Because of the excellent record of safety and efficacy of normal serum albumin in the past 40 years, it is safe to assume that, in the foreseeable future, cold ethanol fractionation system will remain as the method of choice for preparing this clinical product from plasma. Any new or modified procedure to isolate this protein will have to be built into the existing scheme of the ethanol fractionation. Due to these obvious reasons, we should restrict ourselves in the improvements of the existing process which will increase the profitability of the production by simplifying the process and/or increasing the yield. The long-term objective of this research proposal is to address the simplification of the process, and the increase in yield, based on a simplified version of the cold ethanol procedure, to prepare albumin using exclusively filtration and ultrafiltration techniques. Filtration will be attempted to replace the existing centrifugation and filtration steps to obtain the Fraction IV-4 filtrate, and ultrafiltration will be attempted to replace the existing steps of Fraction V precipitation, V Rework filtration and reprecipitation, lyophilization and reconstitution, to prepare final albumin solutions. It is anticipated that this simplified process will not only result in an albumin preparation which is at least of the same quality as that obtained by routine fractionation, but also improve the yield due to less fractionation steps thus resulting less handling losses, and the ability to recover the mother liquor which is otherwise entrapped in the precipitate.
