Drawbacks of Batch Processing, Current Status, and Perspectives

Continuous manufacturing is becoming increasingly important in the pharmaceutical industry, and lyophilization, as a downstream process, is actively involved in the process of transition from batch to continuous. This chapter summarizes the main drawbacks of batch lyophilization and their impact on the production of pharmaceutical and biotech drugs, as well as the potential advantages resulting from the application of continuous manufacturing strategies. Attention is then given to three recent technologies, which have a great deal of potential to improve the quality and uniformity of the finished products and enhance process efficiency and profitability.