Spotlight: Industry 4.0 for cell and gene therapy- a distant dream or reality?

Cell therapies through their curative potential offer life-changing treatment options to patients with no other recourse. In a few short years, they have achieved unprecedented success as evidenced by the growing numbers of commercial approvals and clinical trials across the globe. Despite this success, cell therapy developers continue to face many challenges including manufacturing complexities, costs, scalability, and regulatory compliance. One strategy to overcome these barriers and democratize cell therapies is the adoption of Industry 4.0 principles that utilize data-driven manufacturing with advanced analytics. Data-driven manufacturing enables developers to acquire and analyze data related to cell health, cell behavior, and build predictive models for process optimization. Advanced analytics is the backbone of process optimization and quality control, as it allows for observation of trends, mitigation of problems in real-time and enables informed decisions for successful manufacturing. The manufacturing space can benefit from advanced analytics tools such as predictive modeling, data management and mining, AI, and machine learning to better understand critical quality attributes and critical-process parameters and help build efficient workflows, thus making these life-changing therapies more accessible.