Lu Xiu-Ling, Su Zhi-Guo
National Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, PO Box 353, Beijing 100080, China.
Sheng Wu Gong Cheng Xue Bao. 2002 Nov;18(6):761-6.
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.
人血清白蛋白（HSA）已在临床上大剂量用于治疗多种疾病。大规模生产需要极高纯度的产品。长期以来，血浆来源的HSA（pHSA）一直通过沉淀法生产。其中冷乙醇沉淀法占主导地位。然而，在过去几年中，HSA的色谱纯化研究越来越多。色谱法的应用，尤其是离子交换、亲和和尺寸排阻色谱法，为pHSA的生产开辟了一个新领域。一个新的挑战是重组HSA（rHSA）的纯化。一种成功的方法是采用STREAMLINE扩张床吸附技术直接从发酵液中捕获目标产物。这种新工艺无需通过离心或膜过滤来分离细胞。离子交换色谱法和疏水色谱法在纯化方案中起着核心作用。与其他色谱技术如尺寸排阻、金属螯合和亲和色谱法相结合可提高纯化效果。尽管具有创新性，但rHSA的纯化仍需进一步改进和优化，以提高产品纯度和工艺回收率。
