ES2773103T3 - Formulación de anticuerpos anti HER2 - Google Patents

Formulación de anticuerpos anti HER2 Download PDF

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Publication number
ES2773103T3
ES2773103T3 ES13808043T ES13808043T ES2773103T3 ES 2773103 T3 ES2773103 T3 ES 2773103T3 ES 13808043 T ES13808043 T ES 13808043T ES 13808043 T ES13808043 T ES 13808043T ES 2773103 T3 ES2773103 T3 ES 2773103T3
Authority
ES
Spain
Prior art keywords
formulation
her2
antibody
her2 antibody
lyophilized
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.)
Active
Application number
ES13808043T
Other languages
English (en)
Spanish (es)
Inventor
Jonathan André Albanese
Roberto Pier-Lorenzo Giovannini
Kevin Niall O'mahony
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.)
Ichnos Sciences SA
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 ES2773103T3 publication Critical patent/ES2773103T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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)
ES13808043T 2012-12-21 2013-12-18 Formulación de anticuerpos anti HER2 Active ES2773103T3 (es)

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
ES2773103T3 true ES2773103T3 (es) 2020-07-09

Family

ID=49779926

Family Applications (1)

Application Number Title Priority Date Filing Date
ES13808043T Active ES2773103T3 (es) 2012-12-21 2013-12-18 Formulación de anticuerpos anti HER2

Country Status (15)

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

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
KR20210038904A (ko) * 2018-07-25 2021-04-08 다이이찌 산쿄 가부시키가이샤 항체-약물 콘쥬게이트의 효과적인 제조 방법
US12358999B2 (en) 2018-07-27 2025-07-15 Daiichi Sankyo Company, Limited Protein recognizing drug moiety of antibody-drug conjugate
US11634485B2 (en) 2019-02-18 2023-04-25 Eli Lilly And Company Therapeutic antibody formulation
CN113508297A (zh) * 2019-03-22 2021-10-15 私募蛋白质体公司 降低复杂生物基质中样品间分析物的可变性
AU2020304649B2 (en) * 2019-06-28 2025-09-04 Genentech, Inc. Composition and methods for stabilizing liquid protein formulations
WO2021013689A1 (en) * 2019-07-19 2021-01-28 Ichnos Sciences SA Lyophilized antibody formulation
CN115175737A (zh) 2020-02-28 2022-10-11 瑞泽恩制药公司 结合her2的双特异性抗原结合分子及其使用方法
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
MX2024005772A (es) * 2021-11-12 2024-07-22 Beckman Coulter Inc Novedosa formulación para la tinción de anticuerpos conjugados con polímeros.
WO2023140807A1 (en) * 2022-01-19 2023-07-27 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of trastuzumab
JP2025513655A (ja) * 2022-04-22 2025-04-25 エルゲニックス インク 皮下投与用抗her2抗体含有医薬組成物
TW202532440A (zh) 2023-10-19 2025-08-16 美商建南德克公司 用於治療HER2陽性癌症的IL15/IL15Rα異二聚體FC融合蛋白及HER2xCD3雙特異性抗體之組合

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE68908175T2 (de) * 1988-05-27 1994-03-03 Centocor Inc Gefriergetrocknete formulierung für antikörperprodukte.
DK2275119T3 (da) * 1995-07-27 2013-11-11 Genentech Inc Stabil, isotonisk lyofiliseret proteinformulering
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP0999853B1 (en) * 1997-06-13 2003-01-02 Genentech, Inc. Stabilized antibody formulation
WO2003062375A2 (en) * 2001-12-19 2003-07-31 Genentech, Inc. Stabilizing polypeptides which have been exposed to urea
EP1551875A4 (en) * 2002-06-21 2006-06-28 Biogen Idec Inc TAMPON PREPARATIONS FOR CONCENTRATING ANTIBODIES AND METHODS FOR 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)
EP3673919A1 (en) * 2005-06-14 2020-07-01 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
MX2015008194A (es) 2016-02-05
MX2019010479A (es) 2019-10-15
PL2934582T3 (pl) 2020-08-10
WO2014096051A9 (en) 2014-10-02
JP2018199720A (ja) 2018-12-20
BR112015014853A2 (pt) 2017-08-22
WO2014096051A1 (en) 2014-06-26
JP6400595B2 (ja) 2018-10-03
AU2013360812B2 (en) 2018-11-08
CA2895869C (en) 2020-09-22
EA201391729A1 (ru) 2014-09-30
IL239509A0 (en) 2015-08-31
ZA201504564B (en) 2016-11-30
US20200061190A1 (en) 2020-02-27
EP2934582A1 (en) 2015-10-28
HK1215796A1 (en) 2016-09-15
AU2013360812A1 (en) 2015-07-09
CA2895869A1 (en) 2014-06-26
MX367748B (es) 2019-09-04
EP2934582B1 (en) 2019-11-27
DK2934582T3 (da) 2020-02-24
SG11201504897YA (en) 2015-07-30
JP2016508973A (ja) 2016-03-24
US20150343058A1 (en) 2015-12-03

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