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.
