EA201391729A1 - Состав, содержащий антитело - Google Patents

Состав, содержащий антитело

Info

Publication number
EA201391729A1
EA201391729A1 EA201391729A EA201391729A EA201391729A1 EA 201391729 A1 EA201391729 A1 EA 201391729A1 EA 201391729 A EA201391729 A EA 201391729A EA 201391729 A EA201391729 A EA 201391729A EA 201391729 A1 EA201391729 A1 EA 201391729A1
Authority
EA
Eurasian Patent Office
Prior art keywords
composition containing
containing antibody
antibody
lyoprotector
excipient
Prior art date
Application number
EA201391729A
Other languages
English (en)
Russian (ru)
Inventor
Джонатан Андре Альбанезе
Роберто Пьер-Лоренцо Джованнини
Кевин Найл О'махони
Original Assignee
Гленмарк Фармасьютикалс С.А.
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 Гленмарк Фармасьютикалс С.А. filed Critical Гленмарк Фармасьютикалс С.А.
Publication of EA201391729A1 publication Critical patent/EA201391729A1/ru

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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32Immunoglobulins [IG], 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (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)
EA201391729A 2012-12-21 2013-12-19 Состав, содержащий антитело EA201391729A1 (ru)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201261745293P 2012-12-21 2012-12-21

Publications (1)

Publication Number Publication Date
EA201391729A1 true EA201391729A1 (ru) 2014-09-30

Family

ID=49779926

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201391729A EA201391729A1 (ru) 2012-12-21 2013-12-19 Состав, содержащий антитело

Country Status (15)

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

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
SG11202100653YA (en) * 2018-07-25 2021-02-25 Daiichi Sankyo Co Ltd 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
SG11202109160UA (en) * 2019-03-22 2021-10-28 Somalogic Inc Reducing intersample analyte variability in complex biological matrices
JP2022538293A (ja) * 2019-06-28 2022-09-01 ジェネンテック, インコーポレイテッド 液体タンパク質製剤を安定化するための組成物及び方法
US20220273796A1 (en) * 2019-07-19 2022-09-01 Ichnos Sciences SA Lyophilized antibody formulation
KR20220148200A (ko) 2020-02-28 2022-11-04 리제너론 파마슈티칼스 인코포레이티드 Her2에 결합하는 이중특이적 항원 결합 분자 및 이의 사용 방법
CN114504642B (zh) * 2020-11-17 2026-03-27 江苏奥赛康生物医药有限公司 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
CA3237877A1 (en) * 2021-11-12 2023-05-19 Aditya JARARE Novel formulation for drying of polymer dye conjugated antibodies
WO2023140807A1 (en) * 2022-01-19 2023-07-27 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of trastuzumab
TWI864690B (zh) * 2022-04-22 2024-12-01 台康生技股份有限公司 用於皮下投予之包含抗-her2抗體的藥學組合物
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
DE68908175T2 (de) * 1988-05-27 1994-03-03 Centocor Inc Gefriergetrocknete formulierung für antikörperprodukte.
ES2434840T3 (es) * 1995-07-27 2013-12-17 Genentech, Inc. Formulación de proteína liofilizada isotónica estable
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
CA2635352C (en) * 1997-06-13 2012-09-11 Genentech, Inc. Stabilized antibody formulation
US7452539B2 (en) * 2001-12-19 2008-11-18 Genentech, Inc. Stabilizing polypeptides which have been exposed to urea
CN1671741A (zh) * 2002-06-21 2005-09-21 拜奥根Idec公司 浓缩抗体的缓冲剂制剂及其使用方法
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
KR101457223B1 (ko) * 2005-06-07 2014-11-04 에스바테크 - 어 노바티스 컴파니 엘엘씨 TNFα를 억제하는 안정적이고 가용성인 항체
BRPI0611901A2 (pt) * 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
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
JP6400595B2 (ja) 2018-10-03
WO2014096051A1 (en) 2014-06-26
US20200061190A1 (en) 2020-02-27
IL239509A0 (en) 2015-08-31
WO2014096051A9 (en) 2014-10-02
AU2013360812A1 (en) 2015-07-09
MX2019010479A (es) 2019-10-15
PL2934582T3 (pl) 2020-08-10
BR112015014853A2 (pt) 2017-08-22
DK2934582T3 (da) 2020-02-24
ZA201504564B (en) 2016-11-30
SG11201504897YA (en) 2015-07-30
CA2895869A1 (en) 2014-06-26
CA2895869C (en) 2020-09-22
JP2016508973A (ja) 2016-03-24
AU2013360812B2 (en) 2018-11-08
HK1215796A1 (en) 2016-09-15
MX2015008194A (es) 2016-02-05
EP2934582A1 (en) 2015-10-28
EP2934582B1 (en) 2019-11-27
US20150343058A1 (en) 2015-12-03
MX367748B (es) 2019-09-04
ES2773103T3 (es) 2020-07-09
JP2018199720A (ja) 2018-12-20

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