ES3038408T3 - Formulations with reduced degradation of polysorbate - Google Patents

Formulations with reduced degradation of polysorbate

Info

Publication number
ES3038408T3
ES3038408T3 ES16829373T ES16829373T ES3038408T3 ES 3038408 T3 ES3038408 T3 ES 3038408T3 ES 16829373 T ES16829373 T ES 16829373T ES 16829373 T ES16829373 T ES 16829373T ES 3038408 T3 ES3038408 T3 ES 3038408T3
Authority
ES
Spain
Prior art keywords
approximately
months
antibody
polysorbate
formulation
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES16829373T
Other languages
English (en)
Spanish (es)
Inventor
Brian Connolly
Lydia Hamburg
Emily HOLZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
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 F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Application granted granted Critical
Publication of ES3038408T3 publication Critical patent/ES3038408T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K47/06—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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • A61K9/10—Dispersions; Emulsions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ES16829373T 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate Active ES3038408T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562272965P 2015-12-30 2015-12-30
PCT/US2016/069046 WO2017117311A1 (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Publications (1)

Publication Number Publication Date
ES3038408T3 true ES3038408T3 (en) 2025-10-13

Family

ID=57868354

Family Applications (1)

Application Number Title Priority Date Filing Date
ES16829373T Active ES3038408T3 (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Country Status (15)

Country Link
US (3) US10525137B2 (enExample)
EP (1) EP3397287B8 (enExample)
JP (2) JP7008023B2 (enExample)
KR (2) KR102796135B1 (enExample)
CN (2) CN108472379B (enExample)
AU (2) AU2016380988B2 (enExample)
BR (1) BR112018010945A2 (enExample)
CA (1) CA3007419A1 (enExample)
ES (1) ES3038408T3 (enExample)
HR (1) HRP20250951T1 (enExample)
HU (1) HUE072357T2 (enExample)
IL (2) IL299759A (enExample)
PL (1) PL3397287T3 (enExample)
SG (1) SG11201804961UA (enExample)
WO (1) WO2017117311A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES3038408T3 (en) 2015-12-30 2025-10-13 Hoffmann La Roche Formulations with reduced degradation of polysorbate
CA3093692A1 (en) 2018-03-14 2019-09-19 Boehringer Ingelheim International Gmbh Use of anti-il-36r antibodies for treatment of generalized pustular psoriasis
EP3560945A1 (en) 2018-04-27 2019-10-30 F. Hoffmann-La Roche AG Methods for purification of polypeptides using polysorbates
BR112021015790A2 (pt) * 2019-03-05 2021-10-05 Regeneron Pharmaceuticals, Inc. Albumina de soro humano em formulações
BR112021021972A2 (pt) * 2019-05-03 2021-12-21 Hoffmann La Roche Métodos de redução de uma taxa de atividade de hidrólise enzimática, de redução do nível de uma ou mais enzimas hidrolíticas e de redução da degradação de um polissorbato, composições farmacêuticas e composições de porção de anticorpo formulada
CN114096266A (zh) 2019-06-17 2022-02-25 印塔斯制药有限公司 西曲瑞克的稳定配制品
CN114040754A (zh) * 2019-06-28 2022-02-11 基因泰克公司 用于稳定液体蛋白质制剂的组合物及方法
JP7732996B2 (ja) * 2020-03-20 2025-09-02 グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッド ポリソルベートを検出する方法
WO2023117858A1 (en) 2021-12-20 2023-06-29 Boehringer Ingelheim International Gmbh Method for determining the degree of oxidative degradation of polysorbate 20 in aqueous formulations

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