PE20181514A1 - Metodo para la produccion de pelletss liofilizados que comprenden el factor viii - Google Patents

Metodo para la produccion de pelletss liofilizados que comprenden el factor viii

Info

Publication number
PE20181514A1
PE20181514A1 PE2018000739A PE2018000739A PE20181514A1 PE 20181514 A1 PE20181514 A1 PE 20181514A1 PE 2018000739 A PE2018000739 A PE 2018000739A PE 2018000739 A PE2018000739 A PE 2018000739A PE 20181514 A1 PE20181514 A1 PE 20181514A1
Authority
PE
Peru
Prior art keywords
factor viii
pellets
production
lyophilized
solution
Prior art date
Application number
PE2018000739A
Other languages
English (en)
Inventor
Carsten Olbrich
Matthias Plitzko
Bernhard Luy
Stefan Christian Schneid
Original Assignee
Bayer Pharma AG
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.)
Filing date
Publication date
Application filed by Bayer Pharma AG filed Critical Bayer Pharma AG
Publication of PE20181514A1 publication Critical patent/PE20181514A1/es

Links

Classifications

    • 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
    • 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
    • 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)
  • 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)

Abstract

Un metodo para la produccion de pellets liofilizados que comprenden el Factor VIII. Un metodo para la produccion de pellets liofilizados que comprenden el Factor VIII, el cual comprende los pasos de: a) Congelar gotas de una solucion que comprende el Factor VIII para formar pellets. b) Liofilizacion de los pellets. Donde en el paso a) las gotas se forman mediante la solucion que comprende el Factor VIII en una torre de enfriamiento, la cual tiene una superficie de pared interna controlable por temperatura y una temperatura interior por debajo de la temperatura de congelacion de la solucion y en el paso b) los pellets se liofilizan en un tambor giratorio que se encuentra alojado dentro de una camara de vacio.
PE2018000739A 2015-11-12 2016-11-04 Metodo para la produccion de pelletss liofilizados que comprenden el factor viii PE20181514A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
PE20181514A1 true PE20181514A1 (es) 2018-09-21

Family

ID=54542063

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2018000739A PE20181514A1 (es) 2015-11-12 2016-11-04 Metodo para la produccion de pelletss liofilizados que comprenden el factor viii

Country Status (26)

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

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

Family Cites Families (16)

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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
DK3082771T3 (da) * 2013-12-19 2019-09-02 Aerosol Therapeutics Llc Sammensætninger og fremgangsmåder til atmosfærisk sprøjtefrysetørring
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 (es) 2020-03-06
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
HRP20200006T1 (hr) 2020-03-20
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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