BR112022015272A2 - Teor de umidade residual alvo para produto de fármaco liofilizado - Google Patents
Teor de umidade residual alvo para produto de fármaco liofilizadoInfo
- Publication number
- BR112022015272A2 BR112022015272A2 BR112022015272A BR112022015272A BR112022015272A2 BR 112022015272 A2 BR112022015272 A2 BR 112022015272A2 BR 112022015272 A BR112022015272 A BR 112022015272A BR 112022015272 A BR112022015272 A BR 112022015272A BR 112022015272 A2 BR112022015272 A2 BR 112022015272A2
- Authority
- BR
- Brazil
- Prior art keywords
- residual moisture
- lyophilization
- moisture content
- drug product
- lyophilized drug
- Prior art date
Links
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
-
- 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
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
- F26B25/22—Controlling the drying process in dependence on liquid content of solid materials or objects
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/044—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum for drying materials in a batch operation in an enclosure having a plurality of shelves which may be heated
Landscapes
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Epidemiology (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Drying Of Solid Materials (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
TEOR DE UMIDADE RESIDUAL ALVO PARA PRODUTO DE FÁRMACO LIOFILIZADO. A presente invenção refere-se a métodos de liofilização para preparar formulações de proteínas para armazenamento de longo prazo à temperatura ambiente ou estabilidade melhorada em armazenamento de refrigeração. Especificamente, o presente pedido fornece métodos de liofilização para obter uma porcentagem alvo de umidade residual de um produto liofilizado, tal como umidade residual de 3 a 5%. A secagem secundária da liofilização pode ser conduzida sob taxa controlada de dessorção sob uma temperatura que é semelhante à temperatura de prateleira da secagem primária. Alternativamente, a liofilização pode ser conduzida sem uma etapa de secagem secundária distinta.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062969961P | 2020-02-04 | 2020-02-04 | |
| PCT/US2021/016569 WO2021158759A2 (en) | 2020-02-04 | 2021-02-04 | Target residual moisture content for lyophilized drug product |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112022015272A2 true BR112022015272A2 (pt) | 2022-09-20 |
Family
ID=74853726
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112022015272A BR112022015272A2 (pt) | 2020-02-04 | 2021-02-04 | Teor de umidade residual alvo para produto de fármaco liofilizado |
Country Status (11)
| Country | Link |
|---|---|
| US (3) | US11525629B2 (pt) |
| EP (1) | EP4100689A2 (pt) |
| JP (1) | JP2023514540A (pt) |
| KR (1) | KR20220129088A (pt) |
| CN (1) | CN115151772A (pt) |
| AU (1) | AU2021217370A1 (pt) |
| BR (1) | BR112022015272A2 (pt) |
| CA (1) | CA3168873A1 (pt) |
| IL (1) | IL295221A (pt) |
| MX (1) | MX2022009558A (pt) |
| WO (1) | WO2021158759A2 (pt) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019192747A1 (de) * | 2018-04-05 | 2019-10-10 | Paechnatz Torsten | Gefriertrocknungsanlage und verfahren hierzu |
| CA3168873A1 (en) | 2020-02-04 | 2021-08-12 | Regeneron Pharmaceuticals, Inc. | Target residual moisture content for lyophilized drug product |
| CN114184005B (zh) * | 2021-11-11 | 2023-05-05 | 天津科技大学 | 可判断冻干过程一次与二次干燥临界点的干燥装置及方法 |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5336616A (en) | 1990-09-12 | 1994-08-09 | Lifecell Corporation | Method for processing and preserving collagen-based tissues for transplantation |
| US6284282B1 (en) * | 1998-04-29 | 2001-09-04 | Genentech, Inc. | Method of spray freeze drying proteins for pharmaceutical administration |
| US7572893B2 (en) * | 2004-08-17 | 2009-08-11 | Regeneron Pharmaceuticals, Inc. | IL-1 antagonist formulations |
| FR2881139A1 (fr) * | 2005-01-26 | 2006-07-28 | Agronomique Inst Nat Rech | Composition pour la lyophilisation de proteines |
| EP2377554A1 (en) * | 2005-07-22 | 2011-10-19 | Amgen, Inc | Concentrated protein lyophilates, methods and uses |
| EP1870649A1 (en) * | 2006-06-20 | 2007-12-26 | Octapharma AG | Lyophilisation targetting defined residual moisture by limited desorption energy levels |
| US8240065B2 (en) * | 2007-02-05 | 2012-08-14 | Praxair Technology, Inc. | Freeze-dryer and method of controlling the same |
| ES2968301T3 (es) * | 2008-08-05 | 2024-05-08 | Wyeth Llc | Liofilización por encima del colapso |
| CN101642565B (zh) * | 2008-08-07 | 2012-10-03 | 陕西北美基因股份有限公司 | 血红蛋白类氧载体冻干制剂的制备方法 |
| AR087305A1 (es) * | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| WO2013135826A1 (en) * | 2012-03-14 | 2013-09-19 | Project Pharmaceutics Gmbh | Improved lyophilization method |
| US20140259724A1 (en) | 2013-03-13 | 2014-09-18 | Hemcon Medical Technologies, Inc. | Low Aspect Ratio Staged Closure Devices, Systems, and Methods for Freeze-Drying, Storing, Reconstituting, and Administering Lyophilized Plasma |
| EP2916090A1 (en) | 2014-02-04 | 2015-09-09 | Project Pharmaceutics GmbH | Flowable lyophilisate |
| EP3123090A4 (en) * | 2014-03-24 | 2017-12-13 | Bioverativ Therapeutics Inc. | Lyophilized factor ix formulations |
| EP3769618A1 (en) * | 2014-06-09 | 2021-01-27 | Terumo BCT, Inc. | Lyophilization container |
| JP6768722B2 (ja) * | 2015-07-02 | 2020-10-14 | 大塚製薬株式会社 | 凍結乾燥医薬組成物 |
| US10113797B2 (en) * | 2016-09-09 | 2018-10-30 | Sp Industries, Inc. | Energy recovery in a freeze-drying system |
| EP3522867A1 (en) * | 2016-10-07 | 2019-08-14 | Regeneron Pharmaceuticals, Inc. | Room temperature stable lyophilized protein |
| CN110049778A (zh) * | 2016-12-22 | 2019-07-23 | 豪夫迈·罗氏有限公司 | 减少冻干多肽重构时间的方法和制剂 |
| CN106889058B (zh) * | 2017-02-20 | 2019-07-19 | 徐小杨 | 一种细胞冻干系统和方法 |
| SI3392584T1 (sl) * | 2017-04-21 | 2020-09-30 | Gea Lyophil Gmbh | Zamrzovalni sušilnik in postopek za induciranje nukleacije v proizvodih |
| CA3137246A1 (en) * | 2019-05-13 | 2020-11-19 | Bone Therapeutics Sa | Improved lyophilized formulations involving hyaluronic acid and plasmatic proteins, and uses thereof |
| US20220168353A1 (en) * | 2019-08-16 | 2022-06-02 | Cellphire Inc. | Freeze-dried platelet derivative compositions for treating antiplatelet induced coagulopathy |
| CA3168873A1 (en) * | 2020-02-04 | 2021-08-12 | Regeneron Pharmaceuticals, Inc. | Target residual moisture content for lyophilized drug product |
| KR20230035595A (ko) * | 2020-07-08 | 2023-03-14 | 리제너론 파아마슈티컬스, 인크. | 항-ctla-4 항체를 함유하는 안정화된 제형 |
-
2021
- 2021-02-04 CA CA3168873A patent/CA3168873A1/en active Pending
- 2021-02-04 EP EP21709529.8A patent/EP4100689A2/en active Pending
- 2021-02-04 IL IL295221A patent/IL295221A/en unknown
- 2021-02-04 AU AU2021217370A patent/AU2021217370A1/en active Pending
- 2021-02-04 US US17/167,527 patent/US11525629B2/en active Active
- 2021-02-04 WO PCT/US2021/016569 patent/WO2021158759A2/en unknown
- 2021-02-04 KR KR1020227030487A patent/KR20220129088A/ko unknown
- 2021-02-04 MX MX2022009558A patent/MX2022009558A/es unknown
- 2021-02-04 JP JP2022547191A patent/JP2023514540A/ja active Pending
- 2021-02-04 CN CN202180012726.5A patent/CN115151772A/zh active Pending
- 2021-02-04 BR BR112022015272A patent/BR112022015272A2/pt unknown
-
2022
- 2022-11-11 US US17/985,250 patent/US11713922B2/en active Active
-
2023
- 2023-06-09 US US18/208,018 patent/US20230358470A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US20230358470A1 (en) | 2023-11-09 |
| US20230077563A1 (en) | 2023-03-16 |
| US11525629B2 (en) | 2022-12-13 |
| WO2021158759A3 (en) | 2021-10-07 |
| EP4100689A2 (en) | 2022-12-14 |
| CN115151772A (zh) | 2022-10-04 |
| WO2021158759A2 (en) | 2021-08-12 |
| US11713922B2 (en) | 2023-08-01 |
| CA3168873A1 (en) | 2021-08-12 |
| KR20220129088A (ko) | 2022-09-22 |
| IL295221A (en) | 2022-10-01 |
| US20210239396A1 (en) | 2021-08-05 |
| AU2021217370A1 (en) | 2022-08-18 |
| MX2022009558A (es) | 2022-09-09 |
| JP2023514540A (ja) | 2023-04-06 |
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