Centre Regional De Transfusion Sanguine De Lille

Asahi Kasei Medical Co., Ltd.

Association Pour L'essor De La Transfusion Sanguine Dans La Region Du

Thierry Burnouf

Miryana Burnouf-Radosevich

Dominique Dernis

Catherine Michalski

Hadi Alphonse Goubran

Tetsuo Sato

Patrick Bonneel

Sakae Sato

Miryana Radosevich

The present invention relates to a plasma product or a serum product with an extremely low risk of viral contamination and a method for producing the same. Before treating plasma or serum to be used as a raw material for producing a plasma product or a serum product using a virus removal membrane, leucocytes contaminating the blood are removed. Thus, a plasma product or a serum product with an extremely low risk of viral contamination can be efficiently produced while preventing clogging. Since clogging scarcely arises, it is possible to carry out efficient filtration without applying an elevated pressure as the filtration proceeds.

Viral reduction method for plasma using a leukocyte-reduction filter and two virus-reduction filters of decreasing pore diameters

Immunoglobulin G concentrate for therapeutic use and process for

The invention relates to a process for preparing purified albumin from a human or animal physiological solution, such as a plasma or a plasma fraction. The process includes a process of delipidation using an anionic detergent and two chromatographic separation stages using ion-exchange resin. By applying the process according to the invention, it is possible to obtain an albumin solution of great purity, that is stable and suitable for therapeutic use.

Process for the preparation of purified albumin solutions

The invention relates to a process for preparing a concentrate of Factor VIII-von Willebrand factor complex having high specific activity from total (non-cryoprecipitated) plasma. The process comprises pre-purifying by means of a double treatment with barium chloride and with aluminium hydroxide. The process then comprises purification by chromatography on an anion exchange resin, of the DEAE-Fractogel type. The process includes a step of viral inactivation by means of a treatment with solvent-detergent. The process also makes it possible to recover fibrinogen, albumin, immunoglobulins, antithrombin III, fibronectin and prothrombin complex, from the same plasma. The different concentrates obtained using the process according to the invention are intended, in particular, for therapeutic use.

Process for preparing a concentrate of blood coagulation factor VIII-von

The present invention relates to a method for preparing a high purity Factor IX concentrate. The starting material for the process is the supernatant fraction of a cryoprecipitated human plasma. A pre-purification step is performed by DEAE-Sephadex chromatography. The resulting Factor IX fraction has a specific activity of at least 0.5 IU/mg protein. The purification method of the invention comprises two successive chromatography separations. First, ion-exchange chromatography on DEAE-sepharose is conducted so that the Factor IX is eluted when the ionic force of the buffer is increased to 0.34-0.38M sodium chloride. Then, affinity chromatography is conducted on heparin-sepharose. The elution buffer is a citrate buffer at a pH of 7.4 adjusted with 0.45M sodium chloride and supplemented with arginine as a stabilizer for Factor IX activity. Lysine is added as a stabilizer before freeze-drying of the purified Factor IX.

Preparation of a high-purity human factor IX concentrate and other

The invention relates to a process for purifying human von Willebrand factor from a cryoprecipitated plasma fraction, which comprises a combination of three chromatographic separation steps. The first chromatographic separation step comprises contacting a cryoprecipitated fraction with a large-pore vinyl polymer resin having DEAE group. The effluent from this separation step is again contacted with a large pore vinyl polymer resin having DEAE groups in the second chromatographic step. In the third chromatographic separation step, the effluent from the second step is subjected to affinity chromatography by contacting with gelatin-Sepharose. The concentrate obtained has very high specific activity and a high percentage of high molecular weight multimers. The concentrate is intended, in particular, for therapeutic use.

Process for an industrial-scale preparation of a standardized human von

The invention provides a thrombin coagulable protein concentrate,, the preparation thereof and the therapeutic use thereof. This concentrate has a fibrinogen content greater than 70% and a sufficient amount of endogenous Factor XIII. It may be solubilized at ambient temperature. Its preparation comprises at least one cold precipitation step with dilute ethanol and uses total plasma as a starting product. The concentrate of the invention makes it possible more particularly to obtain an injectable fibrinogen and a biological glue of high quality.

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Wavrin, France

Thierry Burnouf