Interferons and interleukins have been major players in the important field of viral, infectious, and tumorial immunology. Genetic engineering has made available large quantities of lymphokines through high level expression in mammalian and bacterial cells. The simple and rapid purification of recombinant-DNA lymphokines has been a major obstacle to the lowering of manufacturing costs which are often realized from economies-of-scale in commercial operations. Purification of these minor components by existing processes require multiple steps which are costly, time consuming and often result in poor recovery. We propose to develop an improved and scalable process for the purification of recombinant-DNA produced lymphokines which are harvested from a fermentation broth or a mammalian cell culture. We plan to achieve this goal by utilizing novel two-phase or biphasic aqueous polymer systems. The proposed process is targeted for the primary purification or initial fractionation of the harvested lymphokines. The proposed research is intended to develop a large scale manufacturing process for the rapid purification of biosynthetic lymphokines. Potential advantages over existing methods include speed of processing, preservation of protein integrity, non-toxicity, high selectivity, speed of processing, ready scalability, amenability to continuous operation and significantly reduced manufacturing costs.
