RU2018121262A - Способ получения лиофилизированных пеллет, содержащих фактор viii - Google Patents
Способ получения лиофилизированных пеллет, содержащих фактор viii Download PDFInfo
- Publication number
- RU2018121262A RU2018121262A RU2018121262A RU2018121262A RU2018121262A RU 2018121262 A RU2018121262 A RU 2018121262A RU 2018121262 A RU2018121262 A RU 2018121262A RU 2018121262 A RU2018121262 A RU 2018121262A RU 2018121262 A RU2018121262 A RU 2018121262A
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- RU
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- Prior art keywords
- factor viii
- pellets
- solution
- lyophilized
- containing factor
- Prior art date
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B11/00—Machines or apparatus for drying solid materials or objects with movement which is non-progressive
- F26B11/02—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles
- F26B11/04—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles rotating about a horizontal or slightly-inclined axis
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B11/00—Machines or apparatus for drying solid materials or objects with movement which is non-progressive
- F26B11/02—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles
- F26B11/04—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles rotating about a horizontal or slightly-inclined axis
- F26B11/049—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles rotating about a horizontal or slightly-inclined axis with provisions for working under increased or reduced pressure, with or without heating
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B3/00—Drying solid materials or objects by processes involving the application of heat
- F26B3/02—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air
- F26B3/10—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour carrying the materials or objects to be dried with it
- F26B3/12—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour carrying the materials or objects to be dried with it in the form of a spray, i.e. sprayed or dispersed emulsions or suspensions
-
- 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
-
- 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
- F26B5/065—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 the product to be freeze-dried being sprayed, dispersed or pulverised
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Toxicology (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Microbiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Drying Of Solid Materials (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Claims (27)
1. Способ получения лиофилизированных пеллет, содержащих фактор VIII, причем способ включает стадии:
a) замораживания капель раствора, содержащего фактор VIII, с образованием пеллет;
b) лиофилизации пеллет;
отличающийся тем, что
на стадии а) капли образуются посредством образования капель раствора,
содержащего фактор VIII, в башне для охлаждения (100), которая имеет внутреннюю поверхность стенок с контролируемой температурой (110) и внутреннюю температуру ниже температуры замерзания раствора
и тем, что
на стадии b) пеллет лиофилизируют во вращающемся приемнике (210), который находится внутри вакуумной камеры (200).
2. Способ по п. 1, дополнительно включающий стадии с), d) и е) после стадии b):
c) хранения и гомогенизации лиофилизированных пеллет;
d) анализа лиофилизированных пеллет при их хранении и гомогенизации;
e) загрузки лиофилизированных пеллет в контейнеры.
3. Способ по п. 1, в котором на стадии а) капли получают посредством образования капель посредством пропускания раствора через сопла с характеристикой частоты.
4. Способ по п. 3, в котором частота колебаний составляет от ≥1000 Гц до ≤2000 Гц.
5. Способ по п. 1, в котором на стадии а) внутренняя поверхность (110) башни для охлаждения (100) имеет температуру ≤-120°С.
6. Способ по п. 1, в котором внутреннюю поверхность (110) башни для охлаждения (100) охлаждают посредством пропускания охлаждающего средства через одну или более труб (140), которые находятся в термическом контакте с внутренней поверхностью (110).
7. Способ по п. 2, в котором целевую дозу установлевуют для фактора VIII, причем анализ на стадии d) определяет активное содержание фактора VIII в лиофилизированных пеллет, и контейнеры загружают количеством лиофилизированных пеллет, которое обеспечивает дозу, которая равна целевой дозе или превышает целевую дозу на ≤25%.
8. Способ по п. 1, в котором пеллет, полученные на стадии а), имеют максимальное распределение частиц по размеру d50 от ≥200 мкм до ≤1500 мкм.
9. Способ по п. 1, в котором раствор, содержащий фактор VIII, на стадии а) имеет содержание растворенных твердых веществ от ≥8 мас. % до ≤12 мас. %.
10. Способ по любому из пп. 1-9, в котором раствор, содержащий фактор VIII, на стадии а) имеет следующий состав из расчета на 1 грамм раствора, причем остальным является вода для инъекции:
Фактор VIII от ≥99 ME до ≤101 ME
Сахароза от ≥68 мг до ≤72 мг
Гистидин от ≥2 мг до ≤4 мг
Глицин от ≥23 мг до ≤26 мг
NaCl от ≥1 мг до ≤3 мг
СаС12 от ≥0,2 мг до ≤0,4 мг
Полисорбат 80 от ≥0,07 мг до ≤0,1 мг.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15194340.4 | 2015-11-12 | ||
| EP15194340.4A EP3167877A1 (en) | 2015-11-12 | 2015-11-12 | Method for the production of freeze-dried pellets comprising factor viii |
| PCT/EP2016/076640 WO2017080915A1 (en) | 2015-11-12 | 2016-11-04 | Method for the production of freeze-dried pellets comprising factor viii |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2018121262A true RU2018121262A (ru) | 2019-12-13 |
| RU2018121262A3 RU2018121262A3 (ru) | 2020-03-06 |
| RU2735082C2 RU2735082C2 (ru) | 2020-10-28 |
Family
ID=54542063
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018121262A RU2735082C2 (ru) | 2015-11-12 | 2016-11-04 | Способ получения лиофилизированных пеллет, содержащих фактор viii |
Country Status (26)
| Country | Link |
|---|---|
| US (1) | US10407489B2 (ru) |
| EP (2) | EP3167877A1 (ru) |
| JP (1) | JP6869980B2 (ru) |
| KR (1) | KR20180068337A (ru) |
| CN (1) | CN108348471B (ru) |
| AU (1) | AU2016352568B2 (ru) |
| BR (1) | BR112018009620A8 (ru) |
| CA (1) | CA3004789A1 (ru) |
| CY (1) | CY1122680T1 (ru) |
| DK (1) | DK3373912T3 (ru) |
| ES (1) | ES2775698T3 (ru) |
| HK (1) | HK1252580A1 (ru) |
| HR (1) | HRP20200006T1 (ru) |
| IL (1) | IL259021B (ru) |
| LT (1) | LT3373912T (ru) |
| MX (1) | MX2018005855A (ru) |
| PE (1) | PE20181514A1 (ru) |
| PL (1) | PL3373912T3 (ru) |
| PT (1) | PT3373912T (ru) |
| RS (1) | RS59775B1 (ru) |
| RU (1) | RU2735082C2 (ru) |
| SA (1) | SA518391542B1 (ru) |
| SG (1) | SG11201803637PA (ru) |
| SI (1) | SI3373912T1 (ru) |
| WO (1) | WO2017080915A1 (ru) |
| ZA (1) | ZA201803869B (ru) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105674691B (zh) * | 2016-04-01 | 2017-11-21 | 苏州大学 | 用于收集喷雾冷冻冰球颗粒的双密封式设备及其收集方法 |
| KR102529391B1 (ko) | 2018-06-14 | 2023-05-04 | 현대자동차 주식회사 | 차량용 변속장치 |
| CN112543627A (zh) * | 2018-07-05 | 2021-03-23 | 拜耳公司 | 新型稳定的高浓度抗FXIa抗体制剂 |
| CN112432437A (zh) * | 2020-11-23 | 2021-03-02 | 苏州微克生活科技有限公司 | 一种应用于制备益生菌冻干粉的高速冻干系统 |
| JP7371208B2 (ja) | 2022-01-19 | 2023-10-30 | Ｋｍバイオロジクス株式会社 | ｖｏｎ Ｗｉｌｌｅｂｒａｎｄ因子含有製剤 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4757006A (en) | 1983-10-28 | 1988-07-12 | Genetics Institute, Inc. | Human factor VIII:C gene and recombinant methods for production |
| AU5772886A (en) | 1985-04-12 | 1986-11-05 | Genetics Institute Inc. | Novel procoagulant proteins |
| US5250421A (en) | 1986-01-03 | 1993-10-05 | Genetics Institute, Inc. | Method for producing factor VIII:C-type proteins |
| US5198349A (en) | 1986-01-03 | 1993-03-30 | Genetics Institute, Inc. | Method for producing factor VIII:C and analogs |
| JPH0387173A (ja) | 1987-09-10 | 1991-04-11 | Teijin Ltd | ヒト活性化天然型ファクター８ｃの製造方法及びそれに用いる形質転換体 |
| CA2124690C (en) | 1992-10-02 | 2007-09-11 | Thomas Osterberg | Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer |
| JP5149470B2 (ja) * | 1999-02-22 | 2013-02-20 | バクスター・インターナショナル・インコーポレイテッド | 新規のアルブミンを含有していない第ｖｉｉｉ因子処方物 |
| EP1794524B1 (en) * | 2004-07-23 | 2012-01-18 | Bayer Technology Services GmbH | Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals) |
| US8633152B2 (en) * | 2007-08-07 | 2014-01-21 | Nanomaterials Technology Pte Ltd | Process for making micro-sized protein particles |
| CA2742328C (en) | 2008-11-07 | 2019-02-26 | Baxter International Inc. | Factor viii formulations |
| US8407912B2 (en) * | 2010-09-16 | 2013-04-02 | Velico Medical, Inc. | Spray dried human plasma |
| EP2578975A1 (en) * | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Rotary drum freeze-dryer |
| EP2578974A1 (en) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Process line for the production of freeze-dried particles |
| EP2578976A1 (en) * | 2011-10-06 | 2013-04-10 | Sanofi Pasteur Sa | Rotary drum for use in a vacuum freeze-dryer |
| EP3082771B1 (en) * | 2013-12-19 | 2019-07-31 | Aerosol Therapeutics, LLC | Compositions and methods for atmospheric spray freeze drying |
| WO2015149143A2 (en) * | 2014-04-01 | 2015-10-08 | Advantech Bioscience Farmacêutica Ltda. | Stable factor viii formulations with low sugar-glycine |
-
2015
- 2015-11-12 EP EP15194340.4A patent/EP3167877A1/en not_active Withdrawn
-
2016
- 2016-11-04 MX MX2018005855A patent/MX2018005855A/es unknown
- 2016-11-04 EP EP16791576.8A patent/EP3373912B1/en active Active
- 2016-11-04 KR KR1020187016127A patent/KR20180068337A/ko active Search and Examination
- 2016-11-04 LT LTEP16791576.8T patent/LT3373912T/lt unknown
- 2016-11-04 US US15/775,730 patent/US10407489B2/en active Active
- 2016-11-04 CA CA3004789A patent/CA3004789A1/en active Pending
- 2016-11-04 PE PE2018000739A patent/PE20181514A1/es unknown
- 2016-11-04 BR BR112018009620A patent/BR112018009620A8/pt active Search and Examination
- 2016-11-04 AU AU2016352568A patent/AU2016352568B2/en not_active Ceased
- 2016-11-04 PT PT167915768T patent/PT3373912T/pt unknown
- 2016-11-04 PL PL16791576T patent/PL3373912T3/pl unknown
- 2016-11-04 ES ES16791576T patent/ES2775698T3/es active Active
- 2016-11-04 RU RU2018121262A patent/RU2735082C2/ru active
- 2016-11-04 WO PCT/EP2016/076640 patent/WO2017080915A1/en active Application Filing
- 2016-11-04 CN CN201680066105.4A patent/CN108348471B/zh not_active Expired - Fee Related
- 2016-11-04 SI SI201630596T patent/SI3373912T1/sl unknown
- 2016-11-04 RS RS20200035A patent/RS59775B1/sr unknown
- 2016-11-04 SG SG11201803637PA patent/SG11201803637PA/en unknown
- 2016-11-04 JP JP2018524244A patent/JP6869980B2/ja active Active
- 2016-11-04 DK DK16791576.8T patent/DK3373912T3/da active
-
2018
- 2018-04-29 IL IL259021A patent/IL259021B/en unknown
- 2018-05-09 SA SA518391542A patent/SA518391542B1/ar unknown
- 2018-06-11 ZA ZA2018/03869A patent/ZA201803869B/en unknown
- 2018-09-17 HK HK18111894.4A patent/HK1252580A1/zh unknown
-
2020
- 2020-01-03 HR HRP20200006TT patent/HRP20200006T1/hr unknown
- 2020-02-20 CY CY20201100158T patent/CY1122680T1/el unknown
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