MX2019007824A - Preparacion liofilizada. - Google Patents

Preparacion liofilizada.

Info

Publication number
MX2019007824A
MX2019007824A MX2019007824A MX2019007824A MX2019007824A MX 2019007824 A MX2019007824 A MX 2019007824A MX 2019007824 A MX2019007824 A MX 2019007824A MX 2019007824 A MX2019007824 A MX 2019007824A MX 2019007824 A MX2019007824 A MX 2019007824A
Authority
MX
Mexico
Prior art keywords
lyophilized preparation
active ingredient
fusion protein
antibody
buffer
Prior art date
Application number
MX2019007824A
Other languages
English (en)
Inventor
Yasukawa Hidehito
Yamaguchi Yuka
Okabe Shinji
Original Assignee
Japan Chem Res
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 Japan Chem Res filed Critical Japan Chem Res
Publication of MX2019007824A publication Critical patent/MX2019007824A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • 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
    • 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
    • C07K16/2881—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD71
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/33—Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies

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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Cell Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Problema. Proporcionar una composición farmacéutica que contiene una proteína de fusión que comprende un anticuerpo y una enzima lisosómica como ingrediente activo, que es suficientemente estable para permitir su distribución al mercado. Solución. Una formulación liofilizada que contiene una proteína de fusión que comprende un anticuerpo y una enzima lisosómica como ingrediente activo, y que además contiene una sal neutra, un disacárido, un surfactante no iónico y un regulador. Esta formulación liofilizada incluye por ejemplo, como ingrediente activo, una proteína de fusión que comprende un anticuerpo anti-receptor de transferrina e iduronato-2-sulfatasa humana, y que además contiene cloruro de sodio como la sal neutra, sacarosa como el disacárido, poloxámero como el surfactante no iónico y regulador de fosfato como el regulador.
MX2019007824A 2016-12-28 2017-12-28 Preparacion liofilizada. MX2019007824A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016257060 2016-12-28
PCT/JP2017/047207 WO2018124277A1 (ja) 2016-12-28 2017-12-28 凍結乾燥製剤

Publications (1)

Publication Number Publication Date
MX2019007824A true MX2019007824A (es) 2019-09-09

Family

ID=62709480

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019007824A MX2019007824A (es) 2016-12-28 2017-12-28 Preparacion liofilizada.

Country Status (10)

Country Link
US (2) US10940185B2 (es)
EP (1) EP3563863B1 (es)
JP (2) JP7042220B2 (es)
KR (1) KR102471458B1 (es)
CN (1) CN110114078B (es)
AU (1) AU2017386888A1 (es)
BR (1) BR112019013202A2 (es)
CA (1) CA3048381A1 (es)
MX (1) MX2019007824A (es)
WO (1) WO2018124277A1 (es)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5901877B2 (ja) 2007-07-27 2016-04-13 アーメイゲン・テクノロジーズ・インコーポレイテッドＡｒｍａｇｅｎ Ｔｅｃｈｎｏｌｏｇｉｅｓ， Ｉｎｃ． 中枢神経系のα−Ｌ−イデュロニダーゼ活性を増加させるための方法および組成物
CN114409783A (zh) 2015-06-24 2022-04-29 Jcr制药股份有限公司 通过血脑屏障的抗人转铁蛋白受体抗体
CN107849150B (zh) 2015-06-24 2021-12-14 Jcr制药股份有限公司 含有bdnf的融合蛋白
ES2947312T3 (es) 2016-07-01 2023-08-04 Univ Leland Stanford Junior Conjugados para la edición dirigida de la superficie celular
AR110586A1 (es) 2016-12-26 2019-04-10 Japan Chem Res Anticuerpo de receptor antitransferrina humana que penetra la barrera hematoencefálica
CN111278453A (zh) * 2017-09-07 2020-06-12 Jcr制药股份有限公司 水性药物组合物
MA50746A (fr) 2017-10-02 2020-08-12 Denali Therapeutics Inc Protéines de fusion comprenant des enzymes d'enzymothérapie substitutive
MX2020007024A (es) 2018-01-03 2020-10-28 Palleon Pharmaceuticals Inc Sialidasas humanas recombinantes, proteinas de fusion de sialidasa y metodos para usar las mismas.
US11738068B2 (en) 2018-06-25 2023-08-29 Jcr Pharmaceuticals Co., Ltd. Protein-containing aqueous liquid formulation
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.
PE20231931A1 (es) 2020-10-14 2023-12-01 Denali Therapeutics Inc Proteinas de fusion que comprenden enzimas sulfoglucosamina sulfohidrolasa y metodos de estas
AU2022245592A1 (en) * 2021-03-24 2023-10-19 Jcr Pharmaceuticals Co., Ltd. Stable aqueous pharmaceutical composition or freeze-dried pharmaceutical composition
CN117279665A (zh) * 2021-05-12 2023-12-22 Jcr制药股份有限公司 黏多糖贮积症i型的治疗用药物组合物
CN114058603B (zh) * 2021-11-26 2023-08-04 武汉瀚海新酶生物科技有限公司 一种鞘磷脂酶的冻干保护剂及制备方法
KR20230134823A (ko) * 2022-03-15 2023-09-22 주식회사 녹십자 α-갈락토시다제 A의 융합단백질을 포함하는 동결 건조 제제

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10163459A1 (de) 2001-12-21 2003-07-03 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor
AU2004210936C1 (en) 2003-02-11 2010-12-02 Takeda Pharmaceutical Company Limited Diagnosis and treatment of Multiple Sulfatase Deficiency and other using a Formylglycine Generating Enzyme (FGE)
EP1765868B1 (en) * 2004-06-07 2016-04-20 MacroGenics, Inc. Transferrin receptor antibodies
AU2006256041B2 (en) 2005-06-10 2012-03-29 Chugai Seiyaku Kabushiki Kaisha Stabilizer for protein preparation comprising meglumine and use thereof
EP1977763A4 (en) 2005-12-28 2010-06-02 Chugai Pharmaceutical Co Ltd STABILIZER PREPARATION CONTAINING ANTIBODIES
US20100158925A1 (en) 2006-06-14 2010-06-24 Meera Agarkhed Lyophilized formulations of anti-egfr antibodies
JP5901877B2 (ja) 2007-07-27 2016-04-13 アーメイゲン・テクノロジーズ・インコーポレイテッドＡｒｍａｇｅｎ Ｔｅｃｈｎｏｌｏｇｉｅｓ， Ｉｎｃ． 中枢神経系のα−Ｌ−イデュロニダーゼ活性を増加させるための方法および組成物
NZ709704A (en) 2007-11-30 2017-03-31 Abbvie Biotechnology Ltd Protein formulations and methods of making same
WO2010027766A1 (en) 2008-08-27 2010-03-11 Schering Corporation Lyophilized formulatons of engineered anti-il-23p19 antibodies
CN102271707B (zh) * 2008-10-29 2015-04-08 阿布林克斯公司 单域抗原结合性分子的制剂
JP5873003B2 (ja) 2009-03-18 2016-03-01 アーメイゲン・テクノロジーズ・インコーポレイテッドＡｒｍａｇｅｎ Ｔｅｃｈｎｏｌｏｇｉｅｓ， Ｉｎｃ． ＩｇＧデコイ受容体融合タンパク質の血液脳関門送達のための組成物および方法
RU2549986C2 (ru) 2009-09-15 2015-05-10 Канека Корпорейшн Модифицированный эритропоэтин, к которому присоединена водорастворимая длинноцепочечная молекула
IL291556B2 (en) * 2010-06-25 2024-02-01 Shire Human Genetic Therapies Methods and compositions for administration of arylsulfatase A to the central nervous system
RU2012154576A (ru) 2010-06-25 2014-07-27 Шир Хьюман Дженетик Терапис, Инк. Способы и композиции для доставки к цнс гепаран-n-сульфатазы
RU2660348C2 (ru) 2010-06-25 2018-07-05 Шир Хьюман Дженетик Терапис, Инк. Способы и композиции для доставки в цнс идуронат-2-сульфатазы
SG11201405475UA (en) 2012-03-07 2014-10-30 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha antibodies
RS57259B1 (sr) * 2012-12-24 2018-08-31 Abbvie Inc Prolaktin receptor vezujući proteini i njihova upotreba
TWI679019B (zh) 2013-04-29 2019-12-11 法商賽諾菲公司 抗ｉｌ－４／抗ｉｌ－１３之雙特異性抗體調配物
WO2015009961A1 (en) 2013-07-19 2015-01-22 Armagen Technologies, Inc. Compositions and methods related to structures that cross the blood brain barrier
US9994641B2 (en) * 2013-12-25 2018-06-12 Jcr Pharmaceuticals Co., Ltd. Anti-human transferrin receptor antibody that passes through blood-brain barrier
TW201623331A (zh) 2014-03-12 2016-07-01 普羅帝納生物科學公司 抗黑色素瘤細胞黏著分子（ｍｃａｍ）抗體類及使用彼等之相關方法
CN107849150B (zh) 2015-06-24 2021-12-14 Jcr制药股份有限公司 含有bdnf的融合蛋白
CN114409783A (zh) 2015-06-24 2022-04-29 Jcr制药股份有限公司 通过血脑屏障的抗人转铁蛋白受体抗体
AU2017222620B2 (en) 2016-02-24 2022-06-16 Biomarin Pharmaceutical Inc. Targeted therapeutic lysosomal enzyme fusion proteins, associated formulations and uses thereof

Also Published As

Publication number Publication date
EP3563863B1 (en) 2023-07-12
AU2017386888A1 (en) 2019-06-27
US20210187082A1 (en) 2021-06-24
CN110114078B (zh) 2024-01-30
BR112019013202A2 (pt) 2019-12-10
EP3563863A1 (en) 2019-11-06
JP2022078290A (ja) 2022-05-24
JPWO2018124277A1 (ja) 2019-10-31
WO2018124277A1 (ja) 2018-07-05
KR20190102012A (ko) 2019-09-02
CN110114078A (zh) 2019-08-09
JP7042220B2 (ja) 2022-03-25
KR102471458B1 (ko) 2022-11-25
US20190336586A1 (en) 2019-11-07
EP3563863A4 (en) 2020-10-14
US10940185B2 (en) 2021-03-09
CA3048381A1 (en) 2018-07-05

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