Bridging process diversity in cell therapies toward standardization of manufacturing workflows

Cell therapies offer transformative potential for a wide range of diseases. However, their manufacturing remains complex due to the inherent variability of living cells, sensitivity to culture conditions and diverse differentiation and genetic engineering requirements. Autologous and allogeneic modalities, along with the intended clinical application, impose distinct demands on production scale, workflow flexibility and quality control, while donor variability and available starting material further challenge process reproducibility. This review examines the unique requirements of multiple cell therapy modalities, including chimeric antigen receptor T cells, induced pluripotent stem cell-derived products, and mesenchymal stem/stromal cells, and compares their manufacturing processes to identify opportunities for standardization. We analyze both upstream and downstream processing steps, including cell isolation, expansion, purification, concentration, formulation and cryopreservation, highlighting technological solutions such as closed, automated platforms and integrated modular systems that enable flexible operation. The use of real-time monitoring via process analytical technology, combined with machine learning and artificial intelligence, is also discussed for identifying critical quality attributes and guiding process control. We discuss the relevance of harmonizing workflows across modalities to not only improve reproducibility, scalability and cost-effectiveness in cell therapy manufacturing, but also accelerate the development of new cell therapies by enabling broadly applicable process steps to be adapted across multiple cell therapy platforms.