Albumin (Human) 25%, USP (Plasbumin-25) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration.
Plasbumin-25 is a 25% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.02 M sodium caprylate and 0.02 M acetyltryptophan. The aluminum content of the product is not more than 200 μg/L. The approximate sodium content of the product is 145 mEq/L. It contains no preservative. Plasbumin-25 must be administered intravenously.
Each vial of Plasbumin-25 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. The production steps from Pooled Plasma to Effluent IV-1 in the Plasbumin-25 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.