IL283229B2 - High concentration protein formulation - Google Patents

High concentration protein formulation

Info

Publication number
IL283229B2
IL283229B2 IL283229A IL28322921A IL283229B2 IL 283229 B2 IL283229 B2 IL 283229B2 IL 283229 A IL283229 A IL 283229A IL 28322921 A IL28322921 A IL 28322921A IL 283229 B2 IL283229 B2 IL 283229B2
Authority
IL
Israel
Prior art keywords
protein
high concentration
formulation
protein formulation
less
Prior art date
Application number
IL283229A
Other languages
English (en)
Hebrew (he)
Other versions
IL283229A (en
IL283229B1 (en
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of IL283229A publication Critical patent/IL283229A/en
Publication of IL283229B1 publication Critical patent/IL283229B1/en
Publication of IL283229B2 publication Critical patent/IL283229B2/en

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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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)
IL283229A 2018-11-21 2019-11-21 High concentration protein formulation IL283229B2 (en)

Applications Claiming Priority (2)

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

Publications (3)

Publication Number Publication Date
IL283229A IL283229A (en) 2021-07-29
IL283229B1 IL283229B1 (en) 2025-04-01
IL283229B2 true IL283229B2 (en) 2025-08-01

Family

ID=68916589

Family Applications (1)

Application Number Title Priority Date Filing Date
IL283229A IL283229B2 (en) 2018-11-21 2019-11-21 High concentration protein formulation

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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120076800A1 (en) * 2010-03-09 2012-03-29 Weiguo Dai Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations of Antibodies
US20120230913A1 (en) * 2011-03-10 2012-09-13 Board Of Regents, The University Of Texas System Protein nanoparticle dispersions
EP2683403A1 (en) * 2011-03-09 2014-01-15 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
EP2849723A1 (en) * 2012-05-18 2015-03-25 Genentech, Inc. High-concentration monoclonal antibody formulations
WO2016109822A1 (en) * 2014-12-31 2016-07-07 Novelmed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies

Family Cites Families (10)

* Cited by examiner, † Cited by third party
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
CA2418960A1 (en) * 2000-08-07 2002-02-14 Inhale Therapeutic Systems, Inc. Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
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
EP3522918A1 (en) * 2016-10-06 2019-08-14 Amgen Inc. Reduced viscosity protein pharmaceutical formulations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120076800A1 (en) * 2010-03-09 2012-03-29 Weiguo Dai Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations of Antibodies
EP2683403A1 (en) * 2011-03-09 2014-01-15 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US20120230913A1 (en) * 2011-03-10 2012-09-13 Board Of Regents, The University Of Texas System Protein nanoparticle dispersions
EP2849723A1 (en) * 2012-05-18 2015-03-25 Genentech, Inc. High-concentration monoclonal antibody formulations
WO2016109822A1 (en) * 2014-12-31 2016-07-07 Novelmed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies

Also Published As

Publication number Publication date
EP3883542A1 (en) 2021-09-29
JP7637618B2 (ja) 2025-02-28
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
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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