A Framework for Automated Quality Assurance and Documentation for Pharma 4.0.

The production sector is experiencing significant transformations driven by comprehensive digitalization, interconnection, and further automation advances. One sub-sector that can benefit significantly from these trends is the production of Advanced Therapy Medicinal Products (ATMPs). ATMPs show promise for treating different serious conditions, but they are very expensive—being patient tailored products whose production is a highly manual, minimally automated process. In a recent research project with an ATMP producer, we investigated how the degree of automation can be increased. It became apparent that in parallel to increasing automation across the actual production steps, quality assurance needs to be addressed in a similar way. This paper introduces a framework for automating (parts of) the quality assurance of ATMPs using two concepts: (a) digital shadows or twins and (b) assurance cases. We demonstrate its conceptual implementation along a case study for Car-T cell products used to treat certain forms of cancer.