Integrated product and manufacturing system platforms supporting the design of personalized medicines

Abstract

Pharmaceutical product customization, a prerequisite for personalized medicines, is currently a widely researched topic. Patient characteristics can be mapped and translated into parameters for designing patients’ individual treatment, i.e., the dosage form. However, current pharmaceutical manufacturing is dominated by mass production and lacks the capability and flexibility required to produce customized products. Mass customization is a proven successful approach in, for example, the manufacturing industry and thus has been discussed as an enabler for pharmaceutical product customization but has never been fully explored in a pharmaceutical context. Inspired by mass customization approaches in the manufacturing industry, this study proposes a novel methodology to develop integrated product and manufacturing system platforms for pharmaceutical products supporting a mass customization paradigm. The proposed methodology establishes sets of product and manufacturing system platform variants and suggests an approach to feasible platform design selection. The applicability of the proposed methodology is illustrated for diabetes treatment as a selected case example. Integrated platform designs are developed for the conventional treatment of a fully integral tablet design and for a design enabling product customization with a modularized tablet design. The manufacturing platforms are still embracing a mass production design in the methodology illustration and should elicit knowledge on the utility of the current production design in a mass customization context. The performance and utility of the respective platform are assessed in terms of production cost and patient benefit. The results suggest a substantial increase in patient benefit afforded by the modularized tablet design, however the production cost is increased. This trade-off between the production cost and patient benefit thus calls for novel manufacturing system concepts to achieve the feasible manufacturing of customized pharmaceutical products.