KR20240016260A - 동결건조 단백질 제형의 가속화된 제조 방법 - Google Patents

동결건조 단백질 제형의 가속화된 제조 방법 Download PDF

Info

Publication number
KR20240016260A
KR20240016260A KR1020237040273A KR20237040273A KR20240016260A KR 20240016260 A KR20240016260 A KR 20240016260A KR 1020237040273 A KR1020237040273 A KR 1020237040273A KR 20237040273 A KR20237040273 A KR 20237040273A KR 20240016260 A KR20240016260 A KR 20240016260A
Authority
KR
South Korea
Prior art keywords
gly
ser
thr
val
leu
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
KR1020237040273A
Other languages
English (en)
Korean (ko)
Inventor
제프 맥코믹
아놀드 맥컬리
Original Assignee
암젠 인크
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 암젠 인크 filed Critical 암젠 인크
Publication of KR20240016260A publication Critical patent/KR20240016260A/ko
Pending legal-status Critical Current

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
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • 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)
KR1020237040273A 2021-06-01 2022-06-01 동결건조 단백질 제형의 가속화된 제조 방법 Pending KR20240016260A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163195265P 2021-06-01 2021-06-01
US63/195,265 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
KR20240016260A true KR20240016260A (ko) 2024-02-06

Family

ID=82100125

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020237040273A Pending KR20240016260A (ko) 2021-06-01 2022-06-01 동결건조 단백질 제형의 가속화된 제조 방법

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
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
BR112023024757A2 (pt) 2024-02-15

Similar Documents

Publication Publication Date Title
US20240336685A1 (en) Methods for reducing aggregation of bispecific antibodies
KR20240016260A (ko) 동결건조 단백질 제형의 가속화된 제조 방법
JPWO2008029908A1 (ja) 抗体を含有する安定な凍結乾燥医薬製剤
KR20230058432A (ko) 약제학적 제형
JP2026047374A (ja) 医薬製剤
US20230310324A1 (en) Method of making lyophilized protein formulations
US20240316194A1 (en) Method of reconstituting lyophilized formulation
US20230167176A1 (en) Pharmaceutical formulation
EA051496B1 (ru) Ускоренный способ получения лиофилизированных белковых составов

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20231122

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20250530

Comment text: Request for Examination of Application