JP7637618B2 - 高濃度タンパク質製剤 - Google Patents

高濃度タンパク質製剤 Download PDF

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Publication number
JP7637618B2
JP7637618B2 JP2021527899A JP2021527899A JP7637618B2 JP 7637618 B2 JP7637618 B2 JP 7637618B2 JP 2021527899 A JP2021527899 A JP 2021527899A JP 2021527899 A JP2021527899 A JP 2021527899A JP 7637618 B2 JP7637618 B2 JP 7637618B2
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Prior art keywords
protein
high concentration
formulation
less
protein formulation
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English (en)
Japanese (ja)
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JP2022532965A5 (https=
JP2022532965A (ja
Inventor
ハンター チェン、
エリカ シュレジンジャー、
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.)
Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/10—Dispersions; Emulsions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2021527899A 2018-11-21 2019-11-21 高濃度タンパク質製剤 Active JP7637618B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862770337P 2018-11-21 2018-11-21
US62/770,337 2018-11-21
PCT/US2019/062596 WO2020106948A1 (en) 2018-11-21 2019-11-21 High concentration protein formulation

Publications (3)

Publication Number Publication Date
JP2022532965A JP2022532965A (ja) 2022-07-21
JP2022532965A5 JP2022532965A5 (https=) 2022-11-28
JP7637618B2 true JP7637618B2 (ja) 2025-02-28

Family

ID=68916589

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2021527899A Active JP7637618B2 (ja) 2018-11-21 2019-11-21 高濃度タンパク質製剤

Country Status (14)

Country Link
US (2) US12036280B2 (https=)
EP (1) EP3883542A1 (https=)
JP (1) JP7637618B2 (https=)
KR (1) KR102944691B1 (https=)
CN (1) CN113164378A (https=)
AU (1) AU2019384160B2 (https=)
BR (1) BR112021009463A2 (https=)
CA (1) CA3118306A1 (https=)
EA (1) EA202191403A1 (https=)
IL (1) IL283229B2 (https=)
MX (1) MX2021005910A (https=)
SG (1) SG11202104166QA (https=)
WO (1) WO2020106948A1 (https=)
ZA (1) ZA202102816B (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
CA3231500A1 (en) * 2021-09-09 2023-03-16 Xeris Pharmaceuticals, Inc. Injectable high concentration pharmaceutical formulations and methods of manufacturing and use thereof
IL326704A (en) * 2023-08-24 2026-04-01 Rezolute Inc High-concentration anti-insulin receptor antibody formulations and their uses

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004515467A (ja) 2000-08-07 2004-05-27 ネクター セラピューティックス 吸入可能な、噴霧乾燥した、最少の凝集物を有する４−ヘリックスバンドルタンパク質粉末
JP2014510077A (ja) 2011-03-09 2014-04-24 ヤンセン バイオテツク，インコーポレーテツド 抗体の非水性高濃度減粘懸濁製剤
JP2015520164A (ja) 2012-05-18 2015-07-16 ジェネンテック， インコーポレイテッド 高濃度モノクローナル抗体製剤

Family Cites Families (12)

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Publication number Priority date Publication date Assignee Title
IT1142172B (it) * 1978-10-19 1986-10-08 Sandoz Ag Nuovo impiego in terapeutica della ciclosporina-a e della diidrociclosporina-c
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
US9072668B2 (en) * 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
CA2829629A1 (en) * 2011-03-10 2012-09-13 Board Of Regents, The University Of Texas System Protein nanoparticle dispersions
CN103356490A (zh) * 2012-03-29 2013-10-23 复旦大学 可直接固体化的交联食物蛋白稳定化纳米给药系统
UA117466C2 (uk) * 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
IL312865B2 (en) * 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
PL2942050T3 (pl) * 2014-05-06 2023-01-09 S.I.I.T. S.R.L.-Servizio Internazionale Imballaggi Termosaldanti Nadająca się do rozpylania olejowa kompozycja oparta na rozpuszczalnych w tłuszczach witaminach z grupy d oraz jej zastosowanie
WO2016109822A1 (en) * 2014-12-31 2016-07-07 Novelmed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies
EP3522918A1 (en) * 2016-10-06 2019-08-14 Amgen Inc. Reduced viscosity protein pharmaceutical formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004515467A (ja) 2000-08-07 2004-05-27 ネクター セラピューティックス 吸入可能な、噴霧乾燥した、最少の凝集物を有する４−ヘリックスバンドルタンパク質粉末
JP2014510077A (ja) 2011-03-09 2014-04-24 ヤンセン バイオテツク，インコーポレーテツド 抗体の非水性高濃度減粘懸濁製剤
JP2015520164A (ja) 2012-05-18 2015-07-16 ジェネンテック， インコーポレイテッド 高濃度モノクローナル抗体製剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
J. Pham. Sci.，2008年，vol.97, no.1，p.287-302

Also Published As

Publication number Publication date
EP3883542A1 (en) 2021-09-29
JP2022532965A (ja) 2022-07-21
IL283229A (en) 2021-07-29
AU2019384160A1 (en) 2021-05-27
EA202191403A1 (ru) 2021-08-09
US20200155678A1 (en) 2020-05-21
KR102944691B1 (ko) 2026-03-30
CN113164378A (zh) 2021-07-23
BR112021009463A2 (pt) 2021-08-10
MX2021005910A (es) 2021-08-16
CA3118306A1 (en) 2020-05-28
KR20210093976A (ko) 2021-07-28
IL283229B1 (en) 2025-04-01
ZA202102816B (en) 2024-08-28
IL283229B2 (en) 2025-08-01
US12036280B2 (en) 2024-07-16
SG11202104166QA (en) 2021-05-28
US20240316195A1 (en) 2024-09-26
WO2020106948A1 (en) 2020-05-28
AU2019384160B2 (en) 2025-01-16

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