CA3118306A1 - High concentration protein formulation - Google Patents
High concentration protein formulation Download PDFInfo
- Publication number
- CA3118306A1 CA3118306A1 CA3118306A CA3118306A CA3118306A1 CA 3118306 A1 CA3118306 A1 CA 3118306A1 CA 3118306 A CA3118306 A CA 3118306A CA 3118306 A CA3118306 A CA 3118306A CA 3118306 A1 CA3118306 A1 CA 3118306A1
- Authority
- CA
- Canada
- Prior art keywords
- high concentration
- protein
- protein formulation
- formulation
- aqueous high
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
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
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K9/10—Dispersions; Emulsions
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Dispersion Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862770337P | 2018-11-21 | 2018-11-21 | |
| US62/770,337 | 2018-11-21 | ||
| PCT/US2019/062596 WO2020106948A1 (en) | 2018-11-21 | 2019-11-21 | High concentration protein formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA3118306A1 true CA3118306A1 (en) | 2020-05-28 |
Family
ID=68916589
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3118306A Pending CA3118306A1 (en) | 2018-11-21 | 2019-11-21 | High concentration protein formulation |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US12036280B2 (https=) |
| EP (1) | EP3883542A1 (https=) |
| JP (1) | JP7637618B2 (https=) |
| KR (1) | KR102944691B1 (https=) |
| CN (1) | CN113164378A (https=) |
| AU (1) | AU2019384160B2 (https=) |
| BR (1) | BR112021009463A2 (https=) |
| CA (1) | CA3118306A1 (https=) |
| EA (1) | EA202191403A1 (https=) |
| IL (1) | IL283229B2 (https=) |
| MX (1) | MX2021005910A (https=) |
| SG (1) | SG11202104166QA (https=) |
| WO (1) | WO2020106948A1 (https=) |
| ZA (1) | ZA202102816B (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK4364724T3 (da) | 2018-05-10 | 2025-12-22 | Regeneron Pharma | Formuleringer med høj koncentration af VEGF-receptorfusionsprotein |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| CA3231500A1 (en) * | 2021-09-09 | 2023-03-16 | Xeris Pharmaceuticals, Inc. | Injectable high concentration pharmaceutical formulations and methods of manufacturing and use thereof |
| IL326704A (en) * | 2023-08-24 | 2026-04-01 | Rezolute Inc | High-concentration anti-insulin receptor antibody formulations and their uses |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1142172B (it) * | 1978-10-19 | 1986-10-08 | Sandoz Ag | Nuovo impiego in terapeutica della ciclosporina-a e della diidrociclosporina-c |
| US6629949B1 (en) | 2000-05-08 | 2003-10-07 | Sterling Medivations, Inc. | Micro infusion drug delivery device |
| US6659982B2 (en) | 2000-05-08 | 2003-12-09 | Sterling Medivations, Inc. | Micro infusion drug delivery device |
| CA2418960A1 (en) * | 2000-08-07 | 2002-02-14 | Inhale Therapeutic Systems, Inc. | Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| US9072668B2 (en) * | 2010-03-09 | 2015-07-07 | Janssen Biotech, Inc. | Non-aqueous high concentration reduced viscosity suspension formulations of antibodies |
| US20110223208A1 (en) | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
| CA2829629A1 (en) * | 2011-03-10 | 2012-09-13 | Board Of Regents, The University Of Texas System | Protein nanoparticle dispersions |
| CN103356490A (zh) * | 2012-03-29 | 2013-10-23 | 复旦大学 | 可直接固体化的交联食物蛋白稳定化纳米给药系统 |
| EP2849723B1 (en) * | 2012-05-18 | 2018-05-02 | Genentech, Inc. | High-concentration monoclonal antibody formulations |
| UA117466C2 (uk) * | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| IL312865B2 (en) * | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| PL2942050T3 (pl) * | 2014-05-06 | 2023-01-09 | S.I.I.T. S.R.L.-Servizio Internazionale Imballaggi Termosaldanti | Nadająca się do rozpylania olejowa kompozycja oparta na rozpuszczalnych w tłuszczach witaminach z grupy d oraz jej zastosowanie |
| WO2016109822A1 (en) * | 2014-12-31 | 2016-07-07 | Novelmed Therapeutics, Inc. | Formulation of aglycosylated therapeutic antibodies |
| EP3522918A1 (en) * | 2016-10-06 | 2019-08-14 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
-
2019
- 2019-11-21 IL IL283229A patent/IL283229B2/en unknown
- 2019-11-21 MX MX2021005910A patent/MX2021005910A/es unknown
- 2019-11-21 EP EP19821379.5A patent/EP3883542A1/en active Pending
- 2019-11-21 US US16/690,956 patent/US12036280B2/en active Active
- 2019-11-21 CN CN201980076726.4A patent/CN113164378A/zh active Pending
- 2019-11-21 SG SG11202104166QA patent/SG11202104166QA/en unknown
- 2019-11-21 WO PCT/US2019/062596 patent/WO2020106948A1/en not_active Ceased
- 2019-11-21 AU AU2019384160A patent/AU2019384160B2/en active Active
- 2019-11-21 BR BR112021009463-6A patent/BR112021009463A2/pt unknown
- 2019-11-21 EA EA202191403A patent/EA202191403A1/ru unknown
- 2019-11-21 KR KR1020217018710A patent/KR102944691B1/ko active Active
- 2019-11-21 CA CA3118306A patent/CA3118306A1/en active Pending
- 2019-11-21 JP JP2021527899A patent/JP7637618B2/ja active Active
-
2021
- 2021-04-28 ZA ZA2021/02816A patent/ZA202102816B/en unknown
-
2024
- 2024-06-05 US US18/734,030 patent/US20240316195A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| EP3883542A1 (en) | 2021-09-29 |
| JP7637618B2 (ja) | 2025-02-28 |
| JP2022532965A (ja) | 2022-07-21 |
| IL283229A (en) | 2021-07-29 |
| AU2019384160A1 (en) | 2021-05-27 |
| EA202191403A1 (ru) | 2021-08-09 |
| US20200155678A1 (en) | 2020-05-21 |
| KR102944691B1 (ko) | 2026-03-30 |
| CN113164378A (zh) | 2021-07-23 |
| BR112021009463A2 (pt) | 2021-08-10 |
| MX2021005910A (es) | 2021-08-16 |
| KR20210093976A (ko) | 2021-07-28 |
| IL283229B1 (en) | 2025-04-01 |
| ZA202102816B (en) | 2024-08-28 |
| IL283229B2 (en) | 2025-08-01 |
| US12036280B2 (en) | 2024-07-16 |
| SG11202104166QA (en) | 2021-05-28 |
| US20240316195A1 (en) | 2024-09-26 |
| WO2020106948A1 (en) | 2020-05-28 |
| AU2019384160B2 (en) | 2025-01-16 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20231120 |
|
| D00 | Search and/or examination requested or commenced |
Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D00-D120 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: VOLUNTARY SUBMISSION OF PRIOR ART RECEIVED Effective date: 20240703 |
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| MFA | Maintenance fee for application paid |
Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 5TH ANNIV.) - STANDARD Year of fee payment: 5 |
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| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20241025 |
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| D15 | Examination report completed |
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| P13 | Application amended |
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