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DK2934582T3 - Anti-her2-antistofformulering - Google Patents

Anti-her2-antistofformulering Download PDF

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Publication number
DK2934582T3
DK2934582T3 DK13808043.7T DK13808043T DK2934582T3 DK 2934582 T3 DK2934582 T3 DK 2934582T3 DK 13808043 T DK13808043 T DK 13808043T DK 2934582 T3 DK2934582 T3 DK 2934582T3
Authority
DK
Denmark
Prior art keywords
her2 antibody
antibody formulation
formulation
her2
antibody
Prior art date
Application number
DK13808043.7T
Other languages
English (en)
Inventor
Jonathan André Albanese
Roberto Pier-Lorenzo Giovannini
Kevin Niall O'mahony
Original Assignee
Ichnos Sciences SA
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 Ichnos Sciences SA filed Critical Ichnos Sciences SA
Application granted granted Critical
Publication of DK2934582T3 publication Critical patent/DK2934582T3/da

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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/12Carboxylic 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
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/14Particulate 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
DK13808043.7T 2012-12-21 2013-12-18 Anti-her2-antistofformulering DK2934582T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261745293P 2012-12-21 2012-12-21
PCT/EP2013/077166 WO2014096051A1 (en) 2012-12-21 2013-12-18 Anti her2 antibody formulation

Publications (1)

Publication Number Publication Date
DK2934582T3 true DK2934582T3 (da) 2020-02-24

Family

ID=49779926

Family Applications (1)

Application Number Title Priority Date Filing Date
DK13808043.7T DK2934582T3 (da) 2012-12-21 2013-12-18 Anti-her2-antistofformulering

Country Status (16)

Country Link
US (2) US20150343058A1 (da)
EP (1) EP2934582B1 (da)
JP (2) JP6400595B2 (da)
AU (1) AU2013360812B2 (da)
BR (1) BR112015014853A2 (da)
CA (1) CA2895869C (da)
DK (1) DK2934582T3 (da)
EA (1) EA201391729A1 (da)
ES (1) ES2773103T3 (da)
HK (1) HK1215796A1 (da)
IL (1) IL239509A0 (da)
MX (2) MX367748B (da)
PL (1) PL2934582T3 (da)
SG (1) SG11201504897YA (da)
WO (1) WO2014096051A1 (da)
ZA (1) ZA201504564B (da)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101776879B1 (ko) * 2015-01-19 2017-09-08 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
GB2542391A (en) * 2015-09-17 2017-03-22 Annexin Pharmaceuticals Ab Process of manufacture
CN112566942A (zh) * 2018-07-25 2021-03-26 第一三共株式会社 用于制造抗体-药物缀合物的有效方法
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
AR119293A1 (es) 2019-06-28 2021-12-09 Genentech Inc Composición y métodos para estabilizar formulaciones líquidas de proteínas
US20220273796A1 (en) * 2019-07-19 2022-09-01 Ichnos Sciences SA Lyophilized antibody formulation
WO2021174113A1 (en) 2020-02-28 2021-09-02 Regeneron Pharmaceuticals, Inc. Bispecific antigen binding molecules that bind her2, and methods of use thereof
CN114762727A (zh) * 2021-01-15 2022-07-19 海正生物制药有限公司 一种稳定的帕妥珠单抗的药物组合物
WO2023140807A1 (en) * 2022-01-19 2023-07-27 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of trastuzumab

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03504605A (ja) * 1988-05-27 1991-10-09 セントカー・インコーポレーテツド 抗体産生物の凍結乾燥した配合物
SI2275119T1 (sl) * 1995-07-27 2013-12-31 Genentech, Inc. Stabilna izotonična liofilizirana proteinska formulacija
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
IL133220A0 (en) * 1997-06-13 2001-03-19 Genentech Inc Stabilized antibody formulation
WO2003062375A2 (en) * 2001-12-19 2003-07-31 Genentech, Inc. Stabilizing polypeptides which have been exposed to urea
CA2490423A1 (en) * 2002-06-21 2003-12-31 Biogen Idec Inc. Buffered formulations for concentrating antibodies and methods of use thereof
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
DK2390267T3 (da) * 2005-06-07 2013-08-26 Esbatech A Novartis Co Llc Stabile og opløselige antistoffer, der hæmmer TNF(alfa)
MX2007015476A (es) * 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof

Also Published As

Publication number Publication date
CA2895869A1 (en) 2014-06-26
WO2014096051A9 (en) 2014-10-02
WO2014096051A1 (en) 2014-06-26
MX367748B (es) 2019-09-04
AU2013360812A1 (en) 2015-07-09
HK1215796A1 (zh) 2016-09-15
EP2934582B1 (en) 2019-11-27
ES2773103T3 (es) 2020-07-09
MX2015008194A (es) 2016-02-05
PL2934582T3 (pl) 2020-08-10
US20200061190A1 (en) 2020-02-27
SG11201504897YA (en) 2015-07-30
CA2895869C (en) 2020-09-22
EP2934582A1 (en) 2015-10-28
US20150343058A1 (en) 2015-12-03
JP6400595B2 (ja) 2018-10-03
ZA201504564B (en) 2016-11-30
AU2013360812B2 (en) 2018-11-08
JP2018199720A (ja) 2018-12-20
EA201391729A1 (ru) 2014-09-30
MX2019010479A (es) 2019-10-15
JP2016508973A (ja) 2016-03-24
BR112015014853A2 (pt) 2017-08-22
IL239509A0 (en) 2015-08-31

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