Method of manufacturing and purifying prothrombin complex concentrate from Fraction III for intravenous injection and a method of curing and preventing Hemophilia A with inhibitors or Hemophilia B in 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.