HRP20200006T1 - Postupak za proizvodnju zamrzavanjem osušenih peleta koji sadrže faktor viii - Google Patents

Postupak za proizvodnju zamrzavanjem osušenih peleta koji sadrže faktor viii Download PDF

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Publication number
HRP20200006T1
HRP20200006T1 HRP20200006TT HRP20200006T HRP20200006T1 HR P20200006 T1 HRP20200006 T1 HR P20200006T1 HR P20200006T T HRP20200006T T HR P20200006TT HR P20200006 T HRP20200006 T HR P20200006T HR P20200006 T1 HRP20200006 T1 HR P20200006T1
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HR
Croatia
Prior art keywords
freeze
factor viii
pellets
droplets
solution
Prior art date
Application number
HRP20200006TT
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English (en)
Inventor
Carsten Olbrich
Matthias Plitzko
Bernhard Luy
Stefan Christian SCHNEID
Original Assignee
Bayer Pharma Aktiengesellschaft
Priority date (The priority date 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 date listed.)
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Publication date
Application filed by Bayer Pharma Aktiengesellschaft filed Critical Bayer Pharma Aktiengesellschaft
Publication of HRP20200006T1 publication Critical patent/HRP20200006T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B11/00Machines or apparatus for drying solid materials or objects with movement which is non-progressive
    • F26B11/02Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles
    • F26B11/04Machines 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
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B11/00Machines or apparatus for drying solid materials or objects with movement which is non-progressive
    • F26B11/02Machines or apparatus for drying solid materials or objects with movement which is non-progressive in moving drums or other mainly-closed receptacles
    • F26B11/04Machines 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
    • F26B11/049Machines 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
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B3/00Drying solid materials or objects by processes involving the application of heat
    • F26B3/02Drying 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
    • F26B3/10Drying 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
    • F26B3/12Drying 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
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying 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
    • F26B5/06Drying 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
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying 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
    • F26B5/06Drying 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
    • F26B5/065Drying 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal 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)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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 (10)

1. Postupak za proizvodnju zamrzavanjem osušenih peleta koji sadrže faktor VIII, te postupak uključuje korake: a) zamrzavanje kapljica otopine koja sadrži faktor VIII da tvori pelete; b) sušenjem zamrzavanjem peleta; naznačen time što u koraku a) se kapljice oblikuju pomoću stvaranja kapljica otopine koja sadrži faktor VIII u rashladnom tornju (100) koji ima površinu unutarnje stjenke (110) kojoj se može kontrolirati temperatura i unutarnju temperaturu ispod temperature smrzavanja otopine i što se u koraku b) peleti suše zamrzavanjem u rotirajućem spremniku (210) koji je smješten unutar vakuumske komore (200).
2. Postupak prema patentnom zahtjevu 1, naznačen time što nadalje sadrži korake c), d) i e) nakon koraka b): c) skladištenje i homogeniziranje zamrzavanjem osušenih peleta d) ispitivanje zamrzavanjem osušenih peleta tijekom njihovog skladištenja i homogenizacije; e) punjenje zamrzavanjem osušenih peleta u spremnike.
3. Postupak prema patentnom zahtjevu 1 ili 2, naznačen time što se u koraku a) kapljice izrađuju pomoću nastajanja kapljica propuštanjem otopine kroz mlaznice sa oscilirajućom frekvencijom.
4. Postupak prema patentnom zahtjevu 3, naznačen time što je oscilirajuća frekvencija ≥ 1000 Hz do ≤ 2000 Hz.
5. Postupak prema jednom od patentnih zahtjeva 1 do 4, naznačen time što u koraku a) unutarnja površina (110) rashladnog tornja (100) ima temperaturu koja iznosi ≤ -120 °C.
6. Postupak prema jednom od patentnih zahtjeva 1 do 5, naznačen time što se unutarnja površina (110) rashladnog tornja (100) hladi propuštanjem rashladnog sredstva kroz jednu ili više cijevi (140) koje su u toplinskom kontaktu s unutarnjom površinom (110).
7. Postupak prema jednom od patentnih zahtjeva 2 do 6, naznačen time što tar se ciljna doza određuje za faktor VIII, ispitivanje u koraku d) određuje aktivni sadržaj faktora VIII u zamrzavanjem osušenim peletima i spremnici su napunjeni s količinom zamrzavanjem osušenih peleta koji osiguravaju dozu koja je jednaka ciljnoj dozi ili veća od ciljne doze za ≤ 25%.
8. Postupak prema jednom od patentnih zahtjeva 1 do 7, naznačen time što peleti dobiveni u koraku a) imaju maksimalnu raspodjelu veličine čestica d50 od ≥ 200 µm do ≤ 1500 µm.
9. Postupak prema jednom od patentnih zahtjeva 1 do 8, naznačen time što otopina koja sadrži faktor VIII u koraku a) ima sadržaj otopljenih krutih tvari od ≥ 8 masenih % do ≤ 12 masenih %.
10. Postupak prema jednom od patentnih zahtjeva 1 do 9, naznačen time što otopina koja sadrži faktor VIII u koraku a) ima sljedeći sastav u odnosu na 1 gram otopine, a ravnotežu čini voda za injekcije:
HRP20200006TT 2015-11-12 2020-01-03 Postupak za proizvodnju zamrzavanjem osušenih peleta koji sadrže faktor viii HRP20200006T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15194340.4A EP3167877A1 (en) 2015-11-12 2015-11-12 Method for the production of freeze-dried pellets comprising factor viii
EP16791576.8A EP3373912B1 (en) 2015-11-12 2016-11-04 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 (1)

Publication Number Publication Date
HRP20200006T1 true HRP20200006T1 (hr) 2020-03-20

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ID=54542063

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20200006TT HRP20200006T1 (hr) 2015-11-12 2020-01-03 Postupak za proizvodnju zamrzavanjem osušenih peleta koji sadrže faktor viii

Country Status (26)

Country Link
US (1) US10407489B2 (hr)
EP (2) EP3167877A1 (hr)
JP (1) JP6869980B2 (hr)
KR (1) KR20180068337A (hr)
CN (1) CN108348471B (hr)
AU (1) AU2016352568B2 (hr)
BR (1) BR112018009620A8 (hr)
CA (1) CA3004789A1 (hr)
CY (1) CY1122680T1 (hr)
DK (1) DK3373912T3 (hr)
ES (1) ES2775698T3 (hr)
HK (1) HK1252580A1 (hr)
HR (1) HRP20200006T1 (hr)
IL (1) IL259021B (hr)
LT (1) LT3373912T (hr)
MX (1) MX2018005855A (hr)
PE (1) PE20181514A1 (hr)
PL (1) PL3373912T3 (hr)
PT (1) PT3373912T (hr)
RS (1) RS59775B1 (hr)
RU (1) RU2735082C2 (hr)
SA (1) SA518391542B1 (hr)
SG (1) SG11201803637PA (hr)
SI (1) SI3373912T1 (hr)
WO (1) WO2017080915A1 (hr)
ZA (1) ZA201803869B (hr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
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
JP2021529800A (ja) * 2018-07-05 2021-11-04 バイエル アクチェンゲゼルシャフトBayer Aktiengesellschaft 抗FXIa抗体のための新規な安定した高濃度製剤
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

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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
NZ256921A (en) 1992-10-02 1996-05-28 Pharmacia Ab Formulations of coagulation factor viii and a non-ionic surfactant and their preparation
EP1820516B1 (en) * 1999-02-22 2013-07-24 University of Connecticut Novel albumin-free factor VIII formulations
WO2006008006A1 (en) 2004-07-23 2006-01-26 Bayer Technology Services Gmbh Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals)
WO2009020434A1 (en) * 2007-08-07 2009-02-12 Nanomaterials Technology Pte Ltd A 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
EP2578974A1 (en) 2011-10-05 2013-04-10 Sanofi Pasteur Sa Process line for the production of freeze-dried particles
EP2578975A1 (en) * 2011-10-05 2013-04-10 Sanofi Pasteur Sa Rotary drum freeze-dryer
EP2578976A1 (en) * 2011-10-06 2013-04-10 Sanofi Pasteur Sa Rotary drum for use in a vacuum freeze-dryer
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CA2944349A1 (en) * 2014-04-01 2015-10-08 Advantech Bioscience Farmaceutica Ltda. Stable factor viii formulations with low sugar-glycine

Also Published As

Publication number Publication date
KR20180068337A (ko) 2018-06-21
SG11201803637PA (en) 2018-05-30
US20180327478A1 (en) 2018-11-15
AU2016352568A1 (en) 2018-05-10
JP6869980B2 (ja) 2021-05-12
CY1122680T1 (el) 2021-03-12
EP3373912B1 (en) 2019-12-25
LT3373912T (lt) 2020-02-10
AU2016352568B2 (en) 2021-07-15
SI3373912T1 (sl) 2020-02-28
EP3373912A1 (en) 2018-09-19
CN108348471A (zh) 2018-07-31
RS59775B1 (sr) 2020-02-28
BR112018009620A8 (pt) 2019-02-26
HK1252580A1 (zh) 2019-05-31
DK3373912T3 (da) 2020-03-16
RU2018121262A3 (hr) 2020-03-06
PE20181514A1 (es) 2018-09-21
WO2017080915A1 (en) 2017-05-18
IL259021B (en) 2021-10-31
CN108348471B (zh) 2021-05-28
BR112018009620A2 (pt) 2018-11-06
IL259021A (en) 2018-06-28
SA518391542B1 (ar) 2022-01-10
ES2775698T3 (es) 2020-07-28
RU2735082C2 (ru) 2020-10-28
ZA201803869B (en) 2020-08-26
RU2018121262A (ru) 2019-12-13
PL3373912T3 (pl) 2020-06-29
PT3373912T (pt) 2020-03-05
MX2018005855A (es) 2018-11-09
EP3167877A1 (en) 2017-05-17
US10407489B2 (en) 2019-09-10
JP2018533597A (ja) 2018-11-15
CA3004789A1 (en) 2017-05-18

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