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

    • 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
    • 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
    • A61K47/26—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
    • A61K9/14—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
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • C07K2317/90—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)
  • 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 (cg-RX-API-DMAC10.html)
EP (1) EP4346778A1 (cg-RX-API-DMAC10.html)
JP (1) JP2024521329A (cg-RX-API-DMAC10.html)
KR (1) KR20240016260A (cg-RX-API-DMAC10.html)
CN (1) CN117241787A (cg-RX-API-DMAC10.html)
AR (1) AR126044A1 (cg-RX-API-DMAC10.html)
AU (1) AU2022285665A1 (cg-RX-API-DMAC10.html)
BR (1) BR112023024757A2 (cg-RX-API-DMAC10.html)
CA (1) CA3217210A1 (cg-RX-API-DMAC10.html)
CL (1) CL2023003443A1 (cg-RX-API-DMAC10.html)
IL (1) IL307677A (cg-RX-API-DMAC10.html)
MX (1) MX2023014034A (cg-RX-API-DMAC10.html)
TW (1) TW202313108A (cg-RX-API-DMAC10.html)
WO (1) WO2022256359A1 (cg-RX-API-DMAC10.html)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK4553432T3 (da) 2023-11-08 2026-06-29 Bachem Holding Ag Tørrepose og tørresystem
CN122122428A (zh) 2023-11-08 2026-05-29 巴克姆股份公司 干燥袋和干燥系统

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
JPH02500329A (ja) 1987-05-21 1990-02-08 クリエイテイブ・バイオマリキユールズ・インコーポレーテツド ターゲット化多機能蛋白質
AU2001264946A1 (en) 2000-05-24 2001-12-03 Imclone Systems Incorporated Bispecific immunoglobulin-like antigen binding proteins and method of production
EP1786918A4 (en) 2004-07-17 2009-02-11 Imclone Systems Inc NEW BISPECIFIC ANTIBODY TETRAVALENT
CA2697922A1 (en) 2007-08-28 2009-03-12 Biogen Idec Ma Inc. Compositions that bind multiple epitopes of igf-1r
HUE059339T2 (hu) * 2017-09-15 2022-11-28 Amgen Inc Eljárás terápiás fehérje liofilizált gyógyászati kiszerelésére
EP4200333A1 (en) * 2020-08-24 2023-06-28 Amgen Inc. Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine
IL299766A (en) * 2020-09-14 2023-03-01 Amgen Inc Method of making lyophilized protein formulations

Also Published As

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

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