CR20240130A - Formulaciones de anticuerpos - Google Patents

Formulaciones de anticuerpos

Info

Publication number
CR20240130A
CR20240130A CR20240130A CR20240130A CR20240130A CR 20240130 A CR20240130 A CR 20240130A CR 20240130 A CR20240130 A CR 20240130A CR 20240130 A CR20240130 A CR 20240130A CR 20240130 A CR20240130 A CR 20240130A
Authority
CR
Costa Rica
Prior art keywords
antibody formulations
exemplary embodiments
composition comprises
liquid composition
liquid
Prior art date
Application number
CR20240130A
Other languages
English (en)
Inventor
Rulin Qian
Nicole Ball
Christopher Sloey
Alexis Lueras
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 CR20240130A publication Critical patent/CR20240130A/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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • 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
    • A61K47/26—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
    • A61K9/08—Solutions
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (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)
  • Peptides Or Proteins (AREA)

Abstract

En el presente documento se proporcionan composiciones líquidas que comprenden una concentración alta de un anticuerpo monoclonal, por ejemplo, superior a aproximadamente 100 mg/ml, que demuestran estabilidad de almacenamiento y viscosidad reducida. En realizaciones de ejemplo, la composición líquida comprende aproximadamente menos de aproximadamente 400 mM de glutamato de arginina y, en realizaciones de ejemplo alternativas, la composición líquida comprende prolina y un amortiguador.
CR20240130A 2021-08-12 2022-08-11 Formulaciones de anticuerpos CR20240130A (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
CR20240130A true CR20240130A (es) 2024-04-12

Family

ID=83151728

Family Applications (1)

Application Number Title Priority Date Filing Date
CR20240130A CR20240130A (es) 2021-08-12 2022-08-11 Formulaciones de anticuerpos

Country Status (16)

Country Link
US (1) US20240343795A1 (es)
EP (1) EP4384217A1 (es)
JP (1) JP2024532736A (es)
KR (1) KR20240046881A (es)
AU (1) AU2022325870A1 (es)
CA (1) CA3228269A1 (es)
CL (1) CL2024000401A1 (es)
CO (1) CO2024001383A2 (es)
CR (1) CR20240130A (es)
IL (1) IL310275A (es)
JO (1) JOP20240024A1 (es)
MX (1) MX2024001934A (es)
PE (1) PE20240650A1 (es)
TW (1) TW202319398A (es)
UY (1) UY39896A (es)
WO (1) WO2023018870A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026062214A1 (en) * 2024-09-19 2026-03-26 Sanofi Formulations comprising lunsekimig

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
CN109311972A (zh) 2016-06-15 2019-02-05 美国安进公司 用于治疗乳糜泻、非乳糜泻麸质敏感和难治性乳糜泻的方法和组合物
US20200087390A1 (en) * 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
ES3036143T3 (en) * 2017-04-28 2025-09-15 Amgen Inc N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
HRP20240167T1 (hr) 2017-04-28 2024-04-26 Amgen Inc. Formulacije ljudskih anti-rankl protutijela i postupci njihove upotrebe
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
JOP20240024A1 (ar) 2024-02-08
IL310275A (en) 2024-03-01
CL2024000401A1 (es) 2024-06-21
US20240343795A1 (en) 2024-10-17
JP2024532736A (ja) 2024-09-10
WO2023018870A1 (en) 2023-02-16
TW202319398A (zh) 2023-05-16
PE20240650A1 (es) 2024-04-04
CA3228269A1 (en) 2023-02-16
KR20240046881A (ko) 2024-04-11
MX2024001934A (es) 2024-03-04
UY39896A (es) 2023-02-28
CO2024001383A2 (es) 2024-03-07
AU2022325870A1 (en) 2024-02-08
EP4384217A1 (en) 2024-06-19

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