2010-10-21 2015-06-01 Iner Aec Executive Yuan 一種測定對鎝(Tc-99m)與錸(Re-186、Re-188)具有穩定錯合力之含硫螯合劑在凍晶劑中之含量與均一性的固態樣品分析技術
SG11201402661TA (en) * 2011-11-28 2014-08-28 Phasebio Pharmaceuticals Inc Therapeutic agents comprising insulin amino acid sequences
US9029510B2 (en) 2012-03-30 2015-05-12 Sorrento Therapeutics, Inc. Fully human antibodies that bind to VEGFR2 and methods of use thereof
EP2830663B1 (en) * 2012-03-30 2019-02-06 Sorrento Therapeutics Inc. Fully human antibodies that bind to vegfr2
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
AP2015008584A0 (en) 2013-02-08 2015-07-31 Novartis Ag Anti-il-17a antibodies and their use in treating autoimmune and inflammatory disorders
US9700485B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
GB201406569D0 (en) 2014-04-11 2014-05-28 Stabilitech Ltd Vaccine compositions
US20170291939A1 (en) 2014-06-25 2017-10-12 Novartis Ag Antibodies specific for il-17a fused to hyaluronan binding peptide tags
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
SI3370768T1 (sl) 2015-11-03 2022-04-29 Janssen Biotech, Inc. Protitelesa, ki se specifično vežejo na PD-1, in njihove uporabe
BR112018014150A2 (en) 2016-01-11 2018-12-11 Novartis Ag immunostimulating humanized monoclonal antibodies to human interleukin-2, and fusion proteins thereof
CN106188296B (zh) * 2016-07-19 2018-05-08 康融东方(广东)医药有限公司 一类抗血管内皮生长因子受体vegfr2的单克隆抗体及其编码基因和应用
GB2562241B (en) 2017-05-08 2022-04-06 Stabilitech Biopharma Ltd Vaccine compositions
EP3684332A1 (en) * 2017-09-18 2020-07-29 Amgen Inc. Vegfr-fc fusion protein formulations
US12398209B2 (en) * 2018-01-22 2025-08-26 Janssen Biotech, Inc. Methods of treating cancers with antagonistic anti-PD-1 antibodies
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.
CN110646618B (zh) * 2019-09-17 2022-11-01 广州市伊川生物科技有限公司 一种c反应蛋白测定试剂盒及其制备方法和应用
CN114980926A (zh) * 2020-02-21 2022-08-30 江苏恒瑞医药股份有限公司 一种抗il-4r抗体药物组合物及其用途
US11773160B1 (en) 2022-08-05 2023-10-03 Anaveon AG Immune-stimulating IL-2 fusion proteins

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04217630A (ja) * 1990-03-20 1992-08-07 Akzo Nv 安定化されたゴナドトロピンを含有する調製品
JP2004292455A (ja) * 2002-02-14 2004-10-21 Chugai Pharmaceut Co Ltd 抗体含有溶液製剤

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4946778A (en) * 1987-09-21 1990-08-07 Genex Corporation Single polypeptide chain binding molecules
US5270057A (en) * 1990-03-20 1993-12-14 Akzo N.V. Stabilized gonadotropin containing preparations
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
ATE454137T1 (de) * 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04217630A (ja) * 1990-03-20 1992-08-07 Akzo Nv 安定化されたゴナドトロピンを含有する調製品
JP2004292455A (ja) * 2002-02-14 2004-10-21 Chugai Pharmaceut Co Ltd 抗体含有溶液製剤

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523705A (ja) * 2010-03-31 2013-06-17 スタビリテック リミテッド ミョウバンアジュバントおよびミョウバンアジュバント化ワクチンの保存方法
US9101607B2 (en) 2010-03-31 2015-08-11 Stabilitech Ltd. Method for preserving alum adjuvants and alum-adjuvanted vaccines
US10206960B2 (en) 2010-03-31 2019-02-19 Stabilitech Biopharma Ltd Stabilisation of viral particles
US10716859B2 (en) 2010-03-31 2020-07-21 Stabilitech Biopharma Ltd Excipients for stabilising viral particles, polypeptides or biological material
US10029007B2 (en) 2011-10-05 2018-07-24 Stabilitech Biopharma Ltd Stabilisation of polypeptides

Also Published As

Publication number Publication date
IL193408A0 (en) 2011-08-01
BRPI0707796A2 (pt) 2011-05-10
KR20080096827A (ko) 2008-11-03
WO2007095337A2 (en) 2007-08-23
AU2007215012A1 (en) 2007-08-23
US20090306348A1 (en) 2009-12-10
MX2008010562A (es) 2009-03-05
CN101495136A (zh) 2009-07-29
CA2642270A1 (en) 2007-08-23
NO20083640L (no) 2008-11-17
EP1987067A2 (en) 2008-11-05
EP1987067A4 (en) 2012-01-25
EA200870264A1 (ru) 2009-02-27
WO2007095337A3 (en) 2008-11-27

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