(69b) GMP Implementation of Continuous Manufacturing: A Case Study

Continuous processing is being explored in various ways throughout the biopharmaceutical industry. New process technologies and business considerations are driving process design towards more agile, modular, and highly productive paradigms. Continuous manufacturing provides potential benefits such as reduced process scale and the implementation of single-use technologies. However, these benefits may come at the cost of complexity.

This presentation will review a case study analyzing the conversion of a traditional GMP process into a continuous manufacturing paradigm. Discussion will include the development of integrated continuous operations, control strategy, and process design considerations. The outcomes of the process conversion will also be discussed.