Guide To Transitioning Clinical Cell Therapy Manufacturing To Commercial Scale

The manufacturing needs of cell and gene therapy (CGT) change drastically throughout the developmental cycle. Flexibility is needed during the research and development stage while robustness, scalability and leanness are critical for the clinical stages and ultimately commercial production. More and more CGT manufacturers are focusing on automating and closing unit processes earlier in the developmental cycle. This saves significant time, increases efficiency and reduces cost.

Automation has drastically improved commercial CGT manufacturing, and it is becoming more widespread in clinical manufacturing as well. In the clinical phases, automation can significantly reduce the time and money required to supply large trials and demonstrate an effective, robust process that can be scaled upon market approval. More importantly, filing for approval with the processes that will be used for commercial manufacturing can ease the transition to commercial-scale manufacturing.

The significance of the organizational change required to transition from clinical-scale manufacturing to commercial scale should not be underestimated. In this paper, we discuss the automation strategies that CGT manufacturers should consider during this transition. We also provide a manufacturing roadmap that can improve manufacturing efficiencies along the developmental journey.