AU2019384160B2 - High concentration protein formulation - Google Patents

High concentration protein formulation Download PDF

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Publication number
AU2019384160B2
AU2019384160B2 AU2019384160A AU2019384160A AU2019384160B2 AU 2019384160 B2 AU2019384160 B2 AU 2019384160B2 AU 2019384160 A AU2019384160 A AU 2019384160A AU 2019384160 A AU2019384160 A AU 2019384160A AU 2019384160 B2 AU2019384160 B2 AU 2019384160B2
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AU
Australia
Prior art keywords
protein
formulation
high concentration
protein formulation
less
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.)
Active
Application number
AU2019384160A
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English (en)
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AU2019384160A1 (en
Inventor
Hunter Chen
Erica SCHLESINGER
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
Original Assignee
Regeneron Pharmaceuticals 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 Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of AU2019384160A1 publication Critical patent/AU2019384160A1/en
Application granted granted Critical
Publication of AU2019384160B2 publication Critical patent/AU2019384160B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
AU2019384160A 2018-11-21 2019-11-21 High concentration protein formulation Active AU2019384160B2 (en)

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 (2)

Publication Number Publication Date
AU2019384160A1 AU2019384160A1 (en) 2021-05-27
AU2019384160B2 true AU2019384160B2 (en) 2025-01-16

Family

ID=68916589

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019384160A Active AU2019384160B2 (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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
US20120076800A1 (en) * 2010-03-09 2012-03-29 Weiguo Dai Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations of Antibodies
US20130309226A1 (en) * 2012-05-18 2013-11-21 Genentech, Inc. High-concentration monoclonal antibody formulations

Family Cites Families (12)

* 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
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
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
US20120076800A1 (en) * 2010-03-09 2012-03-29 Weiguo Dai Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations of Antibodies
US20130309226A1 (en) * 2012-05-18 2013-11-21 Genentech, Inc. High-concentration monoclonal antibody formulations

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
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

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