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Adoption of Controlled Ice Nucleation Technology, ControLyo®
Abstract: Stabilization by lyophilization is attractive to retain a drug product’s potency, structural integrity and homogeneity, all of which are crucial to the success of a pharmaceutical product. Lyophilization begins by lowering the temperature of the product to below its freezing point to form ice crystals (nucleation). However, this process is random and often results in heterogeneity and poor product reconstitution. This article describes various techniques used to control ice nucleation which have been widely used in research and development environments, and demonstrate its use in production manufacturing. It will focus on one of these methods, ControLyo® which uses a pressurization and depressurization technique to provide simultaneous ice nucleation. The advantages of implementing ControLyo will be discussed including its role in creating a smooth transition between lab- and commercial- scale lyophilization.