Delivering patients with safe and effective therapies requires robust and scalable manufacturing processes. In cell therapies (CT), ensuring consistent and scalable cell expansion can prevent deviations in product quality and thus improve treatment outcomes in patients. In gene therapies (GT), scalable processes are imperative for improving and sustaining high viral vector productivity.

Growing demand for CT and GT necessitates the development of more efficient, robust and larger yield processes. This calls for real-time monitoring and frequent at-line information of process parameters that impact cell growth and health. In addition, controlling nutrient (e.g. glucose and amino acid) levels to avoid the accumulation of toxic metabolites (e.g. lactate), is key. Monitoring sufficient depth and breadth of process parameters provides invaluable insights into the metabolic state of cell cultures, enabling control to optimize, and enhance manufacturing robustness. Many current process parameter measurements are informative, but labor-intensive, and some are too slow to be actionable in processes. Technologies for real-time and at-line bioprocess characterization have rapidly advanced in recent years to be easily deployable in different types of cell culture conditions and bioreactors.

We show solutions for both CT and GT:

• Process analytical technologies, at-line and real-time monitoring and control, pioneering strategies designed to address the challenges associated with CT and GT manufacturing.
• Process monitoring and control to increase process knowledge and enable data-driven process development and optimization for improved therapy outcomes.