Reversed Micellar Fractionation of Recombinant-DNA Therapeutic Protein Intermediates

Bio-Eng正在开发一种连续流动反胶束-有机相(RM-ORG)工艺，用于从发酵液中获得重组DNA治疗蛋白中间体的初始分离或纯化。建议的RM-ORG过程不会与高分辨率层析纯化步骤竞争，而是补充高分辨率层析纯化步骤。通过减少高分辨率层析纯化步骤的负荷，RM-ORG分级法将提高生产能力，从而减少生产时间和成本。在特异性(2到10倍)和高产率(95%到100%)方面预计会有适度到高度的改进。还预计了RM-ORG工艺的其他固有好处，如工艺流澄清、浓缩和缓冲液交换。与现有的初级纯化工艺相比，RM-ORG的潜在优势包括选择性、处理速度、保持蛋白质完整性和可扩展性。

Bio-Eng is developing a continuous flow reversed micellar-organic phase (RM-ORG) process for the initial fractionation or purification of recombinant-DNA therapeutic protein intermediates which are harvested from a fermentation broth. The proposed RM-ORG process will not compete with, but will rather complement high resolution chromatographic purification steps. RM-ORG fractionation would increase throughput capacity by reducing the loading on higher resolution chromatographic purification steps, and would thus reduce production time and costs. Modest to high improvements in specificity (2 to 10 fold) and high yields (95 to 100%) are anticipated. Other intrinsic benefits to the RM-ORG process such as process stream clarification, concentration and buffer exchange are also anticipated. Potential advantages of RM-ORG over existing primary purification processes include selectivity, speed of processing, preservation of protein integrity, and scalability.