METHOD OF MANUFACTURING AND PURIFYING PROTHROMBIN COMPLEX CONCENTRATE FROM FRACTION III FOR INTRAVENEOUS INJECTION AND A METHOD OF CURING AND PREVENTING HEMOPHILIA A WITH INHIBITORS OR HEMPOPHILIA B PATIENTS INFECTED WITH HIV-1 AND HIV-2
The present subject matter is directed to a method of manufacturing and purifying an intraveneous injection of prothrombin complex concentration (PCC) from plasma Fraction III, comprising reconstituting a Fraction III paste in a buffer to create a Fraction III suspension； adjusting pH and temperature of the Fraction III suspension； performing PEG precipitation； centrifuging the Fraction III suspension and collecting a supernatant； filtering the supernatant； performing solvent detergent virus inactivation of the supernatant； undergoing weak anion exchange chromatography of the supernatant； twice washing and eluting two to three times； ultra-filtering the supernatant； adjusting pH of the supernatant； adjusting activity of a human factor IX of the supernatant； performing aseptic filtration and nano filtration for virus removal； and filling and lyophilizing to obtain the intraveneous injection of PCC.
