Integrated Product and Production Platforms for Pharmaceutical Products: Design Thinking for the Development of Personalized Medicines

Sammanfattning: Treatments, when customized according to individual patient attributes, are in recent years referred to as personalized medicines. Personalized medicines aim at improving the therapeutic outcome of the patient. However, current pharmaceutical production is dominated by mass production in a batch manner, i.e. producing large volumes of identical products. Uncertainties prevail regarding the ability of current production to respond to the product customization need in an economically and technically realizable manner. However, without customized treatment reaching the patient the benefit of personalized medicines cannot be achieved. Hence, a mass customization-paradigm, i.e. economic feasibility when designing, producing and delivering customized pharmaceutical products, is desired. Pharmaceutical product customization has been discussed from a product and production perspective. These discussions mainly focus either on product or production design. Additionally, the economic feasibility of suggested approaches is not fully explored. Mass customization requires joint consideration of product and production system design. Hence, the aim of this thesis is to explore integrated pharmaceutical product and production system design facilitating a shift toward mass customization-paradigm. Methodologies to design the integrated product and production systems of pharmaceutical products supporting customization are proposed. Set-based concurrent engineering (SBCE) principles are adapted due to the ability of efficient product development. Platform-based design is adapted due to a successful approach to mass customization in manufacturing industry. Additionally, an integrated design approach to product value assessment is proposed to emphasize the customized pharmaceutical product value. The methodology application is illustrated for oral dosage forms for the purpose of demonstrating refined approaches to integrated design of these. Knowledge regarding oral dosage forms as enablers for personalized medicines is generated. Results show that the adaption of SBCE principles enables efficient consequence analysis of pharmaceutical product designs for production system designs and is accomplished by acquiring a set-based approach to simultaneous assessment of the performance of various designs. Platform-based design enables flexible pharmaceutical product and production system design, thus supporting mass customization. Finally, oral dosage forms embracing modularized designs provide substantial product design flexibility but affects manufacturing complexity and hence, the discussion of product and production system design cannot be separated.