JP2024521329A - 凍結乾燥タンパク質製剤を製造する迅速な方法 - Google Patents

凍結乾燥タンパク質製剤を製造する迅速な方法 Download PDF

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JP2024521329A
JP2024521329A JP2023573384A JP2023573384A JP2024521329A JP 2024521329 A JP2024521329 A JP 2024521329A JP 2023573384 A JP2023573384 A JP 2023573384A JP 2023573384 A JP2023573384 A JP 2023573384A JP 2024521329 A JP2024521329 A JP 2024521329A
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seq
mtorr
protein
formulation
hours
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Japanese (ja)
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JP2024521329A5 (cg-RX-API-DMAC10.html
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マコーミック，ジェフ
マコーリー，アーノルド
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アムジエン・インコーポレーテツド
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    • 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

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  • 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)
JP2023573384A 2021-06-01 2022-06-01 凍結乾燥タンパク質製剤を製造する迅速な方法 Pending JP2024521329A (ja)

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

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JP2024521329A true JP2024521329A (ja) 2024-05-31
JP2024521329A5 JP2024521329A5 (cg-RX-API-DMAC10.html) 2025-06-09

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JP2023573384A Pending JP2024521329A (ja) 2021-06-01 2022-06-01 凍結乾燥タンパク質製剤を製造する迅速な方法

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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)

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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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020534255A (ja) * 2017-09-15 2020-11-26 アムジエン・インコーポレーテツド 治療用タンパク質の凍結乾燥医薬配合物のためのプロセス

Family Cites Families (8)

* 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
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020534255A (ja) * 2017-09-15 2020-11-26 アムジエン・インコーポレーテツド 治療用タンパク質の凍結乾燥医薬配合物のためのプロセス

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, vol. 12, JPN6026028210, 7 October 2008 (2008-10-07), pages 543 - 553, ISSN: 0005903366 *

Also Published As

Publication number Publication date
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
BR112023024757A2 (pt) 2024-02-15
CA3217210A1 (en) 2022-12-08
IL307677A (en) 2023-12-01
MX2023014034A (es) 2023-12-15

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