NO20053677L - Process for the preparation of albumin - Google Patents

Process for the preparation of albumin

Info

Publication number
NO20053677L
NO20053677L NO20053677A NO20053677A NO20053677L NO 20053677 L NO20053677 L NO 20053677L NO 20053677 A NO20053677 A NO 20053677A NO 20053677 A NO20053677 A NO 20053677A NO 20053677 L NO20053677 L NO 20053677L
Authority
NO
Norway
Prior art keywords
stabilizer
optionally
albumin
albumin solution
groups
Prior art date
Application number
NO20053677A
Other languages
Norwegian (no)
Other versions
NO20053677D0 (en
Inventor
Werner Gehringer
Katharina Pock
Tor-Einar Svae
Christoph Kannicht
Juergen Romisch
Original Assignee
Octapharma 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 Octapharma Ag filed Critical Octapharma Ag
Publication of NO20053677D0 publication Critical patent/NO20053677D0/en
Publication of NO20053677L publication Critical patent/NO20053677L/en

Links

Classifications

    • 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
    • A61K38/38Albumins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P7/08Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

Det beskrives et terapeutisk anvendelig virusinaktivert albumin og en fremgangsmåte for fremstilling av terapeutisk anvendelig virusinaktiverte albuminer som kjennetegnes ved kombinasjonen av følgende trinn: (a) underkastelse av en første vandig albuminløsning en behandling for virusinaktivering etter SD-metoden gjennom kontakt med SD-reagenser ved en temperatur under 45°C, (b) fjerning av SD-reagensene ved oljeekstraksjon og påfølgende hydrofob interaksjonskromatografi, i det minste i det vesentlige, hvorunder det under kromatograferingen benyttes en hydrofob matriks, særlig en matriks som eventuelt hydrofobe grupper kan være bundet til, under den forutsetning at disse gruppene er alifatiske grupper med C>24, og hvor det oppnås en andre albuminløsning, som (c) eventuelt tilsettes én eller flere stabilisatorer innen gruppen sukker, aminosyrer og sukkeralkoholer, under forutsetning av at det som stabilisator ikke benyttes noen indol-stabilisator og ingen C6-C10-fettsyre, hvoretter (d) den andre, eventuelt stabilisator-tilsatte, albuminiøsning, sluttbehandles og sterilfiltreres og eventuelt påfylles den endelige beholder.A therapeutically useful virus-inactivated albumin is disclosed and a process for the preparation of therapeutically useful virus-inactivated albumins characterized by the combination of the following steps: (a) subjecting a first aqueous albumin solution to a virus inactivation treatment by SD method through contact with SD reagents by a (b) removing the SD reagents by oil extraction and subsequent hydrophobic interaction chromatography, at least substantially, during which a hydrophobic matrix, in particular a matrix to which hydrophobic groups may be attached, is used, during provided that these groups are aliphatic groups with C> 24 and where a second albumin solution is obtained, which (c) optionally one or more stabilizers are added within the group of sugars, amino acids and sugar alcohols, provided that no stabilizer is used as a stabilizer. stabilizer and no C6-C10 fatty acid, respectively (d) the other, optionally stabilizer added, albumin solution is final treated and sterile filtered and optionally refilled to the final container.

NO20053677A 2003-02-13 2005-07-29 Process for the preparation of albumin NO20053677L (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT2182003 2003-02-13
PCT/EP2004/001397 WO2004071524A1 (en) 2003-02-13 2004-02-13 Albumin solution and method for the production thereof

Publications (2)

Publication Number Publication Date
NO20053677D0 NO20053677D0 (en) 2005-07-29
NO20053677L true NO20053677L (en) 2005-10-31

Family

ID=32854882

Family Applications (1)

Application Number Title Priority Date Filing Date
NO20053677A NO20053677L (en) 2003-02-13 2005-07-29 Process for the preparation of albumin

Country Status (22)

Country Link
EP (1) EP1592439B1 (en)
JP (1) JP2006517938A (en)
KR (1) KR20050103292A (en)
CN (1) CN100384471C (en)
AT (1) ATE362376T1 (en)
AU (1) AU2004212324B2 (en)
BR (1) BRPI0407458A (en)
CA (1) CA2514163A1 (en)
CY (1) CY1106793T1 (en)
DE (1) DE502004003834D1 (en)
DK (1) DK1592439T3 (en)
ES (1) ES2285427T3 (en)
IL (1) IL169828A0 (en)
MX (1) MXPA05008276A (en)
NO (1) NO20053677L (en)
PL (1) PL376644A1 (en)
PT (1) PT1592439E (en)
RS (1) RS50891B (en)
RU (1) RU2305556C2 (en)
UA (1) UA80469C2 (en)
WO (1) WO2004071524A1 (en)
ZA (1) ZA200506452B (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005023155A1 (en) * 2005-05-13 2006-11-16 Albutec Gmbh albumin solution
JP2009520714A (en) * 2005-12-22 2009-05-28 ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー Low octanoate human albumin
ES2332846B1 (en) 2007-10-26 2010-07-08 Grifols, S.A. USE OF THERAPEUTIC HUMAN ALBUMIN FOR THE PREPARATION OF A MEDICINAL PRODUCT FOR THE TREATMENT OF PATIENTS AFFECTED BY COGNITIVE DISORDERS.
ES2294976B1 (en) * 2007-11-12 2008-12-16 Grifols, S.A. "HIGH EFFECTIVE HUMAN ALBUMIN OBTAINING PROCEDURE FOR USE IN DETOXIFICATION THERAPY".
EP2382993A1 (en) 2010-04-19 2011-11-02 KTB Tumorforschungsgesellschaft mbH Combination of drugs with protein-binding prodrugs
CN111195351A (en) * 2020-01-20 2020-05-26 华兰生物工程重庆有限公司 Preparation method of 5% low-concentration human serum albumin

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2190436B1 (en) * 1972-07-05 1975-06-20 Merieux Inst
SU1212416A1 (en) * 1984-04-03 1986-02-23 Научно-Исследовательский Институт Гематологии И Переливания Крови Им.Проф.Р.О.Еоляна Method of extracting albumin from blood plasma
JPH0669961B2 (en) * 1984-09-25 1994-09-07 株式会社ミドリ十字 Immunoglobulin heat treatment method
US5094960A (en) * 1988-10-07 1992-03-10 New York Blood Center, Inc. Removal of process chemicals from labile biological mixtures by hydrophobic interaction chromatography
US5250662A (en) * 1989-10-05 1993-10-05 Alpha Therapeutic Corporation Albumin purification
RU2007423C1 (en) * 1991-06-04 1994-02-15 Институт биофизики клетки РАН Method of serum albumin purification
DE19729778A1 (en) * 1997-07-11 1999-01-21 Blutspendedienst Der Drk Lande Process for the preparation of virus-inactivated biological fluids
US5919907A (en) * 1997-12-22 1999-07-06 Shanbrom Technologies Llc Preparation and utilization of a novel sterile albumin
IL136552A (en) * 2000-06-05 2005-05-17 Omrix Biopharmaceuticals Ltd Method for the inactivation of viruses by a solvent - detergent combination and by nanofiltration

Also Published As

Publication number Publication date
CY1106793T1 (en) 2012-05-23
ZA200506452B (en) 2007-01-31
ES2285427T3 (en) 2007-11-16
CN1798573A (en) 2006-07-05
KR20050103292A (en) 2005-10-28
ATE362376T1 (en) 2007-06-15
CA2514163A1 (en) 2004-08-26
AU2004212324A1 (en) 2004-08-26
RS20050624A (en) 2007-06-04
AU2004212324B2 (en) 2009-05-07
CN100384471C (en) 2008-04-30
RS50891B (en) 2010-08-31
DE502004003834D1 (en) 2007-06-28
EP1592439A1 (en) 2005-11-09
PL376644A1 (en) 2006-01-09
UA80469C2 (en) 2007-09-25
PT1592439E (en) 2007-06-22
BRPI0407458A (en) 2006-01-31
MXPA05008276A (en) 2006-03-21
RU2005128507A (en) 2006-01-20
DK1592439T3 (en) 2007-09-10
JP2006517938A (en) 2006-08-03
EP1592439B1 (en) 2007-05-16
WO2004071524A1 (en) 2004-08-26
RU2305556C2 (en) 2007-09-10
IL169828A0 (en) 2011-08-01
NO20053677D0 (en) 2005-07-29

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