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MX2019000177A - Formulaciones de anticuerpos. - Google Patents

Formulaciones de anticuerpos.

Info

Publication number
MX2019000177A
MX2019000177A MX2019000177A MX2019000177A MX2019000177A MX 2019000177 A MX2019000177 A MX 2019000177A MX 2019000177 A MX2019000177 A MX 2019000177A MX 2019000177 A MX2019000177 A MX 2019000177A MX 2019000177 A MX2019000177 A MX 2019000177A
Authority
MX
Mexico
Prior art keywords
antibody formulations
disclosed
high concentration
term storage
stable long
Prior art date
Application number
MX2019000177A
Other languages
English (en)
Inventor
Francis Donny
Youssef Ahmed
Korueva Stefaniya
Kirsch Martina
Original Assignee
Sanofi 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 Sanofi Sa filed Critical Sanofi Sa
Priority claimed from PCT/EP2017/066803 external-priority patent/WO2018007456A1/en
Publication of MX2019000177A publication Critical patent/MX2019000177A/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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/0012—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • 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
    • 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
    • C07K2317/94—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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

Se describen formulaciones de anticuerpos de alta concentración capaces de ser almacenadas de forma estable a largo plazo.
MX2019000177A 2016-07-05 2017-07-05 Formulaciones de anticuerpos. MX2019000177A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662358404P 2016-07-05 2016-07-05
EP16306090 2016-08-30
PCT/EP2017/066803 WO2018007456A1 (en) 2016-07-05 2017-07-05 Antibody formulations

Publications (1)

Publication Number Publication Date
MX2019000177A true MX2019000177A (es) 2019-06-20

Family

ID=59325287

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019000177A MX2019000177A (es) 2016-07-05 2017-07-05 Formulaciones de anticuerpos.

Country Status (13)

Country Link
US (2) US11207407B2 (es)
EP (2) EP3481420B1 (es)
JP (1) JP7028855B2 (es)
KR (3) KR20220137159A (es)
CN (2) CN115998858A (es)
AU (2) AU2017293103B2 (es)
BR (1) BR112019000135A2 (es)
CA (1) CA3029642A1 (es)
DK (1) DK3481420T3 (es)
ES (1) ES3051390T3 (es)
MX (1) MX2019000177A (es)
RU (1) RU2769326C2 (es)
SG (1) SG11201900043TA (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2973151C (en) 2017-06-29 2023-12-19 Daniel B. Dix Devices and methods for overfilling drug containers
IL280880B2 (en) 2018-08-27 2025-04-01 Regeneron Pharma Using Raman Spectroscopy in Downstream Purification
PH12021551916A1 (en) 2019-02-18 2022-05-23 Lilly Co Eli Therapeutic antibody formulation.
MX2022005317A (es) * 2019-11-15 2022-05-26 Hoffmann La Roche Prevencion de formacion de particulas visibles en soluciones acuosas de proteina.
WO2023010483A1 (en) * 2021-08-05 2023-02-09 Hifibio (Hk) Limited Anti-human cxcr5 antibody and uses thereof
CN115605185A (zh) * 2020-05-19 2023-01-13 豪夫迈·罗氏有限公司（Ch） 螯合剂用于防止胃肠外蛋白质溶液中形成可见颗粒的用途
EP4008345A1 (en) * 2020-12-03 2022-06-08 Hexal AG Novel formulations for antibodies
CN117004700A (zh) * 2023-10-07 2023-11-07 北京爱博生生物技术有限公司 单克隆抗体可变区基因高通量测序的方法及其所用组合物与试剂盒

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5869619A (en) 1991-12-13 1999-02-09 Xoma Corporation Modified antibody variable domains
US20060148009A1 (en) 2004-10-12 2006-07-06 Xencor, Inc. Prediction and assessment of immunogenicity
TR201807983T4 (tr) * 2007-08-29 2018-06-21 Sanofi Sa İnsanlaştırılmış anti-CXCR5 antikorları, deriveleri ve kullanımları.
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
EP4527855A3 (en) 2012-03-26 2025-06-11 Sanofi Stable igg4 based binding agent formulations
US9592289B2 (en) * 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations

Also Published As

Publication number Publication date
AU2024219890A1 (en) 2024-10-10
ES3051390T3 (en) 2025-12-29
EP3481420B1 (en) 2025-08-13
CA3029642A1 (en) 2018-01-11
AU2017293103A1 (en) 2019-02-21
KR20190027375A (ko) 2019-03-14
CN109661240B (zh) 2022-11-29
CN109661240A (zh) 2019-04-19
US11207407B2 (en) 2021-12-28
US20190255173A1 (en) 2019-08-22
AU2017293103B2 (en) 2024-08-15
US20220111048A1 (en) 2022-04-14
DK3481420T3 (da) 2025-11-03
KR20220137159A (ko) 2022-10-11
JP2019520390A (ja) 2019-07-18
BR112019000135A2 (pt) 2019-04-16
RU2019102943A3 (es) 2020-11-11
RU2769326C2 (ru) 2022-03-30
JP7028855B2 (ja) 2022-03-02
EP3481420A1 (en) 2019-05-15
CN115998858A (zh) 2023-04-25
RU2019102943A (ru) 2020-08-05
KR20240073999A (ko) 2024-05-27
KR102450280B1 (ko) 2022-10-04
SG11201900043TA (en) 2019-02-27
EP4640713A2 (en) 2025-10-29

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