CN117241787A - 制备冻干蛋白配制品的加速方法 - Google Patents

制备冻干蛋白配制品的加速方法 Download PDF

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Publication number
CN117241787A
CN117241787A CN202280030941.2A CN202280030941A CN117241787A CN 117241787 A CN117241787 A CN 117241787A CN 202280030941 A CN202280030941 A CN 202280030941A CN 117241787 A CN117241787 A CN 117241787A
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CN
China
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
CN202280030941.2A
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English (en)
Chinese (zh)
Inventor
J·麦考密克
A·麦考利
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amgen Inc
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 CN117241787A publication Critical patent/CN117241787A/zh
Pending legal-status Critical Current

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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)
CN202280030941.2A 2021-06-01 2022-06-01 制备冻干蛋白配制品的加速方法 Pending CN117241787A (zh)

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
CN117241787A true CN117241787A (zh) 2023-12-15

Family

ID=82100125

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202280030941.2A Pending CN117241787A (zh) 2021-06-01 2022-06-01 制备冻干蛋白配制品的加速方法

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
CA2409991A1 (en) 2000-05-24 2001-11-29 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
KR20100052545A (ko) 2007-08-28 2010-05-19 바이오겐 아이덱 엠에이 인코포레이티드 Igf―1r의 다중 에피토프에 결합하는 조성물
EA202090731A1 (ru) * 2017-09-15 2020-06-11 Эмджен Инк. Способ получения лиофилизированного фармацевтического состава на основе терапевтического белка
EP4200333A1 (en) * 2020-08-24 2023-06-28 Amgen Inc. Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine
JP2023541133A (ja) * 2020-09-14 2023-09-28 アムジエン・インコーポレーテツド 凍結乾燥タンパク質製剤を作製する方法

Also Published As

Publication number Publication date
AR126044A1 (es) 2023-09-06
IL307677A (en) 2023-12-01
BR112023024757A2 (pt) 2024-02-15
AU2022285665A1 (en) 2023-10-19
KR20240016260A (ko) 2024-02-06
CA3217210A1 (en) 2022-12-08
US20240368254A1 (en) 2024-11-07
MX2023014034A (es) 2023-12-15
WO2022256359A1 (en) 2022-12-08
AU2022285665A9 (en) 2023-10-26
TW202313108A (zh) 2023-04-01
EP4346778A1 (en) 2024-04-10
JP2024521329A (ja) 2024-05-31
CL2023003443A1 (es) 2024-06-14

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