BR112023024757A2 - Método acelerado de preparação de formulações de proteínas liofilizadas - Google Patents

Método acelerado de preparação de formulações de proteínas liofilizadas

Info

Publication number
BR112023024757A2
BR112023024757A2 BR112023024757A BR112023024757A BR112023024757A2 BR 112023024757 A2 BR112023024757 A2 BR 112023024757A2 BR 112023024757 A BR112023024757 A BR 112023024757A BR 112023024757 A BR112023024757 A BR 112023024757A BR 112023024757 A2 BR112023024757 A2 BR 112023024757A2
Authority
BR
Brazil
Prior art keywords
accelerated method
protein formulations
dried protein
preparing freeze
formulations
Prior art date
Application number
BR112023024757A
Other languages
English (en)
Portuguese (pt)
Inventor
Arnold Mcauley
Jeff Mccormick
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 BR112023024757A2 publication Critical patent/BR112023024757A2/pt

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
    • A61K39/39591Stabilisation, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
BR112023024757A 2021-06-01 2022-06-01 Método acelerado de preparação de formulações de proteínas liofilizadas BR112023024757A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163195265P 2021-06-01 2021-06-01
PCT/US2022/031694 WO2022256359A1 (en) 2021-06-01 2022-06-01 Accelerated method of making lyophilized protein formualtions

Publications (1)

Publication Number Publication Date
BR112023024757A2 true BR112023024757A2 (pt) 2024-02-15

Family

ID=82100125

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112023024757A BR112023024757A2 (pt) 2021-06-01 2022-06-01 Método acelerado de preparação de formulações de proteínas liofilizadas

Country Status (14)

Country Link
US (1) US20240368254A1 (https=)
EP (1) EP4346778A1 (https=)
JP (1) JP2024521329A (https=)
KR (1) KR20240016260A (https=)
CN (1) CN117241787A (https=)
AR (1) AR126044A1 (https=)
AU (1) AU2022285665A1 (https=)
BR (1) BR112023024757A2 (https=)
CA (1) CA3217210A1 (https=)
CL (1) CL2023003443A1 (https=)
IL (1) IL307677A (https=)
MX (1) MX2023014034A (https=)
TW (1) TW202313108A (https=)
WO (1) WO2022256359A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4553432B1 (en) 2023-11-08 2026-04-29 Bachem Holding AG Drying bag and drying system
WO2025099273A1 (en) 2023-11-08 2025-05-15 Bachem Holding Ag Drying bag and drying system

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4751180A (en) 1985-03-28 1988-06-14 Chiron Corporation Expression using fused genes providing for protein product
US4935233A (en) 1985-12-02 1990-06-19 G. D. Searle And Company Covalently linked polypeptide cell modulators
ATE243754T1 (de) 1987-05-21 2003-07-15 Micromet Ag Multifunktionelle proteine mit vorbestimmter zielsetzung
EP1299419A2 (en) 2000-05-24 2003-04-09 Imclone Systems, Inc. Bispecific immunoglobulin-like antigen binding proteins and method of production
JP2008512352A (ja) 2004-07-17 2008-04-24 イムクローン システムズ インコーポレイティド 新規な四価の二重特異性抗体
CA2697922A1 (en) 2007-08-28 2009-03-12 Biogen Idec Ma Inc. Compositions that bind multiple epitopes of igf-1r
IL272513B2 (en) * 2017-09-15 2023-04-01 Amgen Inc Lyophilization process for pharmaceutical formulation of medical protein
AU2021330845A1 (en) * 2020-08-24 2023-01-19 Amgen Inc. Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine
KR20230067632A (ko) * 2020-09-14 2023-05-16 암젠 인크 동결건조된 단백질 제형의 제조 방법

Also Published As

Publication number Publication date
CA3217210A1 (en) 2022-12-08
KR20240016260A (ko) 2024-02-06
MX2023014034A (es) 2023-12-15
AU2022285665A1 (en) 2023-10-19
JP2024521329A (ja) 2024-05-31
TW202313108A (zh) 2023-04-01
US20240368254A1 (en) 2024-11-07
CL2023003443A1 (es) 2024-06-14
AR126044A1 (es) 2023-09-06
AU2022285665A9 (en) 2023-10-26
IL307677A (en) 2023-12-01
CN117241787A (zh) 2023-12-15
WO2022256359A1 (en) 2022-12-08
EP4346778A1 (en) 2024-04-10

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