FRACTIONATION OF PLASMA BY FILTRATION & ULTRAFILTRATION

由于正常血清的安全性和有效性的优异记录 白蛋白在过去40年中，它是安全的假设，在可预见的 未来，冷乙醇分馏系统仍将是 从血浆中制备该临床产品的选择。 任何新的或 分离这种蛋白质的改良方法必须建立在 乙醇分馏的现有方案。 由于这些显而易见的 因此，我们应该限制自己在现有的改善， 该过程将通过以下方式提高生产的盈利能力 简化工艺和/或提高产率。 这项研究建议的长远目标是解决 简化的过程，并在产量的增加，基于一个 冷乙醇程序的简化版本，使用 专门的过滤和超滤技术。 过滤将是 试图取代现有的离心和过滤步骤， 获得馏分IV-4滤液，并尝试超滤， 取代馏分V沉淀、V返工过滤的现有步骤 再沉淀、冻干和复溶，以制备最终的 白蛋白溶液。 预计这一简化过程将不会 仅产生至少具有相同质量的白蛋白制剂 与常规分馏所得的相同，而且由于 减少分馏步骤，从而减少处理损失， 回收母液的能力，否则母液被截留在 沉淀物。

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.