JP2010512356A - 非経口aベータ抗体製剤 - Google Patents

非経口aベータ抗体製剤 Download PDF

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Publication number
JP2010512356A
JP2010512356A JP2009540650A JP2009540650A JP2010512356A JP 2010512356 A JP2010512356 A JP 2010512356A JP 2009540650 A JP2009540650 A JP 2009540650A JP 2009540650 A JP2009540650 A JP 2009540650A JP 2010512356 A JP2010512356 A JP 2010512356A
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JP
Japan
Prior art keywords
formulation
histidine
tween
abeta antibody
antibody
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.)
Withdrawn
Application number
JP2009540650A
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English (en)
Japanese (ja)
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JP2010512356A5 (https=
Inventor
ゴルドバッハ,ピエール
マーラー,ハンス−クリスチャン
ミュラー,ロベルト
ヴルト,クリスティーネ
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39190366&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP2010512356(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Publication of JP2010512356A publication Critical patent/JP2010512356A/ja
Publication of JP2010512356A5 publication Critical patent/JP2010512356A5/ja
Withdrawn legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2009540650A 2006-12-11 2007-12-11 非経口aベータ抗体製剤 Withdrawn JP2010512356A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06025590 2006-12-11
PCT/EP2007/010825 WO2008071394A1 (en) 2006-12-11 2007-12-11 Abeta antibody parenteral formulation

Publications (2)

Publication Number Publication Date
JP2010512356A true JP2010512356A (ja) 2010-04-22
JP2010512356A5 JP2010512356A5 (https=) 2011-02-03

Family

ID=39190366

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2009540650A Withdrawn JP2010512356A (ja) 2006-12-11 2007-12-11 非経口aベータ抗体製剤

Country Status (21)

Country Link
US (1) US20110070225A1 (https=)
EP (1) EP2094729A1 (https=)
JP (1) JP2010512356A (https=)
KR (1) KR20090104017A (https=)
CN (1) CN101553504A (https=)
AR (1) AR064220A1 (https=)
AU (1) AU2007331712A1 (https=)
BR (1) BRPI0721097A2 (https=)
CA (1) CA2671968A1 (https=)
CL (1) CL2007003583A1 (https=)
CR (1) CR10823A (https=)
EC (1) ECSP099403A (https=)
IL (1) IL198963A0 (https=)
MA (1) MA30975B1 (https=)
MX (1) MX2009006199A (https=)
NO (1) NO20092586L (https=)
PE (1) PE20081477A1 (https=)
RU (1) RU2009126420A (https=)
TW (1) TW200831133A (https=)
WO (1) WO2008071394A1 (https=)
ZA (1) ZA200904014B (https=)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015510871A (ja) * 2012-03-08 2015-04-13 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft Aβ抗体製剤
JP2015514090A (ja) * 2012-03-26 2015-05-18 サノフイ 安定なIgG4に基づく結合剤の製剤
WO2016080367A1 (ja) * 2014-11-18 2016-05-26 塩野義製薬株式会社 安定化されたペプチド組成物
JP2020158527A (ja) * 2015-08-19 2020-10-01 アストラゼネカ・アクチエボラーグAstrazeneca Aktiebolag 安定な抗ifnar1製剤

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US20160279239A1 (en) 2011-05-02 2016-09-29 Immunomedics, Inc. Subcutaneous administration of anti-cd74 antibody for systemic lupus erythematosus and autoimmune disease
US8658773B2 (en) 2011-05-02 2014-02-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
DE10303974A1 (de) 2003-01-31 2004-08-05 Abbott Gmbh & Co. Kg Amyloid-β(1-42)-Oligomere, Verfahren zu deren Herstellung und deren Verwendung
TW200530269A (en) 2003-12-12 2005-09-16 Chugai Pharmaceutical Co Ltd Anti-Mpl antibodies
US20160355591A1 (en) 2011-05-02 2016-12-08 Immunomedics, Inc. Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies
JP5057967B2 (ja) 2005-03-31 2012-10-24 中外製薬株式会社 sc(Fv)2構造異性体
CA2611726C (en) 2005-06-10 2017-07-11 Chugai Seiyaku Kabushiki Kaisha Pharmaceutical compositions containing sc(fv)2
US8691224B2 (en) 2005-11-30 2014-04-08 Abbvie Inc. Anti-Aβ globulomer 5F7 antibodies
HRP20140240T4 (hr) 2005-11-30 2017-02-24 Abbvie Inc. Monoklonalna antitijela protiv amiloidnih beta proteina i njihova upotreba
MY155286A (en) * 2005-12-12 2015-09-30 Hoffmann La Roche Antibodies against amyloid beta 4 with glycosylated in the variable region
US8455626B2 (en) 2006-11-30 2013-06-04 Abbott Laboratories Aβ conformer selective anti-aβ globulomer monoclonal antibodies
US8895004B2 (en) 2007-02-27 2014-11-25 AbbVie Deutschland GmbH & Co. KG Method for the treatment of amyloidoses
US8613923B2 (en) 2007-06-12 2013-12-24 Ac Immune S.A. Monoclonal antibody
US8048420B2 (en) 2007-06-12 2011-11-01 Ac Immune S.A. Monoclonal antibody
AU2008311367B2 (en) 2007-10-05 2014-11-13 Ac Immune S.A. Use of anti-amyloid beta antibody in ocular diseases
WO2009113083A1 (en) 2008-03-14 2009-09-17 Biocon Limited A monoclonal antibody and a method thereof
WO2009155513A2 (en) * 2008-06-20 2009-12-23 Novartis Ag Immunoglobulins with reduced aggregation
ES2531385T3 (es) * 2008-09-19 2015-03-13 Hoffmann La Roche Formulación que comprende un anticuerpo contra la selectina P
BRPI0919879A2 (pt) 2008-10-29 2016-02-16 Wyeth Llc métodos para purificação de moléculas de ligação a antígeno de domínio único
CA2738243C (en) 2008-10-29 2020-09-29 Wyeth Llc Formulations of single domain antigen binding molecules
MX2011005051A (es) * 2008-11-17 2011-06-01 Genentech Inc Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas.
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
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EP2501408B1 (en) * 2009-11-20 2020-05-27 Biocon Limited Formulations of antibody
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RU2012153786A (ru) 2010-05-28 2014-07-10 Ново Нордиск А/С Стабильные многодозовые композиции, содержащие антитело и консервант
EP2598882B1 (en) 2010-07-30 2017-07-26 AC Immune S.A. Safe and functional humanized antibodies for use in treating an amyloidosis
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CN107233569B (zh) 2011-10-25 2021-08-31 普罗西纳生物科学有限公司 抗体制剂和方法
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TWI873952B (zh) 2015-10-02 2025-02-21 瑞士商赫孚孟拉羅股份公司 雙特異性抗‐人類cd20/人類轉鐵蛋白受體抗體及使用方法
CN106620691B (zh) * 2015-11-04 2020-08-21 信达生物制药(苏州)有限公司 一种重组全人源抗ctla-4单克隆抗体制剂及其应用
CN115400220A (zh) 2015-12-30 2022-11-29 豪夫迈·罗氏有限公司 减少聚山梨酯降解的制剂
CN106199007B (zh) * 2016-08-03 2017-04-05 烟台普罗吉生物科技发展有限公司 蛋白保护剂
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015510871A (ja) * 2012-03-08 2015-04-13 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft Aβ抗体製剤
JP2015514090A (ja) * 2012-03-26 2015-05-18 サノフイ 安定なIgG4に基づく結合剤の製剤
WO2016080367A1 (ja) * 2014-11-18 2016-05-26 塩野義製薬株式会社 安定化されたペプチド組成物
JPWO2016080367A1 (ja) * 2014-11-18 2017-08-24 塩野義製薬株式会社 安定化されたペプチド組成物
JP2020158527A (ja) * 2015-08-19 2020-10-01 アストラゼネカ・アクチエボラーグAstrazeneca Aktiebolag 安定な抗ifnar1製剤
JP7035119B2 (ja) 2015-08-19 2022-03-14 アストラゼネカ・アクチエボラーグ 安定な抗ifnar1製剤
JP2022066345A (ja) * 2015-08-19 2022-04-28 アストラゼネカ・アクチエボラーグ 安定な抗ifnar1製剤

Also Published As

Publication number Publication date
WO2008071394A1 (en) 2008-06-19
NO20092586L (no) 2009-07-17
MA30975B1 (fr) 2009-12-01
EP2094729A1 (en) 2009-09-02
CA2671968A1 (en) 2008-06-19
CN101553504A (zh) 2009-10-07
ZA200904014B (en) 2010-04-28
RU2009126420A (ru) 2011-01-20
CR10823A (es) 2009-08-12
MX2009006199A (es) 2009-06-22
IL198963A0 (en) 2011-08-01
TW200831133A (en) 2008-08-01
AR064220A1 (es) 2009-03-18
AU2007331712A2 (en) 2009-07-30
AU2007331712A1 (en) 2008-06-19
ECSP099403A (es) 2009-07-31
BRPI0721097A2 (pt) 2014-07-01
PE20081477A1 (es) 2008-10-18
CL2007003583A1 (es) 2008-07-18
KR20090104017A (ko) 2009-10-05
US20110070225A1 (en) 2011-03-24

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