PROCESS DEVELOPMENT AND PROCESS ENGINEERING A KEY ROLE IN ENABLING CELL THERAPIES

In the last decade, it has been proven that cell therapy works in the lab, in preclinical settings and in small scale clinical trials. The need for large quantities of cells with high quality becomes crucial as product candidates advance into clinical trials and market authorization. Most of the manufacturing technologies of cell therapy are based on manual lab technologies and present inherited cGMP challenge. Additionally, manual processes endangers the products quality and sterility and result in high cost of goods which in turn will limit the use of the therapies in the clinic. Biotechnology engineers are facing new challenges of defining the critical process elements to be redesigned, building technologies for products with a unique characterization in an evolving regulatory environment. This challenge must be addressed in a systematic and creative manner. Additionally, as the new and outstanding data of autologous cell therapy emerges and approaches the market, the process engineering task becomes more complex and will be the main driver to enable the therapy commercially. The talk will describe the main challenges facing the industry and describe a systematic engineering approach to overcome the challenges. The talk will use real examples of developments in the field of cell therapy and immune cell therapy and provide the basic approach guideline for process development in view of the target product profile understanding.