An overview of types of technology transfer (TT) from development to validation of the lyophilized product is discussed. A detailed consideration of various activities that must be performed for successful TT of lyophilized product is provided. Evaluation of functional equivalency among lyophilizers as a tool in transfer of lyophilization cycles is reviewed and described. Such approach provides the basis to establish functional equivalence among different lyophilizers. Once established, functional equivalence can facilitate successful implementation of scale-up and transfer of lyophilization cycles. Such equivalency procedures are desirable in large manufacturing operations, where multiple lyophilizers are used for processing a common lyophilized product, and reduced validation campaigns based upon a matrix approach can save considerable resources and time.
