MX367748B - Formulación de anticuerpo anti her2. - Google Patents

Formulación de anticuerpo anti her2.

Info

Publication number
MX367748B
MX367748B MX2015008194A MX2015008194A MX367748B MX 367748 B MX367748 B MX 367748B MX 2015008194 A MX2015008194 A MX 2015008194A MX 2015008194 A MX2015008194 A MX 2015008194A MX 367748 B MX367748 B MX 367748B
Authority
MX
Mexico
Prior art keywords
her2 antibody
antibody formulation
anti her2
lyoprotectant
antibody
Prior art date
Application number
MX2015008194A
Other languages
English (en)
Other versions
MX2015008194A (es
Inventor
Jonathan André Albanese
Roberto Pier-Lorenzo Giovannini
Kevin Niall O'mahony
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 MX2015008194A publication Critical patent/MX2015008194A/es
Publication of MX367748B publication Critical patent/MX367748B/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, 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)

Abstract

Se describe una formulación farmacéutica que comprende una cantidad terapéuticamente efectiva de un anticuerpo, un regulador de pH de acetato, un lioprotector, un agente de carga y un agente tensoactivo.
MX2015008194A 2012-12-21 2013-12-18 Formulación de anticuerpo anti her2. MX367748B (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 (2)

Publication Number Publication Date
MX2015008194A MX2015008194A (es) 2016-02-05
MX367748B true MX367748B (es) 2019-09-04

Family

ID=49779926

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2015008194A MX367748B (es) 2012-12-21 2013-12-18 Formulación de anticuerpo anti her2.
MX2019010479A MX2019010479A (es) 2012-12-21 2015-06-22 Formulacion de anticuerpo anti her2.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2019010479A MX2019010479A (es) 2012-12-21 2015-06-22 Formulacion de anticuerpo anti her2.

Country Status (15)

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

Families Citing this family (15)

* 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
EP3831853A4 (en) 2018-07-27 2022-06-01 Daiichi Sankyo Company, Limited ANTIBODY-DRUG CONJUGATE PROTEIN-RECOGNIZING DRUG UNIT
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
US20220178940A1 (en) * 2019-03-22 2022-06-09 Somalogic, Inc. Reducing Intersample Analyte Variability in Complex Biological Matrices
IL289219B2 (en) 2019-06-28 2025-06-01 Genentech Inc Composition and methods for stabilizing liquid protein formulations
WO2021013689A1 (en) * 2019-07-19 2021-01-28 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.
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
WO2023086103A1 (en) * 2021-11-12 2023-05-19 Beckman Coulter, Inc. 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
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
EP0417193B1 (en) * 1988-05-27 1993-08-04 Centocor, Inc. Freeze-dried formulation for antibody products
PT1516628E (pt) * 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
DK0999853T3 (da) * 1997-06-13 2003-04-22 Genentech Inc Stabiliseret antostofformulering
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 .
JP5089582B2 (ja) * 2005-06-07 2012-12-05 エスバテック、アン アルコン バイオメディカル リサーチ ユニット、エルエルシー ＴＮＦαを阻害する安定な可溶性抗体
ES2776657T3 (es) * 2005-06-14 2020-07-31 Amgen Inc Formulaciones de proteínas autotamponantes
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
PL2934582T3 (pl) 2020-08-10
EP2934582B1 (en) 2019-11-27
ZA201504564B (en) 2016-11-30
SG11201504897YA (en) 2015-07-30
IL239509A0 (en) 2015-08-31
JP2018199720A (ja) 2018-12-20
MX2015008194A (es) 2016-02-05
HK1215796A1 (en) 2016-09-15
EA201391729A1 (ru) 2014-09-30
JP2016508973A (ja) 2016-03-24
WO2014096051A1 (en) 2014-06-26
ES2773103T3 (es) 2020-07-09
AU2013360812A1 (en) 2015-07-09
BR112015014853A2 (pt) 2017-08-22
CA2895869A1 (en) 2014-06-26
WO2014096051A9 (en) 2014-10-02
AU2013360812B2 (en) 2018-11-08
US20150343058A1 (en) 2015-12-03
MX2019010479A (es) 2019-10-15
DK2934582T3 (da) 2020-02-24
CA2895869C (en) 2020-09-22
US20200061190A1 (en) 2020-02-27
JP6400595B2 (ja) 2018-10-03
EP2934582A1 (en) 2015-10-28

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