CL2023002560A1 - Formulación de anticuerpos estable - Google Patents

Formulación de anticuerpos estable

Info

Publication number
CL2023002560A1
CL2023002560A1 CL2023002560A CL2023002560A CL2023002560A1 CL 2023002560 A1 CL2023002560 A1 CL 2023002560A1 CL 2023002560 A CL2023002560 A CL 2023002560A CL 2023002560 A CL2023002560 A CL 2023002560A CL 2023002560 A1 CL2023002560 A1 CL 2023002560A1
Authority
CL
Chile
Prior art keywords
antibody
ebov
storage
present
antibody formulation
Prior art date
Application number
CL2023002560A
Other languages
English (en)
Inventor
Liu Dingjiang
Xu Long
Yuan Cao
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of CL2023002560A1 publication Critical patent/CL2023002560A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención proporciona formulaciones farmacéuticas estables que comprenden un anticuerpo humano que se une específicamente al virus del Ébola (EBOV). En ciertas modalidades, las formulaciones contienen, además de un anticuerpo anti-EBOV, un amortiguador, un aminoácido, un surfactante no iónico y un estabilizador. Las formulaciones farmacéuticas de la presente invención exhiben un grado sustancial de estabilidad de anticuerpos frente al estrés, por ejemplo, agitación durante el transporte y almacenamiento, por ejemplo, almacenamiento a temperaturas mayores que 40 °C.
CL2023002560A 2020-01-24 2023-08-30 Formulación de anticuerpos estable CL2023002560A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US202062965786P 2020-01-24 2020-01-24

Publications (1)

Publication Number Publication Date
CL2023002560A1 true CL2023002560A1 (es) 2024-03-01

Family

ID=74858743

Family Applications (2)

Application Number Title Priority Date Filing Date
CL2022001989A CL2022001989A1 (es) 2020-01-24 2022-07-22 Formulación de anticuerpos estable
CL2023002560A CL2023002560A1 (es) 2020-01-24 2023-08-30 Formulación de anticuerpos estable

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CL2022001989A CL2022001989A1 (es) 2020-01-24 2022-07-22 Formulación de anticuerpos estable

Country Status (13)

Country Link
US (1) US20210252146A1 (es)
EP (1) EP4093435A1 (es)
JP (1) JP2023511080A (es)
KR (1) KR20220131923A (es)
CN (1) CN115243718A (es)
AU (1) AU2021210942A1 (es)
BR (1) BR112022014240A2 (es)
CA (1) CA3162569A1 (es)
CL (2) CL2022001989A1 (es)
CO (1) CO2022010254A2 (es)
IL (1) IL294375A (es)
MX (1) MX2022008949A (es)
WO (1) WO2021150829A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200148750A1 (en) 2016-07-21 2020-05-14 Emory University Ebola Virus Antibodies and Binding Agents Derived Therefrom

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
AU7089600A (en) 1999-08-30 2001-03-26 U.S. Army Medical Research Institute Of Infectious Diseases Monoclonal antibodies and vaccines against epitopes on the ebola virus glycoprotein
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
US6875433B2 (en) 2002-08-23 2005-04-05 The United States Of America As Represented By The Secretary Of The Army Monoclonal antibodies and complementarity-determining regions binding to Ebola glycoprotein
WO2009094755A1 (en) 2008-02-01 2009-08-06 Her Majesty The Queen In Right Of Canada As Represented By The Minister Of Health Monoclonal antibodies for ebola and marburg viruses
AR070315A1 (es) * 2008-02-07 2010-03-31 Merck & Co Inc Anticuerpos 1b20 antagonistas de pcsk9
EP3351628B1 (en) 2008-10-24 2023-07-26 The Government of The United States of America as represented by The Secretary, Department of Health and Human Services Human ebola virus species and compositions and methods thereof
LT2691112T (lt) * 2011-03-31 2018-07-25 Merck Sharp & Dohme Corp. Stabilios antikūnų kompozicijos prieš žmogaus programuojamos mirties receptorių pd-1 ir susiję gydymo būdai
US20140227250A1 (en) * 2012-08-23 2014-08-14 Merck Sharp & Dohme Corp. Stable formulations of antibodies to tslp
TWI710573B (zh) * 2015-01-26 2020-11-21 美商再生元醫藥公司 抗伊波拉病毒醣蛋白之人類抗體
EP3618855A4 (en) * 2017-05-02 2021-02-17 Merck Sharp & Dohme Corp. STABLE FORMULATIONS OF ANTI-TIGITE ANTIBODIES ALONE AND IN COMBINATION WITH PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USING THEREOF
AU2019258330A1 (en) * 2018-04-25 2020-12-10 Medimmune Limited Formulations of human anti-PD-L1 antibodies

Also Published As

Publication number Publication date
KR20220131923A (ko) 2022-09-29
AU2021210942A1 (en) 2022-07-14
EP4093435A1 (en) 2022-11-30
WO2021150829A1 (en) 2021-07-29
US20210252146A1 (en) 2021-08-19
MX2022008949A (es) 2022-08-15
JP2023511080A (ja) 2023-03-16
BR112022014240A2 (pt) 2022-12-13
CA3162569A1 (en) 2021-07-29
CN115243718A (zh) 2022-10-25
IL294375A (en) 2022-08-01
CO2022010254A2 (es) 2022-08-09
CL2022001989A1 (es) 2023-03-31

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