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MX2019006633A - Formulaciones de anticuerpo. - Google Patents

Formulaciones de anticuerpo.

Info

Publication number
MX2019006633A
MX2019006633A MX2019006633A MX2019006633A MX2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A
Authority
MX
Mexico
Prior art keywords
formulations
antibody formulations
methods
trehalose
biotechnology
Prior art date
Application number
MX2019006633A
Other languages
English (en)
Inventor
Yatin Gokarn
Isidro E Zarraga
Jonathan Zarzar
Thomas Patapoff
Christine Wurth
Original Assignee
Genentech Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51625441&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2019006633(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of MX2019006633A publication Critical patent/MX2019006633A/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
    • 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
    • A61K47/16—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
    • A61K47/26—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
    • A61K9/08—Solutions
    • 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
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'

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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Endocrinology (AREA)

Abstract

La invención proporciona formulaciones farmacéuticas acuosas estables que comprenden un anticuerpo terapéutico, trehalosa, un amortiguador, y tensoactivo opcional, y que tienen un pH en el intervalo de aproximadamente 5.5 hasta aproximadamente 7.0. La invención también proporciona métodos para preparar esas formulaciones y métodos de uso de esas formulaciones.
MX2019006633A 2013-03-13 2015-09-02 Formulaciones de anticuerpo. MX2019006633A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201361780899P 2013-03-13 2013-03-13

Publications (1)

Publication Number Publication Date
MX2019006633A true MX2019006633A (es) 2021-12-08

Family

ID=51625441

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2015011425A MX365567B (es) 2013-03-13 2014-03-13 Formulaciones de anticuerpo.
MX2019006633A MX2019006633A (es) 2013-03-13 2015-09-02 Formulaciones de anticuerpo.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2015011425A MX365567B (es) 2013-03-13 2014-03-13 Formulaciones de anticuerpo.

Country Status (17)

Country Link
US (3) US10010611B2 (es)
EP (2) EP3744345B1 (es)
JP (2) JP6511609B2 (es)
KR (2) KR102048512B1 (es)
CN (2) CN110538322A (es)
AR (1) AR095396A1 (es)
AU (2) AU2014243783B2 (es)
BR (1) BR112015022210A8 (es)
CA (1) CA2906057A1 (es)
IL (2) IL240886B (es)
MX (2) MX365567B (es)
MY (2) MY189047A (es)
NZ (2) NZ751452A (es)
RU (2) RU2694055C2 (es)
SG (2) SG11201507475UA (es)
WO (1) WO2014160490A1 (es)
ZA (2) ZA201506981B (es)

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CN110538322A (zh) 2013-03-13 2019-12-06 豪夫迈·罗氏有限公司 抗体配制剂
EP3193932B1 (en) 2014-09-15 2023-04-26 F. Hoffmann-La Roche AG Antibody formulations
TWI705827B (zh) 2014-11-07 2020-10-01 瑞士商諾華公司 治療眼部疾病之方法
WO2016120753A1 (en) 2015-01-28 2016-08-04 Pfizer Inc. Stable aqueous anti- vascular endothelial growth factor (vegf) antibody formulation
US11149091B2 (en) * 2015-12-09 2021-10-19 Cedars-Sinai Medical Center Methods for treating nephrotic syndrome
CN105920600A (zh) * 2016-04-19 2016-09-07 上海景泽生物技术有限公司 一种稳定的抗vegf抗体制剂及其用途
MX2018016362A (es) 2016-06-27 2019-04-22 Morphosys Ag Formulaciones de anticuerpo anti-cd19.
CN107384932B (zh) 2016-08-31 2020-10-20 北京天广实生物技术股份有限公司 抗人cd20人源化单克隆抗体mil62、其制备方法及用途
EP3541413A2 (en) 2016-11-21 2019-09-25 Polpharma Biologics S.A. Aqueous pharmaceutical formulations
CN108686204A (zh) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 包含组氨酸缓冲体系的英夫利西单抗组合物
US11865175B1 (en) 2017-04-28 2024-01-09 Cedars-Sinai Medical Center Post-transplantation prophylaxis and treatments for antibody-mediated rejection of solid organ transplant
CN107899020A (zh) * 2017-08-11 2018-04-13 百奥泰生物科技(广州)有限公司 Cd20阳性疾病治疗的化合物及方法
CN107881160A (zh) * 2017-08-11 2018-04-06 百奥泰生物科技(广州)有限公司 一种由基因组被编辑的cho宿主细胞产生的具有独特糖谱的重组抗体及其制备方法
WO2019064263A1 (en) * 2017-09-29 2019-04-04 Janssen Biotech, Inc. NOVEL FORMULATIONS FOR STABILIZING LOW DOSE ANTIBODY COMPOSITIONS
JP7692699B2 (ja) * 2017-12-22 2025-06-16 サムスン バイオエピス カンパニー リミテッド Ｖｅｇｆアンタゴニストを含む液体組成物
KR102655828B1 (ko) 2018-08-16 2024-04-08 이엠디 밀리포어 코포레이션 폐쇄된 바이오프로세싱 장치
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
CN114555117A (zh) * 2019-10-12 2022-05-27 百奥泰生物制药股份有限公司 抗cd20抗体制剂及抗cd20抗体在治疗cd20阳性疾病中的应用
CN115066262B (zh) * 2020-03-04 2025-07-15 上海复宏汉霖生物技术股份有限公司 一种包含贝伐珠单抗的药物配制剂
WO2022265591A1 (en) * 2021-06-18 2022-12-22 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of bevacizumab

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