STERILIZATION OF RECOMBINANT HUMAN SERUM ALBUMIN PREPARATION
PURPOSE:To exterminate various microorganisms existing in a recombinant human serum albumin preparation obtained by gene manipulation by heating the preparation under specific condition. CONSTITUTION:A recombinant human serum albumin(rHSA) preparation obtained by gene manipulation and filled in a co...
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Zusammenfassung: | PURPOSE:To exterminate various microorganisms existing in a recombinant human serum albumin preparation obtained by gene manipulation by heating the preparation under specific condition. CONSTITUTION:A recombinant human serum albumin(rHSA) preparation obtained by gene manipulation and filled in a container in an amount corresponding to the unit dose is heat-treated at 50-70 deg.C for >=30min, preferably at 60 deg.C for 30min to 2hr. Microorganisms existing in the rHSA preparation are exterminated by this treatment to obtain an rHSA preparation having extremely high safety. The rHSA preparation can be used, similar to a plasma-originated HSA preparation, as an injection for the quick increase of plasma, supplementation of circulation blood, improvement of hypoproteinemia, maintenance of colloid osmotic pressure, etc., and is useful for the treatment of hypoalbuminemia, hemorrhagic shock, etc. |
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