MX2022016365A - Formulacion de alta concentracion de proteinas de union a antigeno de factor xii. - Google Patents
Formulacion de alta concentracion de proteinas de union a antigeno de factor xii.Info
- Publication number
- MX2022016365A MX2022016365A MX2022016365A MX2022016365A MX2022016365A MX 2022016365 A MX2022016365 A MX 2022016365A MX 2022016365 A MX2022016365 A MX 2022016365A MX 2022016365 A MX2022016365 A MX 2022016365A MX 2022016365 A MX2022016365 A MX 2022016365A
- Authority
- MX
- Mexico
- Prior art keywords
- antigen binding
- factor xii
- formulation
- high concentration
- binding proteins
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 4
- 239000000203 mixture Substances 0.000 title abstract 4
- 102000025171 antigen binding proteins Human genes 0.000 title 1
- 108091000831 antigen binding proteins Proteins 0.000 title 1
- 150000001413 amino acids Chemical class 0.000 abstract 2
- 239000003381 stabilizer Substances 0.000 abstract 2
- 239000004475 Arginine Substances 0.000 abstract 1
- 102000000429 Factor XII Human genes 0.000 abstract 1
- 108010080865 Factor XII Proteins 0.000 abstract 1
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-Proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 abstract 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 abstract 1
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 abstract 1
- 239000000427 antigen Substances 0.000 abstract 1
- 102000036639 antigens Human genes 0.000 abstract 1
- 108091007433 antigens Proteins 0.000 abstract 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 1
- 239000012669 liquid formulation Substances 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 1
- 229920000053 polysorbate 80 Polymers 0.000 abstract 1
- 229940068968 polysorbate 80 Drugs 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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
- A61K9/08—Solutions
-
- 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
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- 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
-
- 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)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Peptides Or Proteins (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)
Abstract
La presente solicitud está dirigida a una formulación líquida que comprende al menos 100 mg/ml de una proteína que comprende un dominio de unión a antígeno que se une a FXII (y/o una forma activada del mismo), un regulador de pH orgánico, un agente tensoactivo no iónico y un estabilizador de aminoácidos, en donde el pH de la formulación es 5.0-6.5 y la viscosidad es inferior a 30 mPa*s a 20°C. Ejemplos de formulaciones comprenden el anticuerpo 3F7 específico del Factor XII, en una formulación con un regulador de pH de histidina, un agente tensoactivo de polisorbato 80 y los estabilizadores de aminoácidos arginina y prolina.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20184004 | 2020-07-03 | ||
| PCT/AU2021/050714 WO2022000046A1 (en) | 2020-07-03 | 2021-07-05 | High concentration formulation of factor xii antigen binding proteins |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2022016365A true MX2022016365A (es) | 2023-01-30 |
Family
ID=71514949
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2022016365A MX2022016365A (es) | 2020-07-03 | 2021-07-05 | Formulacion de alta concentracion de proteinas de union a antigeno de factor xii. |
Country Status (11)
| Country | Link |
|---|---|
| EP (1) | EP4175669A1 (es) |
| JP (1) | JP2023531315A (es) |
| KR (1) | KR20230035355A (es) |
| CN (1) | CN116322764A (es) |
| AU (1) | AU2021302684A1 (es) |
| BR (1) | BR112022026482A2 (es) |
| CA (1) | CA3183508A1 (es) |
| CL (1) | CL2023000004A1 (es) |
| IL (1) | IL298989A (es) |
| MX (1) | MX2022016365A (es) |
| WO (1) | WO2022000046A1 (es) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20240021800A (ko) * | 2021-05-12 | 2024-02-19 | 아납티스바이오, 아이엔씨. | 항체 조성물 |
| WO2023115112A1 (en) * | 2021-12-20 | 2023-06-29 | CSL Innovation Pty Ltd | Protein formulations and uses thereof |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9518127B2 (en) * | 2011-07-22 | 2016-12-13 | Csl Behring Gmbh | Inhibitory anti-factor XII/XIIA monoclonal antibodies and their uses |
| SG11201404481RA (en) * | 2012-03-08 | 2014-09-26 | Hoffmann La Roche | Abeta antibody formulation |
| US8613919B1 (en) * | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| MX2018000714A (es) * | 2015-07-21 | 2019-11-18 | Dyax Corp | Un inhibidor de anticuerpo monoclonal de factor xiia. |
| TWI763660B (zh) * | 2016-03-25 | 2022-05-11 | 美商威特拉公司 | 登革病毒的抗體分子之配方設計 |
| CN109071629A (zh) * | 2016-04-06 | 2018-12-21 | 杰特有限公司 | 治疗动脉粥样硬化的方法 |
| CR20190291A (es) * | 2016-12-23 | 2019-11-05 | Serum Institute Of India Pvt Ltd | Métodos mejorados para estimular la productividad de anticuerpos en el cultivo de células de mamiferos y reducir la agregación durante los procesos de formulación post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos |
| JP7478149B2 (ja) * | 2018-11-28 | 2024-05-02 | オレゴン ヘルス アンド サイエンス ユニバーシティー | 治療用第ｘｉｉ因子抗体 |
-
2021
- 2021-07-05 MX MX2022016365A patent/MX2022016365A/es unknown
- 2021-07-05 JP JP2022581380A patent/JP2023531315A/ja active Pending
- 2021-07-05 WO PCT/AU2021/050714 patent/WO2022000046A1/en active Application Filing
- 2021-07-05 EP EP21834598.1A patent/EP4175669A1/en active Pending
- 2021-07-05 CA CA3183508A patent/CA3183508A1/en active Pending
- 2021-07-05 CN CN202180053399.8A patent/CN116322764A/zh active Pending
- 2021-07-05 KR KR1020237003982A patent/KR20230035355A/ko unknown
- 2021-07-05 AU AU2021302684A patent/AU2021302684A1/en active Pending
- 2021-07-05 IL IL298989A patent/IL298989A/en unknown
- 2021-07-05 BR BR112022026482A patent/BR112022026482A2/pt unknown
-
2023
- 2023-01-03 CL CL2023000004A patent/CL2023000004A1/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JP2023531315A (ja) | 2023-07-21 |
| BR112022026482A2 (pt) | 2023-01-31 |
| CA3183508A1 (en) | 2022-01-06 |
| KR20230035355A (ko) | 2023-03-13 |
| EP4175669A1 (en) | 2023-05-10 |
| CN116322764A (zh) | 2023-06-23 |
| AU2021302684A1 (en) | 2023-02-23 |
| CL2023000004A1 (es) | 2023-08-25 |
| IL298989A (en) | 2023-02-01 |
| WO2022000046A1 (en) | 2022-01-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| MX2022016365A (es) | Formulacion de alta concentracion de proteinas de union a antigeno de factor xii. | |
| ES2569409T3 (es) | Composiciones de anticuerpo anti-CTLA-4 | |
| EA200870538A1 (ru) | Лиофилизированные композиции анти-egfr антител | |
| EA201992377A1 (ru) | Стабильная композиция антитела | |
| Arakawa et al. | Elution of antibodies from a Protein-A column by aqueous arginine solutions | |
| RU2013137740A (ru) | Жидкая композиция, содержащая антитело высокой концентрации | |
| EA201992613A1 (ru) | Фармацевтическая композиция, содержащая конструкции на основе биспецифического антитела, обеспечивающая улучшенное хранение и введение | |
| PE20191463A1 (es) | Anticuerpos biespecificos de union especifica pd1 y lag3 | |
| Huh et al. | The Identification of Free Cysteine Residues Within Antibodies a Potential Role for Free Cysteine Residues in Covalent Aggregation Because of Agitation Stress | |
| EA200970880A1 (ru) | Стабильные композиции на основе антител | |
| EA201790989A1 (ru) | Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации | |
| AU2012240050B2 (en) | Formulations with reduced viscosity | |
| EP4233892A3 (en) | Stable anti-ifnar1 formulation | |
| EA200700213A1 (ru) | Терапевтические композиции с нейротоксином ботулина | |
| Arakawa et al. | Protein aggregation under high concentration/density state during chromatographic and ultrafiltration processes | |
| RU2011142184A (ru) | Фармацевтический состав, содержащий молекулы антител с улучшенными свойствами | |
| BRPI0514340A (pt) | formulações de estabilização | |
| US20140044727A1 (en) | Formulations with reduced viscosity | |
| CO5660273A2 (es) | Formulaciones de proteina y anticuerpo de alta concentracion | |
| AR089787A1 (es) | Formulaciones estabilizadas que contienen anticuerpos anti-ang2 | |
| PE20200153A1 (es) | Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t | |
| EA201992570A1 (ru) | Составы на основе человеческих антител к rankl, а также способы их применения | |
| AU2019339740A8 (en) | CSF-1R antibody formulation | |
| EA202193240A1 (ru) | Стабилизированные составы, содержащие анти-angptl3 антитела | |
| ZA202207051B (en) | Programmed cell death receptor 1 antibody formulation and use thereof |