ZA200405785B - Lyophilized preparation containing antibodies to the EGF receptor. - Google Patents

Lyophilized preparation containing antibodies to the EGF receptor. Download PDF

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Publication number
ZA200405785B
ZA200405785B ZA200405785A ZA200405785A ZA200405785B ZA 200405785 B ZA200405785 B ZA 200405785B ZA 200405785 A ZA200405785 A ZA 200405785A ZA 200405785 A ZA200405785 A ZA 200405785A ZA 200405785 B ZA200405785 B ZA 200405785B
Authority
ZA
South Africa
Prior art keywords
pharmaceutical preparation
solution
preparation according
lyophilised
antibody
Prior art date
Application number
ZA200405785A
Other languages
English (en)
Inventor
Hanns-Christian Mahler
Robert Mueller
Udo Haas
Ulrike Martini-Marr
Hans-Peter Zobel
Christiane Bachmann
Ludwig Krueger
Original Assignee
Merck Patent Gmbh
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 Merck Patent Gmbh filed Critical Merck Patent Gmbh
Publication of ZA200405785B publication Critical patent/ZA200405785B/en

Links

Classifications

    • 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
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • 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
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

Landscapes

  • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
ZA200405785A 2001-12-21 2004-07-20 Lyophilized preparation containing antibodies to the EGF receptor. ZA200405785B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE10163459A DE10163459A1 (de) 2001-12-21 2001-12-21 Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor

Publications (1)

Publication Number Publication Date
ZA200405785B true ZA200405785B (en) 2005-06-29

Family

ID=7710502

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA200405785A ZA200405785B (en) 2001-12-21 2004-07-20 Lyophilized preparation containing antibodies to the EGF receptor.

Country Status (27)

Country Link
US (2) US20050220786A1 (ko)
EP (1) EP1455824B1 (ko)
JP (1) JP2005513110A (ko)
KR (1) KR100942399B1 (ko)
CN (1) CN100515495C (ko)
AR (1) AR037971A1 (ko)
AT (1) ATE403439T1 (ko)
AU (1) AU2002358533B2 (ko)
BR (1) BR0215266A (ko)
CA (1) CA2470316A1 (ko)
CO (1) CO5590939A2 (ko)
DE (2) DE10163459A1 (ko)
EC (1) ECSP045197A (ko)
ES (1) ES2309220T3 (ko)
HK (1) HK1071306A1 (ko)
HU (1) HUP0402192A2 (ko)
IL (1) IL162588A0 (ko)
MX (1) MXPA04006059A (ko)
MY (1) MY139055A (ko)
NZ (1) NZ534211A (ko)
PE (1) PE20030777A1 (ko)
PL (1) PL205982B1 (ko)
RU (1) RU2339402C2 (ko)
TW (1) TWI318884B (ko)
UA (1) UA83461C2 (ko)
WO (1) WO2003053465A2 (ko)
ZA (1) ZA200405785B (ko)

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US7060808B1 (en) * 1995-06-07 2006-06-13 Imclone Systems Incorporated Humanized anti-EGF receptor monoclonal antibody
US20030224001A1 (en) * 1998-03-19 2003-12-04 Goldstein Neil I. Antibody and antibody fragments for inhibiting the growth of tumors
ZA200007412B (en) * 1998-05-15 2002-03-12 Imclone Systems Inc Treatment of human tumors with radiation and inhibitors of growth factor receptor tyrosine kinases.
EE200100603A (et) * 1999-05-14 2003-02-17 Imclone Systems Incorporated Inimese refraktaarsete kasvajate ravi epidermaalse kasvufaktori retseptori antagonistidega
AU9500201A (en) * 2000-08-09 2002-02-18 Imclone Systems Inc Treatment of hyperproliferative diseases with epidermal growth factor receptor antagonists
US20080008704A1 (en) * 2001-03-16 2008-01-10 Mark Rubin Methods of treating colorectal cancer with anti-epidermal growth factor antibodies
DE60237282D1 (de) * 2001-06-28 2010-09-23 Domantis Ltd Doppelspezifischer ligand und dessen verwendung
DK1517921T3 (da) * 2002-06-28 2006-10-09 Domantis Ltd Immunglobulin-enkeltvariable antigen-bindende domæner og dobbeltspecifikke konstruktioner deraf
US9321832B2 (en) * 2002-06-28 2016-04-26 Domantis Limited Ligand
US7696320B2 (en) 2004-08-24 2010-04-13 Domantis Limited Ligands that have binding specificity for VEGF and/or EGFR and methods of use therefor
CA2511910A1 (en) * 2002-12-27 2004-07-15 Domantis Limited Dual specific single domain antibodies specific for a ligand and for the receptor of the ligand
EP1622941A2 (en) * 2003-03-20 2006-02-08 ImClone Systems Incorporated Method of producing an antibody to epidermal growth factor receptor
DE10355251A1 (de) * 2003-11-26 2005-06-23 Merck Patent Gmbh Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor
DE10355904A1 (de) * 2003-11-29 2005-06-30 Merck Patent Gmbh Feste Formen von anti-EGFR-Antikörpern
CN1953768B (zh) * 2004-02-12 2010-10-13 默克专利有限公司 抗-egfr抗体的高浓缩液体制剂
EP1735348B1 (en) * 2004-03-19 2012-06-20 Imclone LLC Human anti-epidermal growth factor receptor antibody
JP2008519757A (ja) * 2004-11-12 2008-06-12 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング 抗egfr抗体の固形物
US7956160B2 (en) * 2005-07-22 2011-06-07 Amgen Inc. Concentrated protein lyophilates, methods, and uses
KR20080077238A (ko) * 2005-12-01 2008-08-21 도만티스 리미티드 인터루킨 1 수용체 타입 1에 결합하는 비경쟁적 도메인항체 포맷
WO2007076354A2 (en) * 2005-12-20 2007-07-05 Bristol-Myers Squibb Company Stable protein formulations
US9309316B2 (en) 2005-12-20 2016-04-12 Bristol-Myers Squibb Company Stable subcutaneous protein formulations and uses thereof
KR20090021298A (ko) * 2006-06-14 2009-03-02 임클론 시스템즈 인코포레이티드 항-egfr 항체의 동결건조 제제
JPWO2008029908A1 (ja) * 2006-09-07 2010-01-21 協和発酵キリン株式会社 抗体を含有する安定な凍結乾燥医薬製剤
EP2081553B1 (en) * 2006-10-06 2020-08-12 Amgen Inc. Stable antibody formulations
EP2094247B1 (en) * 2006-10-20 2022-06-29 Amgen Inc. Stable polypeptide formulations
CA2683801A1 (en) 2007-06-06 2008-12-11 Domantis Limited Polypeptides, antibody variable domains and antagonists
CN101716343A (zh) * 2008-10-09 2010-06-02 哈药集团生物工程有限公司 一种单克隆抗体的冻干制剂
EP3415162A1 (en) 2011-02-11 2018-12-19 Merck Patent GmbH Anti-alpha-v integrin antibody for the treatment of prostate cancer
MX341076B (es) * 2011-03-31 2016-08-04 Merck Sharp & Dohme Formulaciones estables de anticuerpos para el receptor humano pd-1 de meurte programada y tratamientos relacionados.
UA116189C2 (uk) 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
IN2014CN03555A (ko) 2011-10-25 2015-07-03 Onclave Therapeutics Ltd
US20190060241A1 (en) * 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
KR102471458B1 (ko) 2016-12-28 2022-11-25 제이씨알 파마 가부시키가이샤 동결건조 제제
CA3100981A1 (en) * 2018-06-01 2019-12-05 Rakuten Medical, Inc. Phthalocyanine dye conjugate compositions
CN113015747A (zh) 2018-10-19 2021-06-22 默克专利股份公司 用于治疗结肠直肠癌的阿比妥单抗

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Also Published As

Publication number Publication date
HUP0402192A2 (hu) 2005-01-28
MY139055A (en) 2009-08-28
CO5590939A2 (es) 2005-12-30
EP1455824B1 (de) 2008-08-06
WO2003053465A2 (de) 2003-07-03
US20080166346A1 (en) 2008-07-10
JP2005513110A (ja) 2005-05-12
CA2470316A1 (en) 2003-07-03
KR20040074099A (ko) 2004-08-21
HK1071306A1 (en) 2005-07-15
US20050220786A1 (en) 2005-10-06
RU2004122632A (ru) 2005-05-20
UA83461C2 (uk) 2008-07-25
AU2002358533A1 (en) 2003-07-09
CN100515495C (zh) 2009-07-22
MXPA04006059A (es) 2004-09-27
AR037971A1 (es) 2004-12-22
EP1455824A2 (de) 2004-09-15
AU2002358533B2 (en) 2009-01-15
PE20030777A1 (es) 2003-09-11
ECSP045197A (es) 2004-08-27
PL205982B1 (pl) 2010-06-30
DE10163459A1 (de) 2003-07-03
NZ534211A (en) 2006-01-27
TWI318884B (en) 2010-01-01
ES2309220T3 (es) 2008-12-16
ATE403439T1 (de) 2008-08-15
CN1606455A (zh) 2005-04-13
IL162588A0 (en) 2005-11-20
DE50212615D1 (de) 2008-09-18
PL369848A1 (en) 2005-05-02
KR100942399B1 (ko) 2010-02-17
RU2339402C2 (ru) 2008-11-27
TW200306205A (en) 2003-11-16
BR0215266A (pt) 2004-12-07
WO2003053465A3 (de) 2003-12-04

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