CC BY-NC-ND 4.0Hort, SimonSimonHortSanges, CarmenCarmenSangesJacobs, John J.L.John J.L.JacobsHudecek, MichaelMichaelHudecekSchmitt, Robert H.Robert H.Schmitt2024-02-062024-02-062023-10-26https://publica.fraunhofer.de/handle/publica/459703https://doi.org/10.24406/publica-258610.24406/publica-258610.1016/j.procir.2023.09.121With the approval of CAR-T cell therapy as a treatment for acute leukemia and lymphoma in 2018, the first advanced therapy medicinal product (ATMP) came onto the market. ATMPs are cell- and gene-based products and very promising therapies for the successful treatment of various hereditary diseases and cancers. In recent years, more ATMPs have been approved and a strong increase is expected considering current clinical trial numbers. However, CAR-T cell production still poses great challenges. The CAR-T treatment is very costly for approved products (approx. 400.000 $). Most of the associated costs are due to the expensive manufacturing processes. Furthermore, autologous CAR-T cell therapy is limited in its scalability by a patient-specific make-to-order approach which makes economic production difficult. To make CAR-T cell products and other ATMP available to a large number of patients, the complex multi-step manufacturing process must be further developed and the potential for automation and digitalization exploited. Therefore, this article provides an analysis of CAR-T cell production focusing on characteristics, challenges, and optimization potential. For strategic guidance in the digital transformation, a systematic approach, based on the Industry 4.0 maturity index, is introduced categorizing challenges and use cases into six stages.enCAR-TATMPImmunologyIndustry 4.0Pharma 4.0Advanced therapiesDDC::600 Technik, Medizin, angewandte Wissenschaften::620 IngenieurwissenschaftenDDC::600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheitjournal article