ZA201504564B - Anti her2 antibody formulation - Google Patents

Anti her2 antibody formulation

Info

Publication number
ZA201504564B
ZA201504564B ZA2015/04564A ZA201504564A ZA201504564B ZA 201504564 B ZA201504564 B ZA 201504564B ZA 2015/04564 A ZA2015/04564 A ZA 2015/04564A ZA 201504564 A ZA201504564 A ZA 201504564A ZA 201504564 B ZA201504564 B ZA 201504564B
Authority
ZA
South Africa
Prior art keywords
her2 antibody
antibody formulation
anti her2
formulation
her2
Prior art date
Application number
ZA2015/04564A
Other languages
English (en)
Inventor
Niall O'mahony Kevin
Pier-Lorenzo Giovannini Roberto
André Albanese Jonathan
Original Assignee
Glenmark Pharmaceuticals 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 Glenmark Pharmaceuticals Sa filed Critical Glenmark Pharmaceuticals Sa
Publication of ZA201504564B publication Critical patent/ZA201504564B/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
    • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
ZA2015/04564A 2012-12-21 2015-06-24 Anti her2 antibody formulation ZA201504564B (en)

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
ZA201504564B true ZA201504564B (en) 2016-11-30

Family

ID=49779926

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA2015/04564A ZA201504564B (en) 2012-12-21 2015-06-24 Anti her2 antibody formulation

Country Status (15)

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

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
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
US20210283269A1 (en) * 2018-07-25 2021-09-16 Daiichi Sankyo Company, Limited Effective method for manufacturing antibody-drug conjugate
WO2020022475A1 (ja) 2018-07-27 2020-01-30 第一三共株式会社 抗体-薬物コンジュゲートの薬物部位を認識する蛋白質
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
US20220178940A1 (en) * 2019-03-22 2022-06-09 Somalogic, Inc. Reducing Intersample Analyte Variability in Complex Biological Matrices
WO2020264300A1 (en) * 2019-06-28 2020-12-30 Genentech, Inc. Composition and methods for stabilizing liquid protein formulations
EP3999537A1 (en) * 2019-07-19 2022-05-25 Ichnos Sciences SA Lyophilized antibody formulation
MX2022010599A (es) 2020-02-28 2022-09-09 Regeneron Pharma Moleculas biespecificas de union al antigeno que se unen a her2, y metodos de uso de los mismos.
CN114504642A (zh) * 2020-11-17 2022-05-17 江苏奥赛康药业有限公司 一种含抗cldn18.2抗体的液体药物组合物
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
JP2024544923A (ja) * 2021-11-12 2024-12-05 ベックマン コールター, インコーポレイテッド ポリマー色素がコンジュゲートされた抗体の乾燥のための新規製剤
WO2023140807A1 (en) * 2022-01-19 2023-07-27 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of trastuzumab
EP4511062A1 (en) * 2022-04-22 2025-02-26 Eirgenix, Inc. Pharmaceutical compositons containing anti-her2 antibody for subcutaneous administration
WO2025085781A1 (en) 2023-10-19 2025-04-24 Genentech, Inc. Combinations of il15/il15r alpha heterodimeric fc-fusion proteins and her2xcd3 bispecific antibodies for the treatment of her2-positive cancers

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989011297A1 (en) * 1988-05-27 1989-11-30 Centocor, Inc. Freeze-dried formulation for antibody products
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
SI1516628T1 (sl) * 1995-07-27 2013-10-30 Genentech, Inc. Stabilna izotonična liofilizirana proteinska formulacija
JP3919235B2 (ja) * 1997-06-13 2007-05-23 ジェネンテク,インコーポレイテッド 抗体製剤
US7452539B2 (en) * 2001-12-19 2008-11-18 Genentech, Inc. Stabilizing polypeptides which have been exposed to urea
WO2004001007A2 (en) * 2002-06-21 2003-12-31 Idec Pharmaceuticals Corporation Buffered formulations for concentrating antibodies and methods of use thereof
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
EP2390267B1 (en) * 2005-06-07 2013-06-05 ESBATech - a Novartis Company LLC Stable and soluble antibodies inhibiting TNF(alpha)
WO2006138181A2 (en) * 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
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
CA2895869C (en) 2020-09-22
BR112015014853A2 (pt) 2017-08-22
JP2018199720A (ja) 2018-12-20
MX2019010479A (es) 2019-10-15
IL239509A0 (en) 2015-08-31
US20150343058A1 (en) 2015-12-03
EP2934582A1 (en) 2015-10-28
JP6400595B2 (ja) 2018-10-03
AU2013360812B2 (en) 2018-11-08
WO2014096051A1 (en) 2014-06-26
CA2895869A1 (en) 2014-06-26
AU2013360812A1 (en) 2015-07-09
MX2015008194A (es) 2016-02-05
EA201391729A1 (ru) 2014-09-30
WO2014096051A9 (en) 2014-10-02
PL2934582T3 (pl) 2020-08-10
DK2934582T3 (da) 2020-02-24
ES2773103T3 (es) 2020-07-09
MX367748B (es) 2019-09-04
JP2016508973A (ja) 2016-03-24
EP2934582B1 (en) 2019-11-27
HK1215796A1 (en) 2016-09-15
SG11201504897YA (en) 2015-07-30
US20200061190A1 (en) 2020-02-27

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