Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1997-07-07
1998-11-10
Tsang, Cecilia J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
530382, 530383, A61K 3514, C07K 100, C07K 1400, C07K 1700
Patent
active
058344209
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/BE95/0069.
SUBJECT OF THE INVENTION
The present invention relates to a fibrinogen concentrate obtained from human or animal blood plasma and to the process for its preparation, as well as to the plant for preparing the said fibrinogen concentrate.
The present invention furthermore relates to the pharmaceutical and/or cosmetic composition which comprises the said fibrinogen concentrate.
TECHNOLOGICAL BACKGROUND UNDERLYING THE INVENTION
Fibrinogen is a plasma protein which is of fundamental importance in the coagulation process, and its areas of pharmaceutical or cosmetic application cover a variety of fields (wound healing, coagulating agent, constituent of biological adhesives, fibrinogenaemia, inhibition of operative and post-operative sequelae, etc.).
Making blood proteins such as fibrinogen available requires, for the said proteins to be used for therapeutic or non-therapeutic purposes, purification techniques which make it possible to obtain products which are of high purity and completely free from viral contaminants (HIV, hepatitis viruses, parvovirus, etc.) or from biological molecules such as antibodies or proteases (65/65 EEC, 75/319/EEC & 89/381 EEC Council Directives).
For this reason, various treatment methods (filtration, precipitation, affinity chromatography, etc.) have been proposed for eliminating or inactivating plasma contaminants and/or compounds which are derived from the plasma (factor VIII, von Willebrand factor, fibronectin, etc.).
The treatments for inactivating viruses may consist of a thermal treatment or a chemical treatment.
A chemical treatment may, for example, consist of a viral inactivation which is brought about by using a solvent/detergent such as described in Patent Application No. EP-0 131 740.
However, these thermal or chemical treatments for inactivating viruses do not completely eliminate some viral contaminants, in particular some non-enveloped viruses such as parvovirus B19.
STATE OF THE ART
Patent Application PCT/FR89/00050 (WO89/12065) describes such a viral inactivation using a solvent/detergent in a process for separating plasma proteins from a solubilized fraction of a plasma cryoprecipitate.
According to this process, the fraction of a plasma cryoprecipitate, which fraction is resolubilized in water, is subjected to a solvent/detergent viral inactivation treatment and then to a single chromatographic separation on an anion exchange resin whose matrix is a gel which is able, by virtue of its porosity and hydrophobicity properties, to retain the factor VIII/von Willebrand factor complex. Each of the proteins is then recovered selectively by means of successive increases in the ionic strength of the elution buffer.
While the first filtrate from the chromatography principally contains fibrinogen, it also contains albumin, immunoglobulins and viral inactivation agents (Tween and TNBP).
Using this solution, the fibrinogen is then purified (elimination of the viral inactivation agents) by means of a fresh chromatography step on a column of heparin/sepharose resin.
The collected fibrinogen fraction is then concentrated and dialysed using a cassette system. The concentrated product is apportioned into bottles and lyophilized.
However, this technique for purifying fibrinogen suffers from the drawback that it requires a chromatographic purification step which is both complex and expensive.
Furthermore, this purification technique does not allow substantial volumes of fractions which are enriched in high-purity fibrinogen to be treated rapidly on an industrial scale. Again, the fibrinogen concentrate which is purified by means of an additional chromatographic step will lack factor XIII, thereby making it less useful as a biological adhesive.
Patents and Patent Applications DE-30 01 435, EP-0 311 950 and PCT/GB86/00121 (WO86/05190) describe processes for purifying blood compounds derived from blood plasma fractions by means of precipitation at acid pH and in the presence of an amino acid.
These processes can be combined with a che
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patent: 4295855 (1981-10-01), Sasaki
patent: 4297344 (1981-10-01), Schwinn et al.
patent: 4789733 (1988-12-01), Winkelmann
patent: 5099003 (1992-03-01), Kotitschke
patent: 5252709 (1993-10-01), Burnouf
De Wael Luc
Laub Ruth
Croix-Rouge de Belgique
Marshall S. G.
Tsang Cecilia J.
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