BR112021009463A2 - formulação de proteína de alta concentração - Google Patents

formulação de proteína de alta concentração Download PDF

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Publication number
BR112021009463A2
BR112021009463A2 BR112021009463-6A BR112021009463A BR112021009463A2 BR 112021009463 A2 BR112021009463 A2 BR 112021009463A2 BR 112021009463 A BR112021009463 A BR 112021009463A BR 112021009463 A2 BR112021009463 A2 BR 112021009463A2
Authority
BR
Brazil
Prior art keywords
high concentration
protein
protein formulation
aqueous high
formulation
Prior art date
Application number
BR112021009463-6A
Other languages
English (en)
Portuguese (pt)
Inventor
Hunter Chen
Erica Schlesinger
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 BR112021009463A2 publication Critical patent/BR112021009463A2/pt

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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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; 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)
BR112021009463-6A 2018-11-21 2019-11-21 formulação de proteína de alta concentração BR112021009463A2 (pt)

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 (1)

Publication Number Publication Date
BR112021009463A2 true BR112021009463A2 (pt) 2021-08-10

Family

ID=68916589

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021009463-6A BR112021009463A2 (pt) 2018-11-21 2019-11-21 formulação de proteína de alta concentração

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

Family Cites Families (15)

* 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
US9072668B2 (en) * 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US20110223208A1 (en) 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
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
EP2849723B1 (en) * 2012-05-18 2018-05-02 Genentech, Inc. High-concentration monoclonal antibody formulations
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

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
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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Legal Events

Date Code Title Description
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]