Integrated Product and Process Design for Mass Customization: A Road Towards Patient Access to Individualized Pharmaceutical Therapy

Abstract: Individualized pharmaceutical therapy strives to attain optimal health outcomes a priori in all patients treated with pharmaceutical products by tailoring these products to each patient’s holistic needs. However, existing mass-produced pharmaceutical products are not available in sufficient variety to enable adequate tailoring to the diverse needs of individuals. Consequently, this thesis has, firstly, recognized a potential alternative production approach designed for the provision of affordable variety, namely, mass customization. Thereafter, key product and process design requirements for establishing mass customization opportunities in the pharmaceutical value chain were identified and demonstrated. The foundation and key contribution of this thesis is a proposed patient-centric framework of design requirements for individualization of each oral dosage form feature. Additionally, an overarching product requirement for multifunctional individualization was determined, i.e., the simultaneous, independent individualization of multiple product features, which had not been addressed prior to this thesis. With a primary focus on product modularization, this thesis demonstrates that multifunctional individualization and the enhanced product variety crucial for affordable individualization may be achieved through reconfigurable modularization. Hot melt extrusion and fused deposition modelling were collectively deemed high-potential technologies for the fabrication of individualized products. However, this thesis reveals key material and manufacturing trade-offs between material diversity, dispensing precision, and geometric design flexibility, arising due to strict product and process requirements, which remain unsolved. Throughout, a systems approach is demonstrated to tackle existing interdependencies and, in future, navigate change on the road towards realization of accessible individualized therapy.