AR119293A1 - Composición y métodos para estabilizar formulaciones líquidas de proteínas - Google Patents

Composición y métodos para estabilizar formulaciones líquidas de proteínas

Info

Publication number
AR119293A1
AR119293A1 ARP200101823A ARP200101823A AR119293A1 AR 119293 A1 AR119293 A1 AR 119293A1 AR P200101823 A ARP200101823 A AR P200101823A AR P200101823 A ARP200101823 A AR P200101823A AR 119293 A1 AR119293 A1 AR 119293A1
Authority
AR
Argentina
Prior art keywords
antibody
liquid formulation
composition
methods
protein formulations
Prior art date
Application number
ARP200101823A
Other languages
English (en)
Inventor
Anthony Tomlinson
Isidro Angelo Eleazar Zarraga
Barthelemy Luc Demeule
Original Assignee
Genentech 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 Genentech Inc filed Critical Genentech Inc
Publication of AR119293A1 publication Critical patent/AR119293A1/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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

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

Abstract

Reivindicación 1: Una formulación líquida que comprende un polipéptido y un tensioactivo, en donde al menos aproximadamente 70% (% en peso) del tensioactivo son ésteres de ácidos grasos de polioxietileno (POE) de isosorbida. Reivindicación 8: La formulación líquida de la reivindicación 1, en donde el éster de ácidos grasos de POE de isosorbida es un compuesto de fórmula (1) en donde: a y b son independientemente números enteros de 2 a 28, siempre que la suma de a y de b sea un número entero de 5 - 30; R¹ y R² se seleccionan independientemente del grupo que consiste en hidrógeno y -C(O)R’’, en donde R’’ es un alquilo C₃₋₂₇ opcionalmente sustituido o un alquenilo C₃₋₂₇ opcionalmente sustituido; y R³ y R⁴ son independientemente hidrógeno. Reivindicación 25: La formulación líquida de cualquiera de las reivindicaciones 1 - 24, en donde el polipéptido es una proteína. Reivindicación 26: La formulación líquida de la reivindicación 25, en donde la proteína es un anticuerpo. Reivindicación 27: La formulación líquida de la reivindicación 26, en donde el anticuerpo se selecciona del grupo que consiste en un anticuerpo policlonal, un anticuerpo monoclonal, un anticuerpo humanizado, un anticuerpo humano, un anticuerpo quimérico y un fragmento de anticuerpo.
ARP200101823A 2019-06-28 2020-06-26 Composición y métodos para estabilizar formulaciones líquidas de proteínas AR119293A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201962868615P 2019-06-28 2019-06-28

Publications (1)

Publication Number Publication Date
AR119293A1 true AR119293A1 (es) 2021-12-09

Family

ID=71728902

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP200101823A AR119293A1 (es) 2019-06-28 2020-06-26 Composición y métodos para estabilizar formulaciones líquidas de proteínas

Country Status (13)

Country Link
US (2) US11865177B2 (es)
EP (1) EP3989937A1 (es)
JP (1) JP2022538293A (es)
KR (1) KR20220027940A (es)
CN (1) CN114040754A (es)
AR (1) AR119293A1 (es)
AU (1) AU2020304649A1 (es)
BR (1) BR112021026492A2 (es)
CA (1) CA3141050A1 (es)
IL (1) IL289219A (es)
MX (1) MX2021015694A (es)
TW (1) TW202114641A (es)
WO (1) WO2020264300A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021228917A1 (en) * 2020-05-15 2021-11-18 F. Hoffmann-La Roche Ag Prevention of visible particle formation in parenteral protein solutions

Family Cites Families (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4399216A (en) 1980-02-25 1983-08-16 The Trustees Of Columbia University Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5091178A (en) 1986-02-21 1992-02-25 Oncogen Tumor therapy with biologically active anti-tumor antibodies
US6548640B1 (en) 1986-03-27 2003-04-15 Btg International Limited Altered antibodies
US5567610A (en) 1986-09-04 1996-10-22 Bioinvent International Ab Method of producing human monoclonal antibodies and kit therefor
DE3889546T2 (de) 1987-12-21 1994-09-08 Univ Toledo Transformation von keimenden pflanzensamen mit hilfe von agrobacterium.
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5175384A (en) 1988-12-05 1992-12-29 Genpharm International Transgenic mice depleted in mature t-cells and methods for making transgenic mice
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5229275A (en) 1990-04-26 1993-07-20 Akzo N.V. In-vitro method for producing antigen-specific human monoclonal antibodies
US5633425A (en) 1990-08-29 1997-05-27 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
CA2089661C (en) 1990-08-29 2007-04-03 Nils Lonberg Transgenic non-human animals capable of producing heterologous antibodies
US5625126A (en) 1990-08-29 1997-04-29 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
US5545806A (en) 1990-08-29 1996-08-13 Genpharm International, Inc. Ransgenic non-human animals for producing heterologous antibodies
US5661016A (en) 1990-08-29 1997-08-26 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
US5571894A (en) 1991-02-05 1996-11-05 Ciba-Geigy Corporation Recombinant antibodies specific for a growth factor receptor
DE69233254T2 (de) 1991-06-14 2004-09-16 Genentech, Inc., South San Francisco Humanisierter Heregulin Antikörper
ES2136092T3 (es) 1991-09-23 1999-11-16 Medical Res Council Procedimientos para la produccion de anticuerpos humanizados.
US5587458A (en) 1991-10-07 1996-12-24 Aronex Pharmaceuticals, Inc. Anti-erbB-2 antibodies, combinations thereof, and therapeutic and diagnostic uses thereof
WO1993008829A1 (en) 1991-11-04 1993-05-13 The Regents Of The University Of California Compositions that mediate killing of hiv-infected cells
DE69333807T2 (de) 1992-02-06 2006-02-02 Chiron Corp., Emeryville Marker für krebs und biosynthetisches bindeprotein dafür
US5573905A (en) 1992-03-30 1996-11-12 The Scripps Research Institute Encoded combinatorial chemical libraries
CA2140280A1 (en) 1992-08-17 1994-03-03 Avi J. Ashkenazi Bispecific immunoadhesins
CA2207869A1 (en) 1994-12-02 1996-06-06 Chiron Corporation Method of promoting an immune response with a bispecific antibody
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
US5869046A (en) 1995-04-14 1999-02-09 Genentech, Inc. Altered polypeptides with increased half-life
US5837234A (en) 1995-06-07 1998-11-17 Cytotherapeutics, Inc. Bioartificial organ containing cells encapsulated in a permselective polyether suflfone membrane
DE19544393A1 (de) 1995-11-15 1997-05-22 Hoechst Schering Agrevo Gmbh Synergistische herbizide Mischungen
WO1999029888A1 (en) 1997-12-05 1999-06-17 The Scripps Research Institute Humanization of murine antibody
US20120294866A1 (en) 2010-01-19 2012-11-22 F. Hoffmann-La Roche Ag Pharmaceutical formulation for proteins
MX367748B (es) * 2012-12-21 2019-09-04 Glenmark Pharmaceuticals Sa Formulación de anticuerpo anti her2.
CA3007419A1 (en) * 2015-12-30 2017-07-06 Genentech, Inc. Formulations with reduced degradation of polysorbate
CN108421046A (zh) * 2018-04-16 2018-08-21 江苏保易制药有限公司 一种新型高纯度药用辅料聚山梨酯及其制备方法

Also Published As

Publication number Publication date
BR112021026492A2 (pt) 2022-02-08
TW202114641A (zh) 2021-04-16
KR20220027940A (ko) 2022-03-08
IL289219A (en) 2022-02-01
US11865177B2 (en) 2024-01-09
CN114040754A (zh) 2022-02-11
MX2021015694A (es) 2022-03-11
US20240123066A1 (en) 2024-04-18
AU2020304649A1 (en) 2022-01-06
JP2022538293A (ja) 2022-09-01
US20210015920A1 (en) 2021-01-21
CA3141050A1 (en) 2020-12-30
EP3989937A1 (en) 2022-05-04
WO2020264300A1 (en) 2020-12-30

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