MX2022009558A - Contenido de humedad residual objetivo para farmaco liofilizado. - Google Patents
Contenido de humedad residual objetivo para farmaco liofilizado.Info
- Publication number
- MX2022009558A MX2022009558A MX2022009558A MX2022009558A MX2022009558A MX 2022009558 A MX2022009558 A MX 2022009558A MX 2022009558 A MX2022009558 A MX 2022009558A MX 2022009558 A MX2022009558 A MX 2022009558A MX 2022009558 A MX2022009558 A MX 2022009558A
- Authority
- MX
- Mexico
- 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
Se proporcionan métodos de liofilización para preparar formulaciones de proteína para el almacenamiento a largo plazo a temperatura ambiente o para mejorar la estabilidad en el almacenamiento en refrigeración. Específicamente, la presente solicitud proporciona métodos de liofilización para obtener un porcentaje de humedad residual objetivo de un producto liofilizado, tal como 3-5% de humedad residual. El secado secundario de la liofilización puede realizarse bajo una tasa de desorción controlada a una temperatura similar a la temperatura de estante del secado primario. De manera alternativa, la liofilización puede realizarse sin una etapa de secado secundario distinguido.
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 |
---|---|
MX2022009558A true MX2022009558A (es) | 2022-09-09 |
Family
ID=74853726
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2022009558A MX2022009558A (es) | 2020-02-04 | 2021-02-04 | Contenido de humedad residual objetivo para farmaco liofilizado. |
Country Status (11)
Country | Link |
---|---|
US (3) | US11525629B2 (es) |
EP (1) | EP4100689A2 (es) |
JP (1) | JP2023514540A (es) |
KR (1) | KR20220129088A (es) |
CN (1) | CN115151772A (es) |
AU (1) | AU2021217370A1 (es) |
BR (1) | BR112022015272A2 (es) |
CA (1) | CA3168873A1 (es) |
IL (1) | IL295221A (es) |
MX (1) | MX2022009558A (es) |
WO (1) | WO2021158759A2 (es) |
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 |
BR112022015272A2 (pt) | 2022-09-20 |
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 |
JP2023514540A (ja) | 2023-04-06 |
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