Can Advanced Analytics with Data-Driven Manufacturing Power Up Cell Therapy
Abstract: Cell therapies have complex manufacturing needs since the final drug product is viable cells comprising thousands of proteins, lipids and carbohydrates that can change with every manipulation step. Monitoring critical process parameters (CPPs) during manufacturing helps prevent drifts and deviations that can compromise product safety and quality. Data-driven manufacturing with integrated analytics enables developers to acquire and analyze data and make pro-active process improvements to achieve efficiency and reproducibility. Furthermore, AI-driven and machine learning-powered analytics offer flexible in-process controls, enhancing each phase of manufacturing. Early adoption of batch evolution model (BEM) commonly used in other modalities, can optimize cell therapy manufacturing by establishing standardized, data-driven, and controlled processes that can enhance both product efficacy and patient safety. Right First Time (RFT) manufacturing is fundamental for all cell therapies, and particularly vital for time-sensitive autologous therapies. Implementing a data-driven manufacturing strategy is essential to achieving success, lowering costs, and enhancing the commercial viability of these transformative treatments.