Abstract: Disclosed is a method for preparing a composition comprising factor VIII (FVIII) and von Willebrand factor (vWF), wherein the content of the von Willebrand factor (vWF) can be controlled by mixing the factor VIII (FVIII) with the von Willebrand factor (vWF) at an appropriate ratio after separately purifying the factor VIII (FVIII) and the von Willebrand factor (vWF) from plasma in a single process. The method can prepare and purify a composition comprising factor VIII (FVIII) and a varying content of von Willebrand factor (vWF) without increasing the amount of impurities other than the von Willebrand factor (vWF) compared to a method of purifying factor VIII (FVIII) separately, without significantly increasing the processing time (within 3 hours) compared to a method of purifying factor VIII (FVIII), and without changing the yield of factor VIII (FVIII).

Abstract: A method for purifying fibrinogen includes steps of: (a) precipitating fibrinogen of a fibrinogen-containing solution by adding glycine to the solution for a concentration of glycine to be 1.5 to 2.5M, and then removing a supernatant and recovering a precipitate (1st glycine precipitation); (b) dissolving the precipitate of 1st glycine precipitation of step (a) in a dissolution buffer to obtain a solution, precipitating the solution by adding glycine thereto for a concentration of glycine to be 0.2 to 1.2M, and recovering a supernatant (2nd glycine precipitation); (c) precipitating the supernatant of step (b) by adding glycine thereto for a concentration of glycine to be 1.5 to 2.5M, and recovering a precipitate (3rd glycine precipitation); and (d) dissolving the precipitate of step (c) in a dissolution buffer to obtain a solution, and subjecting the solution to nanofiltration using a nanofilter.

Abstract: A method for preparing a highly concentrated fibrinogen solution includes adding amino acid or amino acid derivatives, and/or salts to a lowly concentrated fibrinogen solution, followed by a ultra-filtration concentration. Factor XIII can be added either before or after the ultra-filtration to give a fibrin sealant component 1 containing the highly concentrated fibrinogen solution. The fibrin sealant component 1 could be preserved for a long time at room temperature and be used without a reconstitution. Fibrin sealant component 2 is a solution containing thrombin and calcium. A fibrin sealant product may be provided in a vial type in which the fibrin sealant components 1 and 2 are each filled in separate vials or in a re-filled syringe type wherein the fibrin sealant components 1 and 2 are each filled in separate syringes connected with each other to be instantly used.

Abstract: The present invention relates to a method for purifying an immunoglobulin, and more particularly, to a method for purifying an immunoglobulin, which comprises: dissolving immunoglobulin-containing plasma protein fraction I+II+III or fraction II+III; adding caprylate to the solution to cause precipitation; performing dialysis and concentration after removal of the precipitate; performing anion exchange resin and ceramic cation exchange resin purification processes to effectively remove a solvent and detergent added to inactivate viruses; and performing elution while maintaining salt concentration at a constant level to maintain the immunoglobulin polymer content at a low level.

Abstract: The present invention relates to a preparation method of a human plasma-derived hepatitis B immunoglobulin preparation. More specifically, the present invention relates to a preparation method of a human plasma-derived hepatitis B immunoglobulin preparation characterized in that plasma protein fraction II (fraction II) containing human hepatitis B immunoglobulin is dialysis concentrated and then thrombus-producing materials and impurities formed during processes are removed by anion exchange resin and cation exchange resin purification techniques. By using the preparation method of the human plasma-derived hepatitis B immunoglobulin preparation according to the present invention, the efficiency of removing impurities and thrombus-producing materials is increased and a polymer content is maintained, whereby it is possible to produce human hepatitis B immunoglobulin with stable and improved quality.

Abstract: The present invention relates to a method for purifying an immunoglobulin, and more particularly, to a method for purifying an immunoglobulin, which comprises: dialyzing and concentrating an immunoglobulin-containing plasma protein fraction II paste; removing thrombotic substances from the dialyzed and concentrated fraction by a purification process using ceramic cation exchange resin; and performing elution while maintaining salt concentration at a constant level to maintain the polymer content of the immunoglobulin at a low level. When the immunoglobulin purification method according to the present invention is used, the efficiency with which impurities and thrombotic substances are removed can be increased and the polymer content of the immunoglobulin can be maintained, and thus a stable immunoglobulin with improved quality can be produced.

Abstract: A method for purifying fibrinogen includes steps of: (a) precipitating fibrinogen of a fibrinogen-containing solution by adding glycine to the solution for a concentration of glycine to be 1.5 to 2.5M, and then removing a supernatant and recovering a precipitate (1st glycine precipitation); (b) dissolving the precipitate of 1st glycine precipitation of step (a) in a dissolution buffer to obtain a solution, precipitating the solution by adding glycine thereto for a concentration of glycine to be 0.2 to 1.2M, and recovering a supernatant (2nd glycine precipitation); (c) precipitating the supernatant of step (b) by adding glycine thereto for a concentration of glycine to be 1.5 to 2.5M, and recovering a precipitate (3rd glycine precipitation); and (d) dissolving the precipitate of step (c) in a dissolution buffer to obtain a solution, and subjecting the solution to nanofiltration using a nanofilter.

Abstract: The present invention relates to a preparation method of a human plasma-derived hepatitis B immunoglobulin preparation. More specifically, the present invention relates to a preparation method of a human plasma-derived hepatitis B immunoglobulin preparation characterized in that plasma protein fraction II (fraction II) containing human hepatitis B immunoglobulin is dialysis concentrated and then thrombus-producing materials and impurities formed during processes are removed by anion exchange resin and cation exchange resin purification techniques. By using the preparation method of the human plasma-derived hepatitis B immunoglobulin preparation according to the present invention, the efficiency of removing impurities and thrombus-producing materials is increased and a polymer content is maintained, whereby it is possible to produce human hepatitis B immunoglobulin with stable and improved quality.

Abstract: The present invention relates to a method for purifying an immunoglobulin, and more particularly, to a method for purifying an immunoglobulin, which comprises: dissolving immunoglobulin-containing plasma protein fraction I+II+III or fraction II+III; adding caprylate to the solution to cause precipitation; performing dialysis and concentration after removal of the precipitate; performing anion exchange resin and ceramic cation exchange resin purification processes to effectively remove a solvent and detergent added to inactivate viruses; and performing elution while maintaining salt concentration at a constant level to maintain the immunoglobulin polymer content at a low level.