PE20240650A1 - Formulaciones de anticuerpos - Google Patents
Formulaciones de anticuerposInfo
- Publication number
- PE20240650A1 PE20240650A1 PE2024000233A PE2024000233A PE20240650A1 PE 20240650 A1 PE20240650 A1 PE 20240650A1 PE 2024000233 A PE2024000233 A PE 2024000233A PE 2024000233 A PE2024000233 A PE 2024000233A PE 20240650 A1 PE20240650 A1 PE 20240650A1
- Authority
- PE
- Peru
- Prior art keywords
- seq
- liquid composition
- approximately
- antibody
- cdr2
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 6
- 108010047041 Complementarity Determining Regions Proteins 0.000 abstract 4
- 239000007788 liquid Substances 0.000 abstract 4
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 abstract 1
- 239000004475 Arginine Substances 0.000 abstract 1
- 208000015943 Coeliac disease Diseases 0.000 abstract 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 abstract 1
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 abstract 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 229930195712 glutamate Natural products 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000004094 surface-active agent Substances 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
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- 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
- A61K9/08—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
- A61K2039/545—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
- C07K2317/565—Complementarity determining region [CDR]
-
- 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)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
Referido a formulaciones de anticuerpos, como composicion liquida que comprende (a) un anticuerpo anti-IL-15 a una concentracion superior a aproximadamente 100 mg/ml, (b) de 70 mM a 210 mM aproximadamente de arginina base, (c) de 80 mM a 240 aproximadamente de glutamato, y (d) un tensioactivo, en donde el pH de la composicion liquida es de aproximadamente 4.5 a aproximadamente 5.5; como alternativa dicha composicion liquida comprende prolina y otro amortiguador. En donde el anticuerpo anti-IL-15, comprende una region determinante de complementariedad (CDR) 1 de cadena pesada (HC) de la SEQ ID NO: 1, una CDR2 de HC de la SEQ ID NO: 2, una CDR3 de HC de la SEQ ID NO: 3, una region determinante de complementariedad (CDR) 1 de cadena ligera (LC) de la SEQ ID NO: 4, una CDR2 de LC de la SEQ ID NO: 5, y una CDR3 de LC de la SEQ ID NO: 6. Tambien se refiere a metodos para preparar dicha composicion liquida, y su uso para tratar una enfermedad como la enfermedad celiaca.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163232299P | 2021-08-12 | 2021-08-12 | |
| US202263316604P | 2022-03-04 | 2022-03-04 | |
| PCT/US2022/040056 WO2023018870A1 (en) | 2021-08-12 | 2022-08-11 | Antibody formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20240650A1 true PE20240650A1 (es) | 2024-04-04 |
Family
ID=83151728
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2024000233A PE20240650A1 (es) | 2021-08-12 | 2022-08-11 | Formulaciones de anticuerpos |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US20240343795A1 (es) |
| EP (1) | EP4384217A1 (es) |
| JP (1) | JP2024532736A (es) |
| KR (1) | KR20240046881A (es) |
| AU (1) | AU2022325870A1 (es) |
| CA (1) | CA3228269A1 (es) |
| CL (1) | CL2024000401A1 (es) |
| CO (1) | CO2024001383A2 (es) |
| CR (1) | CR20240130A (es) |
| IL (1) | IL310275A (es) |
| MX (1) | MX2024001934A (es) |
| PE (1) | PE20240650A1 (es) |
| TW (1) | TW202319398A (es) |
| UY (1) | UY39896A (es) |
| WO (1) | WO2023018870A1 (es) |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW201605896A (zh) | 2013-08-30 | 2016-02-16 | 安美基股份有限公司 | Gitr抗原結合蛋白 |
| EP2963057A1 (en) | 2014-07-02 | 2016-01-06 | Calypso Biotech SA | Antibodies to IL-15 |
| MX2024001374A (es) | 2016-06-15 | 2024-02-27 | Amgen Inc | Anticuerpo anti-il-15 o fragmento de union a antigeno del mismo, para usarse en el tratamiento de la enfermedad celiaca, de la sensibilidad al gluten no celiaca y de la enfermedad celiaca refractaria. |
| EP3824906A1 (en) * | 2016-12-21 | 2021-05-26 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| JOP20190255A1 (ar) | 2017-04-28 | 2019-10-27 | Amgen Inc | صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها |
| AU2018258676B2 (en) * | 2017-04-28 | 2024-09-19 | Amgen Inc. | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
| UY38049A (es) | 2018-01-12 | 2019-07-31 | Amgen Inc | Anti-pd-1 anticuerpos y métodos de tratamiento |
| WO2021079337A1 (en) * | 2019-10-23 | 2021-04-29 | Cadila Healthcare Limited | Pharmaceutical formulation of anti-her2 antibody and preparation thereof |
-
2022
- 2022-08-11 EP EP22762210.7A patent/EP4384217A1/en active Pending
- 2022-08-11 AU AU2022325870A patent/AU2022325870A1/en active Pending
- 2022-08-11 WO PCT/US2022/040056 patent/WO2023018870A1/en not_active Ceased
- 2022-08-11 MX MX2024001934A patent/MX2024001934A/es unknown
- 2022-08-11 JP JP2024507886A patent/JP2024532736A/ja active Pending
- 2022-08-11 CR CR20240130A patent/CR20240130A/es unknown
- 2022-08-11 KR KR1020247007623A patent/KR20240046881A/ko active Pending
- 2022-08-11 UY UY0001039896A patent/UY39896A/es unknown
- 2022-08-11 TW TW111130262A patent/TW202319398A/zh unknown
- 2022-08-11 CA CA3228269A patent/CA3228269A1/en active Pending
- 2022-08-11 IL IL310275A patent/IL310275A/en unknown
- 2022-08-11 US US18/682,531 patent/US20240343795A1/en active Pending
- 2022-08-11 PE PE2024000233A patent/PE20240650A1/es unknown
-
2024
- 2024-02-08 CO CONC2024/0001383A patent/CO2024001383A2/es unknown
- 2024-02-09 CL CL2024000401A patent/CL2024000401A1/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA3228269A1 (en) | 2023-02-16 |
| KR20240046881A (ko) | 2024-04-11 |
| CL2024000401A1 (es) | 2024-06-21 |
| WO2023018870A1 (en) | 2023-02-16 |
| US20240343795A1 (en) | 2024-10-17 |
| MX2024001934A (es) | 2024-03-04 |
| TW202319398A (zh) | 2023-05-16 |
| CO2024001383A2 (es) | 2024-03-07 |
| UY39896A (es) | 2023-02-28 |
| AU2022325870A1 (en) | 2024-02-08 |
| EP4384217A1 (en) | 2024-06-19 |
| CR20240130A (es) | 2024-04-12 |
| JP2024532736A (ja) | 2024-09-10 |
| IL310275A (en) | 2024-03-01 |
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