人血清白蛋白纯化技术研究进展

本文综述了国内外关于血浆人血清白蛋白（pHSA）和基因重组人血清白蛋白（rHSA）分离纯化的进展和发展趋势。以冷乙醇沉淀为主的pHSA分离方法仍是目前多数工业采用的工艺，但近年来发展的离子交换色谱、凝胶过滤色谱、亲和色谱等多种色谱分离技术具有自动化程度高、生产周期短、更符合GMP等特点，正在逐步取代传统的冷乙醇沉淀法。当前用基因工程技术表达的人血清白蛋白对分离纯化提出了新的挑战。为获得高纯度、安全、稳定的产品，各种色谱分离技术得到更多的应用，其中扩张床离子交换色谱可以省去离心、过滤等传统固液分离操作。尽管rHSA的纯化技术已有一定的发展，但纯化过程仍需进一步优化以提高产品纯度及收率。

Progress in putification of Human Serum Albumin

Human serum albumin(HSA) has been used clinically to treat a number of diseases with high dosage. Extremely pure puoduct is required in large-scale production. Plasma-derived HSA(pHSA) has long been produced by precipitation methods. Among them cold ethanol precipitation is dominant. However, chromatographic purification of HSA has been increasingly studied in the last few years. Application of chromatography, especially ionexchange, affinity, and size-exclusion, has opened a new area in the production of pHSA. A new challenge is the purification of recombinant HSA(rHSA). A successful approach involves STREAMLINE expanded bed adsorption to direct capture the target product from the fermentation broth. This novel process eliminates the need to separate the cells by centrifugation or membrane filtration. Ion exchange chromatography and hydrophobic chromatography play a central role in the purification scheme. Integration with other chromatographic techniques such as size-exclusion, metal chelate, and affinity gives improved purification results. Though innovative, the purification of rHSA still needs further improvement and optimization to increase product purity and process recovery.