PE20240650A1 - Formulaciones de anticuerpos - Google Patents

Formulaciones de anticuerpos

Info

Publication number
PE20240650A1
PE20240650A1 PE2024000233A PE2024000233A PE20240650A1 PE 20240650 A1 PE20240650 A1 PE 20240650A1 PE 2024000233 A PE2024000233 A PE 2024000233A PE 2024000233 A PE2024000233 A PE 2024000233A PE 20240650 A1 PE20240650 A1 PE 20240650A1
Authority
PE
Peru
Prior art keywords
seq
liquid composition
approximately
antibody
cdr2
Prior art date
Application number
PE2024000233A
Other languages
English (en)
Inventor
Nicole Ball
Christopher Sloey
Alexis Lueras
Rulin Qian
Original Assignee
Amgen 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
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of PE20240650A1 publication Critical patent/PE20240650A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Referido a formulaciones de anticuerpos, como composicion liquida que comprende (a) un anticuerpo anti-IL-15 a una concentracion superior a aproximadamente 100 mg/ml, (b) de 70 mM a 210 mM aproximadamente de arginina base, (c) de 80 mM a 240 aproximadamente de glutamato, y (d) un tensioactivo, en donde el pH de la composicion liquida es de aproximadamente 4.5 a aproximadamente 5.5; como alternativa dicha composicion liquida comprende prolina y otro amortiguador. En donde el anticuerpo anti-IL-15, comprende una region determinante de complementariedad (CDR) 1 de cadena pesada (HC) de la SEQ ID NO: 1, una CDR2 de HC de la SEQ ID NO: 2, una CDR3 de HC de la SEQ ID NO: 3, una region determinante de complementariedad (CDR) 1 de cadena ligera (LC) de la SEQ ID NO: 4, una CDR2 de LC de la SEQ ID NO: 5, y una CDR3 de LC de la SEQ ID NO: 6. Tambien se refiere a metodos para preparar dicha composicion liquida, y su uso para tratar una enfermedad como la enfermedad celiaca.
PE2024000233A 2021-08-12 2022-08-11 Formulaciones de anticuerpos PE20240650A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163232299P 2021-08-12 2021-08-12
US202263316604P 2022-03-04 2022-03-04
PCT/US2022/040056 WO2023018870A1 (en) 2021-08-12 2022-08-11 Antibody formulations

Publications (1)

Publication Number Publication Date
PE20240650A1 true PE20240650A1 (es) 2024-04-04

Family

ID=83151728

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2024000233A PE20240650A1 (es) 2021-08-12 2022-08-11 Formulaciones de anticuerpos

Country Status (9)

Country Link
EP (1) EP4384217A1 (es)
KR (1) KR20240046881A (es)
AU (1) AU2022325870A1 (es)
CA (1) CA3228269A1 (es)
CO (1) CO2024001383A2 (es)
IL (1) IL310275A (es)
PE (1) PE20240650A1 (es)
TW (1) TW202319398A (es)
WO (1) WO2023018870A1 (es)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201605896A (zh) 2013-08-30 2016-02-16 安美基股份有限公司 Gitr抗原結合蛋白
EP2963057A1 (en) 2014-07-02 2016-01-06 Calypso Biotech SA Antibodies to IL-15
CA3020894A1 (en) 2016-06-15 2017-12-21 Amgen Inc. Methods and compositions for the treatment of celiac disease, non-celiac gluten sensitivity, and refractory celiac disease
US20200087390A1 (en) * 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
US20200048367A1 (en) * 2017-04-28 2020-02-13 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
JOP20190255A1 (ar) 2017-04-28 2019-10-27 Amgen Inc صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها
JP2019122373A (ja) 2018-01-12 2019-07-25 アムジエン・インコーポレーテツド 抗pd−1抗体及び治療方法
WO2021079337A1 (en) * 2019-10-23 2021-04-29 Cadila Healthcare Limited Pharmaceutical formulation of anti-her2 antibody and preparation thereof

Also Published As

Publication number Publication date
TW202319398A (zh) 2023-05-16
IL310275A (en) 2024-03-01
EP4384217A1 (en) 2024-06-19
CO2024001383A2 (es) 2024-03-07
CA3228269A1 (en) 2023-02-16
AU2022325870A1 (en) 2024-02-08
WO2023018870A1 (en) 2023-02-16
KR20240046881A (ko) 2024-04-11

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