CL2023000004A1 - Formulación en concentración alta de proteínas de unión a antígeno del factor xii - Google Patents
Formulación en concentración alta de proteínas de unión a antígeno del factor xiiInfo
- Publication number
- CL2023000004A1 CL2023000004A1 CL2023000004A CL2023000004A CL2023000004A1 CL 2023000004 A1 CL2023000004 A1 CL 2023000004A1 CL 2023000004 A CL2023000004 A CL 2023000004A CL 2023000004 A CL2023000004 A CL 2023000004A CL 2023000004 A1 CL2023000004 A1 CL 2023000004A1
- Authority
- CL
- Chile
- 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
- 239000004094 surface-active agent 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
- 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
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
Abstract
La presente solicitud está dirigida a una formulación líquida que comprende por lo menos 100 mg/ml de una proteína que comprende un dominio de unión de antígeno que se une a FXII (y/o su forma activada), un tampón orgánico, un surfactante 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. Las formulaciones ejemplares comprenden el anticuerpo del Factor XII específico 3F7, en formulación con un tampón histidina, un surfactante polisorbato 80 y los estabilizadores de aminoácidos arginina y prolina.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20184004 | 2020-07-03 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CL2023000004A1 true CL2023000004A1 (es) | 2023-08-25 |
Family
ID=71514949
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2023000004A CL2023000004A1 (es) | 2020-07-03 | 2023-01-03 | Formulación en concentración alta de proteínas de unión a antígeno del 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 |
|---|---|---|---|---|
| WO2022241148A1 (en) * | 2021-05-12 | 2022-11-17 | Anaptysbio, Inc. | Antibody composition |
| 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 |
|---|---|---|---|---|
| CA2841185C (en) * | 2011-07-22 | 2021-05-25 | Csl Behring Gmbh | Inhibitory anti -factor xii/xiia monoclonal antibodies and their uses |
| RU2014140137A (ru) * | 2012-03-08 | 2016-04-27 | Ф.Хоффманн-Ля Рош Аг | Лекарственный препарат антитела к бета-амилоиду |
| US8613919B1 (en) * | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| EA201890340A1 (ru) * | 2015-07-21 | 2018-09-28 | Дайэкс Корп. | Моноклональное антитело-ингибитор фактора xiia |
| CN109311986A (zh) * | 2016-03-25 | 2019-02-05 | 威特拉公司 | 登革热病毒抗体分子的制剂 |
| WO2017173494A1 (en) * | 2016-04-06 | 2017-10-12 | Csl Limited | Method of treating atherosclerosis |
| MX2019007564A (es) * | 2016-12-23 | 2019-09-06 | Serum Institute Of India Pvt Ltd | Metodos mejorados para estimular la productividad de anticuerpos en el cultivo de celulas de mamiferos y reducir la agregacion durante los procesos de formulacion corriente abajo y formulaciones de anticuerpos estables obtenidas a partir de los mismos. |
| US20220089776A1 (en) * | 2018-11-28 | 2022-03-24 | Oregon Health & Science University | Therapeutic factor xii antibody |
-
2021
- 2021-07-05 CA CA3183508A patent/CA3183508A1/en active Pending
- 2021-07-05 KR KR1020237003982A patent/KR20230035355A/ko unknown
- 2021-07-05 EP EP21834598.1A patent/EP4175669A1/en active Pending
- 2021-07-05 AU AU2021302684A patent/AU2021302684A1/en active Pending
- 2021-07-05 MX MX2022016365A patent/MX2022016365A/es unknown
- 2021-07-05 IL IL298989A patent/IL298989A/en unknown
- 2021-07-05 WO PCT/AU2021/050714 patent/WO2022000046A1/en active Application Filing
- 2021-07-05 CN CN202180053399.8A patent/CN116322764A/zh active Pending
- 2021-07-05 BR BR112022026482A patent/BR112022026482A2/pt unknown
- 2021-07-05 JP JP2022581380A patent/JP2023531315A/ja active Pending
-
2023
- 2023-01-03 CL CL2023000004A patent/CL2023000004A1/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA3183508A1 (en) | 2022-01-06 |
| AU2021302684A1 (en) | 2023-02-23 |
| BR112022026482A2 (pt) | 2023-01-31 |
| EP4175669A1 (en) | 2023-05-10 |
| IL298989A (en) | 2023-02-01 |
| JP2023531315A (ja) | 2023-07-21 |
| MX2022016365A (es) | 2023-01-30 |
| CN116322764A (zh) | 2023-06-23 |
| WO2022000046A1 (en) | 2022-01-06 |
| KR20230035355A (ko) | 2023-03-13 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CL2023000004A1 (es) | Formulación en concentración alta de proteínas de unión a antígeno del factor xii | |
| ES2569409T3 (es) | Composiciones de anticuerpo anti-CTLA-4 | |
| CY1126062T1 (el) | Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1 | |
| ES2548238T3 (es) | Formulaciones antagonistas de VEGF | |
| AR111773A1 (es) | Composición farmacéutica que comprende constructos de anticuerpos biespecíficos para almacenamiento y administración | |
| PE20060552A1 (es) | Composicion de anticuerpo her2 | |
| CO2019011021A2 (es) | Formulacion estable de anticuerpos | |
| CO5660273A2 (es) | Formulaciones de proteina y anticuerpo de alta concentracion | |
| AR079836A1 (es) | Formulaciones estabilizadas que contienen anticuerpos anti-receptor de interleuquina-6 (il-6r) | |
| ECSP19062769A (es) | Formulación de anticuerpo monoclonal anti-vrs | |
| PE20190469A1 (es) | Formulaciones, kits y metodos de anticuerpos inhibidores de masp-2 de baja viscosidad altamente concentrados | |
| CO6251275A2 (es) | Formulaciones de inmunoglobulina liofilizadas y metodos para su preparacion | |
| PE20200153A1 (es) | Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t | |
| PE20181889A1 (es) | Preparaciones que contienen anticuerpos | |
| ECSP088962A (es) | Nuevos herbicidas | |
| PE20091783A1 (es) | Anticuerpos anti-factor d humanizados | |
| AR093641A1 (es) | Eliminacion de celulas de cancer por celulas t citotoxicas circulantes especificas de virus utilizando proteinas multifuncion que comprenden cmh de clase i con diana en celulas de cancer | |
| EA200970880A1 (ru) | Стабильные композиции на основе антител | |
| BR112014023869A2 (pt) | proteínas nutritivas carregadas e métodos | |
| AR119080A1 (es) | Proteínas multiespecíficas | |
| PE20091713A1 (es) | Inhibicion del receptor para la proteina estimulante del macrofago (ron), composiciones y metodos | |
| BR112018003594A2 (pt) | cadeia pesada de imunoglobulina recombinante, anticorpos, método de produção de conjugado e conjugados | |
| BR112021013337A2 (pt) | Proteínas de ligação a patógenos | |
| AR100268A1 (es) | Formulación líquida que comprende compuesto neutralizante de gm-csf | |
| Cuello et al. | Oxidation of cardiac myofilament proteins: Priming for dysfunction? |