Abstract: The present invention describes the integration of preparative crystallization, crystal separation, crystal washing and freeze-drying processes of insulin and insulin analogues into single continuous process using pressure filtration. The process facilitates time reduction and outlines the novel design of using multiple organic solvent washes and nitrogen gas purging for the removal of imbibed water and achieve final drug substance that meets the quality specifications.

Abstract: The present invention discloses a method for crystallizing recombinant Human Insulin at lab and manufacturing scale in the presence of zinc chloride and sodium chloride mixture, higher concentration of organic solvent (IPA—19 to 25 million) and adjusting the pH to 5.0 at a faster rate (?5 minutes). The method further comprises adopting procedures wherein the settling time is reduced and the holding temperature is altered in order to facilitate consistent protein crystal formation between 15 ?m-30 ?m and to increase the robustness of the process.

Abstract: The present invention describes the integration of preparative crystallization, crystal separation, crystal washing and freeze-drying processes into single continuous process using pressure filtration. The process facilitates time reduction, and outlines the novel design of using multiple organic solvent washes and nitrogen gas purging for the removal of imbibed water and achieve final drug substance that meets the quality specifications.