A METHOD OF MANUFACTURING AND PURIFIYING 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

摘要

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.