MX2023010365A - Proteina liofilizada estable a temperatura ambiente. - Google Patents

Proteina liofilizada estable a temperatura ambiente.

Info

Publication number
MX2023010365A
MX2023010365A MX2023010365A MX2023010365A MX2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A
Authority
MX
Mexico
Prior art keywords
room temperature
stable lyophilized
temperature stable
protein
lyophilized protein
Prior art date
Application number
MX2023010365A
Other languages
English (en)
Inventor
David Brett Ludwig
Xiaolin Tang
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 MX2023010365A publication Critical patent/MX2023010365A/es

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
    • 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
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—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
    • 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
    • A61K9/0012—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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Se proporcionan composiciones de proteínas terapéuticas liofilizadas estables y sus métodos de fabricación. Específicamente, se describe el uso de agua como plastificante de torta sólido y estabilizante de proteínas. Además, se describe la inclusión de un estabilizante multicomponente que comprende una entidad molecular más grande y una entidad molecular más pequeña. Además, la inclusión del recocido posterior al secado en ciertas condiciones mejora la estabilidad de la proteína. Se predice que las proteínas permanecerán estables durante 24 meses a 25°C.
MX2023010365A 2016-10-07 2019-04-02 Proteina liofilizada estable a temperatura ambiente. MX2023010365A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201662405610P 2016-10-07 2016-10-07

Publications (1)

Publication Number Publication Date
MX2023010365A true MX2023010365A (es) 2023-09-12

Family

ID=60302444

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2019003800A MX2019003800A (es) 2016-10-07 2017-10-06 Proteina liofilizada estable a temperatura ambiente.
MX2023010365A MX2023010365A (es) 2016-10-07 2019-04-02 Proteina liofilizada estable a temperatura ambiente.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2019003800A MX2019003800A (es) 2016-10-07 2017-10-06 Proteina liofilizada estable a temperatura ambiente.

Country Status (14)

Country Link
US (3) US11351256B2 (es)
EP (1) EP3522867A1 (es)
JP (1) JP2019534263A (es)
KR (2) KR20230164205A (es)
CN (1) CN110022855B (es)
AU (2) AU2017341067B2 (es)
BR (1) BR112019006907A2 (es)
CA (1) CA3039655A1 (es)
EA (1) EA201990900A1 (es)
IL (2) IL265665B2 (es)
MX (2) MX2019003800A (es)
MY (1) MY197672A (es)
TW (2) TW202237071A (es)
WO (1) WO2018068012A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11202010684YA (en) * 2018-05-10 2020-11-27 Regeneron Pharma High concentration vegf receptor fusion protein containing formulations
WO2020021330A2 (en) * 2018-07-12 2020-01-30 Endo Global Aesthetics Limited Injection techniques for the treatment of cellulite
WO2020142701A1 (en) * 2019-01-06 2020-07-09 Endo Global Aesthetics Limited Collagenase formulations and methods of producing the same
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.
DK3744319T3 (da) * 2019-05-28 2023-01-16 Ilkogen Ilac Sanayi Ve Ticaret A S Stabil lyofiliseret formulering til hybrid fc-fusioneret g-csf
CN113116831A (zh) * 2019-12-26 2021-07-16 天士力生物医药股份有限公司 一种注射用重组人尿激酶原的冻干方法
MX2022009558A (es) * 2020-02-04 2022-09-09 Regeneron Pharma Contenido de humedad residual objetivo para farmaco liofilizado.
EP4210679A1 (en) * 2020-09-14 2023-07-19 Amgen Inc. Method of making lyophilized protein formulations
TW202417038A (zh) 2022-06-15 2024-05-01 法商賽諾菲公司 高度濃縮的抗體組成物

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US5798032A (en) * 1994-06-02 1998-08-25 The Perkin-Elmer Corporation Method and apparatus for automated carbohydrate mapping and sequencing
CN102416176A (zh) * 1995-07-27 2012-04-18 基因技术股份有限公司 稳定等渗的冻干蛋白质制剂
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
US6149626A (en) 1997-10-03 2000-11-21 Bachynsky; Nicholas Automatic injecting syringe apparatus
US6436897B2 (en) 1998-06-01 2002-08-20 Celtrix Pharmaceuticals, Inc. Pharmaceutical formulations for IGF/IGFBP
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JP3727317B2 (ja) 2002-03-08 2005-12-14 エイエスエムエル ネザランドズ ベスローテン フエンノートシャップ リソグラフィに使用するためのマスク、マスクを作成する方法、リソグラフィ装置、およびデバイス製造方法
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Also Published As

Publication number Publication date
US20180099049A1 (en) 2018-04-12
AU2024200482A1 (en) 2024-02-15
IL265665B1 (en) 2024-03-01
TW202237071A (zh) 2022-10-01
KR20230164205A (ko) 2023-12-01
BR112019006907A2 (pt) 2019-07-02
IL265665B2 (en) 2024-07-01
TW201818924A (zh) 2018-06-01
US20200046834A1 (en) 2020-02-13
MX2019003800A (es) 2019-08-12
WO2018068012A1 (en) 2018-04-12
TWI766890B (zh) 2022-06-11
CN110022855A (zh) 2019-07-16
US11351256B2 (en) 2022-06-07
EP3522867A1 (en) 2019-08-14
EA201990900A1 (ru) 2019-07-31
MY197672A (en) 2023-07-03
JP2019534263A (ja) 2019-11-28
US20220257763A1 (en) 2022-08-18
IL265665A (en) 2019-05-30
AU2017341067B2 (en) 2023-10-26
AU2017341067A1 (en) 2019-04-11
CA3039655A1 (en) 2018-04-12
IL310367A (en) 2024-03-01
US11241498B2 (en) 2022-02-08
KR102605317B1 (ko) 2023-11-24
KR20190066014A (ko) 2019-06-12
CN110022855B (zh) 2024-07-16

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