Building a robust in-process testing plan for cell therapy manufacturing success
Abstract: Cell therapy manufacturing demands rigorous quality control, as living cell products cannot be terminally sterilized and are often produced in small batches. Developers must implement robust in-process testing strategies to ensure safety, efficacy, and consistency throughout production. This article outlines a six-stage testing plan—from defining critical process parameters and quality attributes, to real-time monitoring, method validation, data integrity, and continuous improvement. It emphasizes the value of partnering with a CDMO to access advanced analytical technologies, regulatory guidance, and customized solutions, enabling developers to overcome QC challenges and consistently deliver high-quality cell therapies.