AR119293A1 - Composición y métodos para estabilizar formulaciones líquidas de proteínas - Google Patents
Composición y métodos para estabilizar formulaciones líquidas de proteínasInfo
- 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
Links
- 102000004169 proteins and genes Human genes 0.000 title abstract 3
- 108090000623 proteins and genes Proteins 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title 2
- 239000007788 liquid Substances 0.000 title 1
- 239000012669 liquid formulation Substances 0.000 abstract 5
- 229920003171 Poly (ethylene oxide) Polymers 0.000 abstract 3
- -1 polyoxyethylene Polymers 0.000 abstract 3
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 abstract 2
- KLDXJTOLSGUMSJ-JGWLITMVSA-N Isosorbide Chemical compound O[C@@H]1CO[C@@H]2[C@@H](O)CO[C@@H]21 KLDXJTOLSGUMSJ-JGWLITMVSA-N 0.000 abstract 2
- 235000014113 dietary fatty acids Nutrition 0.000 abstract 2
- 229930195729 fatty acid Natural products 0.000 abstract 2
- 239000000194 fatty acid Substances 0.000 abstract 2
- 229910052739 hydrogen Inorganic materials 0.000 abstract 2
- 239000001257 hydrogen Substances 0.000 abstract 2
- 229960002479 isosorbide Drugs 0.000 abstract 2
- 229920001184 polypeptide Polymers 0.000 abstract 2
- 102000004196 processed proteins & peptides Human genes 0.000 abstract 2
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 2
- 239000004094 surface-active agent Substances 0.000 abstract 2
- 102000008394 Immunoglobulin Fragments Human genes 0.000 abstract 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 abstract 1
- 125000003342 alkenyl group Chemical group 0.000 abstract 1
- 125000000217 alkyl group Chemical group 0.000 abstract 1
- 150000001875 compounds Chemical class 0.000 abstract 1
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
-
- 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)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Dispersion Chemistry (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.
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 (2) | 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) | IL289219B1 (es) |
| MX (1) | MX2021015694A (es) |
| TW (1) | TWI844697B (es) |
| WO (1) | WO2020264300A1 (es) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115605184A (zh) * | 2020-05-15 | 2023-01-13 | 豪夫迈·罗氏有限公司（Ch） | 防止胃肠外蛋白质溶液中的可见颗粒形成 |
Family Cites Families (35)
| 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 |
| WO1989005859A1 (en) | 1987-12-21 | 1989-06-29 | The Upjohn Company | Agrobacterium mediated transformation of germinating plant seeds |
| 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 |
| US6150584A (en) | 1990-01-12 | 2000-11-21 | Abgenix, Inc. | Human antibodies derived from immunized xenomice |
| US6075181A (en) | 1990-01-12 | 2000-06-13 | 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 |
| US5661016A (en) | 1990-08-29 | 1997-08-26 | Genpharm International Inc. | Transgenic non-human animals capable of producing heterologous antibodies of various isotypes |
| US5633425A (en) | 1990-08-29 | 1997-05-27 | Genpharm International, Inc. | 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 |
| DK0814159T3 (da) | 1990-08-29 | 2005-10-24 | Genpharm Int | Transgene, ikke-humane dyr, der er i stand til at danne heterologe antistoffer |
| US5571894A (en) | 1991-02-05 | 1996-11-05 | Ciba-Geigy Corporation | Recombinant antibodies specific for a growth factor receptor |
| US6407213B1 (en) | 1991-06-14 | 2002-06-18 | Genentech, Inc. | Method for making humanized antibodies |
| US5565332A (en) | 1991-09-23 | 1996-10-15 | Medical Research Council | Production of chimeric antibodies - a combinatorial approach |
| 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 |
| WO1993016185A2 (en) | 1992-02-06 | 1993-08-19 | Creative Biomolecules, Inc. | Biosynthetic binding protein for cancer marker |
| US5573905A (en) | 1992-03-30 | 1996-11-12 | The Scripps Research Institute | Encoded combinatorial chemical libraries |
| WO1994004690A1 (en) | 1992-08-17 | 1994-03-03 | Genentech, Inc. | Bispecific immunoadhesins |
| AU4289496A (en) | 1994-12-02 | 1996-06-19 | 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 |
| ES2375931T3 (es) | 1997-12-05 | 2012-03-07 | The Scripps Research Institute | Humanización de anticuerpo murino. |
| US20120294866A1 (en) | 2010-01-19 | 2012-11-22 | F. Hoffmann-La Roche Ag | Pharmaceutical formulation for proteins |
| SG11201504897YA (en) | 2012-12-21 | 2015-07-30 | Glenmark Pharmaceuticals Sa | Anti her2 antibody formulation |
| EP3397287A1 (en) | 2015-12-30 | 2018-11-07 | 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 |
-
2020
- 2020-06-26 WO PCT/US2020/039827 patent/WO2020264300A1/en active Application Filing
- 2020-06-26 US US16/914,100 patent/US11865177B2/en active Active
- 2020-06-26 AR ARP200101823A patent/AR119293A1/es unknown
- 2020-06-26 JP JP2021577359A patent/JP2022538293A/ja active Pending
- 2020-06-26 AU AU2020304649A patent/AU2020304649A1/en active Pending
- 2020-06-26 EP EP20743431.7A patent/EP3989937A1/en active Pending
- 2020-06-26 BR BR112021026492A patent/BR112021026492A2/pt unknown
- 2020-06-26 MX MX2021015694A patent/MX2021015694A/es unknown
- 2020-06-26 CA CA3141050A patent/CA3141050A1/en active Pending
- 2020-06-26 IL IL289219A patent/IL289219B1/en unknown
- 2020-06-26 KR KR1020227000481A patent/KR20220027940A/ko unknown
- 2020-06-26 CN CN202080047738.7A patent/CN114040754A/zh active Pending
- 2020-06-29 TW TW109121897A patent/TWI844697B/zh active
-
2023
- 2023-12-06 US US18/531,442 patent/US20240123066A1/en active Pending
-
2024
- 2024-10-24 JP JP2024187611A patent/JP2025023952A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CA3141050A1 (en) | 2020-12-30 |
| IL289219B1 (en) | 2025-02-01 |
| TWI844697B (zh) | 2024-06-11 |
| US11865177B2 (en) | 2024-01-09 |
| JP2025023952A (ja) | 2025-02-19 |
| US20240123066A1 (en) | 2024-04-18 |
| AU2020304649A1 (en) | 2022-01-06 |
| IL289219A (en) | 2022-02-01 |
| TW202114641A (zh) | 2021-04-16 |
| US20210015920A1 (en) | 2021-01-21 |
| WO2020264300A1 (en) | 2020-12-30 |
| CN114040754A (zh) | 2022-02-11 |
| EP3989937A1 (en) | 2022-05-04 |
| BR112021026492A2 (pt) | 2022-02-08 |
| KR20220027940A (ko) | 2022-03-08 |
| MX2021015694A (es) | 2022-03-11 |
| JP2022538293A (ja) | 2022-09-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |