BR112018009620A8 - método para a produção de péletes secos por congelamento que compreendem fator viii - Google Patents
método para a produção de péletes secos por congelamento que compreendem fator viiiInfo
- Publication number
- BR112018009620A8 BR112018009620A8 BR112018009620A BR112018009620A BR112018009620A8 BR 112018009620 A8 BR112018009620 A8 BR 112018009620A8 BR 112018009620 A BR112018009620 A BR 112018009620A BR 112018009620 A BR112018009620 A BR 112018009620A BR 112018009620 A8 BR112018009620 A8 BR 112018009620A8
- Authority
- BR
- Brazil
- Prior art keywords
- factor viii
- freeze
- pellets
- production
- solution
- Prior art date
Links
Classifications
-
- 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
-
- 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)
-
- 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
Landscapes
- 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)
Abstract
trata-se de um método para a produção de péletes secos por congelamento que compreendem fator viii que compreende as etapas de: a) congelar gotículas de uma solução que compreende fator viii para formar péletes; b) secar por congelamento os péletes; em que, na etapa a), as gotículas são formadas por meio de formação de gotícula da solução que compreende fator viii em uma torre de resfriamento que tem uma superfície de parede interna de temperatura controlável e uma temperatura interior abaixo da temperatura de congelamento da solução e em que, na etapa b), os péletes são secos por congelamento em um receptáculo giratório que é alojado no interior de uma câmara de vácuo.
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 (2)
| Publication Number | Publication Date |
|---|---|
| BR112018009620A2 BR112018009620A2 (pt) | 2018-11-06 |
| BR112018009620A8 true BR112018009620A8 (pt) | 2019-02-26 |
Family
ID=54542063
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112018009620A BR112018009620A8 (pt) | 2015-11-12 | 2016-11-04 | método para a produção de péletes secos por congelamento que compreendem fator viii |
Country Status (26)
| Country | Link |
|---|---|
| US (1) | US10407489B2 (pt) |
| EP (2) | EP3167877A1 (pt) |
| JP (1) | JP6869980B2 (pt) |
| KR (1) | KR20180068337A (pt) |
| CN (1) | CN108348471B (pt) |
| AU (1) | AU2016352568B2 (pt) |
| BR (1) | BR112018009620A8 (pt) |
| CA (1) | CA3004789A1 (pt) |
| CY (1) | CY1122680T1 (pt) |
| DK (1) | DK3373912T3 (pt) |
| ES (1) | ES2775698T3 (pt) |
| HK (1) | HK1252580A1 (pt) |
| HR (1) | HRP20200006T1 (pt) |
| IL (1) | IL259021B (pt) |
| LT (1) | LT3373912T (pt) |
| MX (1) | MX2018005855A (pt) |
| PE (1) | PE20181514A1 (pt) |
| PL (1) | PL3373912T3 (pt) |
| PT (1) | PT3373912T (pt) |
| RS (1) | RS59775B1 (pt) |
| RU (1) | RU2735082C2 (pt) |
| SA (1) | SA518391542B1 (pt) |
| SG (1) | SG11201803637PA (pt) |
| SI (1) | SI3373912T1 (pt) |
| WO (1) | WO2017080915A1 (pt) |
| ZA (1) | ZA201803869B (pt) |
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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 7A ANUIDADE. |
|
| B11D | Dismissal acc. art. 38, par 2 of ipl - failure to pay fee after grant in time |