Reversed Micellar Fractionation of Recombinant-DNA Therapeutic Protein Intermediates

Bio-Eng正在开发一种连续流动逆转胶束有机相（RM-ORG）工艺，用于从发酵液中收获的重组dna治疗性蛋白质中间体的初始分离或纯化。提议的RM-ORG过程不会与高分辨率色谱纯化步骤竞争，而是补充。RM-ORG分馏将通过减少高分辨率色谱纯化步骤的负载来增加吞吐量，从而减少生产时间和成本。预期在特异性（2 - 10倍）和高产量（95 - 100%）方面有中度到高度的改善。RM-ORG工艺的其他内在好处，如工艺流澄清、集中和缓冲交换也被预期。RM-ORG相对于现有初级纯化工艺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.