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MX2023014034A - Metodo acelerado para elaborar formulaciones de proteinas liofilizadas. - Google Patents

Metodo acelerado para elaborar formulaciones de proteinas liofilizadas.

Info

Publication number
MX2023014034A
MX2023014034A MX2023014034A MX2023014034A MX2023014034A MX 2023014034 A MX2023014034 A MX 2023014034A MX 2023014034 A MX2023014034 A MX 2023014034A MX 2023014034 A MX2023014034 A MX 2023014034A MX 2023014034 A MX2023014034 A MX 2023014034A
Authority
MX
Mexico
Prior art keywords
formualtions
accelerated method
lyophilized protein
making lyophilized
protein
Prior art date
Application number
MX2023014034A
Other languages
English (en)
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 MX2023014034A publication Critical patent/MX2023014034A/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
    • A61K39/39591—Stabilisation, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], 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)

Abstract

En el presente documento se desvelan métodos acelerados para preparar formulaciones liofilizadas que comprenden una proteína, tal como un anticuerpo o una molécula de unión a antígeno biespecífica, que presentan estabilidad de almacenamiento mejorada.
MX2023014034A 2021-06-01 2022-06-01 Metodo acelerado para elaborar formulaciones de proteinas liofilizadas. MX2023014034A (es)

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
MX2023014034A true MX2023014034A (es) 2023-12-15

Family

ID=82100125

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2023014034A MX2023014034A (es) 2021-06-01 2022-06-01 Metodo acelerado para elaborar formulaciones de proteinas liofilizadas.

Country Status (14)

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025099273A1 (en) 2023-11-08 2025-05-15 Bachem Holding Ag Drying bag and drying system
EP4553432A1 (en) 2023-11-08 2025-05-14 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
WO1988009344A1 (en) 1987-05-21 1988-12-01 Creative Biomolecules, Inc. Targeted multifunctional proteins
EP1299419A2 (en) 2000-05-24 2003-04-09 Imclone Systems, Inc. Bispecific immunoglobulin-like antigen binding proteins and method of production
WO2006020258A2 (en) 2004-07-17 2006-02-23 Imclone Systems Incorporated Novel tetravalent bispecific antibody
CA2697922A1 (en) 2007-08-28 2009-03-12 Biogen Idec Ma Inc. Compositions that bind multiple epitopes of igf-1r
KR20250093620A (ko) * 2017-09-15 2025-06-24 암젠 인크 치료 단백질의 동결건조된 약학적 제형을 위한 방법
US20230348596A1 (en) * 2020-08-24 2023-11-02 Amgen Inc. Pharmaceutical formulation
AU2021338875A1 (en) * 2020-09-14 2023-02-23 Amgen Inc. Method of making lyophilized protein formulations

Also Published As

Publication number Publication date
KR20240016260A (ko) 2024-02-06
AU2022285665A9 (en) 2023-10-26
IL307677A (en) 2023-12-01
CL2023003443A1 (es) 2024-06-14
TW202313108A (zh) 2023-04-01
AU2022285665A1 (en) 2023-10-19
WO2022256359A1 (en) 2022-12-08
US20240368254A1 (en) 2024-11-07
CN117241787A (zh) 2023-12-15
EP4346778A1 (en) 2024-04-10
CA3217210A1 (en) 2022-12-08
JP2024521329A (ja) 2024-05-31
AR126044A1 (es) 2023-09-06
BR112023024757A2 (pt) 2024-02-15

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