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

Siiskonen, Maria Daniela Irene; Malmqvist, Johan; Folestad, Staffan

doi:10.1016/j.jmsy.2020.06.016

Cited by 30 publications

(38 citation statements)

References 25 publications

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“…Beyond product performance, unified integration with process and production will be required to promote access to affordable individualized therapy. Whilst initial explorations of product designs for individualization in a mass customization context have been performed [ 3 , 94 ], to this end, further aspects of the unified approach, beyond product modularization, remain to be explored (e.g., postponement and process flexibility) as enablers of a pharmaceutical mass customization paradigm. Even adaption of modular pharmaceutical product concepts into a pharmaceutical mass customization context still requires additional study areas, for example, establishment of appropriate affordability metrics, subsequent assessments of affordability, and the role of the position and type of module and product assembly steps in the pharmaceutical value chain, prior to their realization.…”

Section: Discussionmentioning

confidence: 99%

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

et al. 2020

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Independent individualization of multiple product attributes, such as dose and drug release, is a crucial overarching requirement of pharmaceutical products for individualized therapy as is the unified integration of individualized product design with the processes and production that drive patient access to such therapy. Individualization intrinsically demands a marked increase in the number of product variants to suit smaller, more stratified patient populations. One established design strategy to provide enhanced product variety is product modularization. Despite existing customized and/or modular product design concepts, multifunctional individualization in an integrated manner is still strikingly absent in pharma. Consequently, this study aims to demonstrate multifunctional individualization through a modular product design capable of providing an increased variety of release profiles independent of dose and dosage form size. To further exhibit that increased product variety is attainable even with a low degree of product modularity, the modular design was based upon a fixed target dosage form size of approximately 200 mm3 comprising two modules, approximately 100 mm3 each. Each module contained a melt-extruded and molded formulation of 40% w/w metoprolol succinate in a PEG1500 and Kollidon® VA64 erodible hydrophilic matrix surrounded by polylactic acid and/or polyvinyl acetate as additional release rate-controlling polymers. Drug release testing confirmed the generation of predictable, combined drug release kinetics for dosage forms, independent of dose, based on a product’s constituent modules and enhanced product variety through a minimum of six dosage form release profiles from only three module variants. Based on these initial results, the potential of the reconfigurable modular product design concept is discussed for unified integration into a pharmaceutical mass customization/mass personalization context.

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Section: Discussionmentioning

confidence: 99%

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

et al. 2020

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“…Three mass customization strategies (as outlined by, for example, Hu [7]) incorporate modular product architectures, reconfigurable manufacturing systems, and postponement. Siiskonen et al [20] studied manufacturing system design in a customization context and suggested that the current mass production platforms are not suitable to be operated in a mass customization context. Siiskonen et al [21] suggested reconfigured supply chain designs postponing the final assembly position of the treatments closer to the customer for the cost-efficient provision of customized pharmaceutical products.…”

Section: Mass Customizationmentioning

confidence: 99%

“…Siiskonen et al [21] suggested reconfigured supply chain designs postponing the final assembly position of the treatments closer to the customer for the cost-efficient provision of customized pharmaceutical products. Manufacturing system design and postponement for mass customization in a pharmaceutical context are outside the scope of this paper, but the reader is referred to the publications by Siiskonen et al [20] and Siiskonen et al [21] for further discussion on these topics.…”

Section: Mass Customizationmentioning

confidence: 99%

“…This study solely considers product design and the mass customization strategy of product modularization. For a comprehensive description of an approach to manufacturing modular product designs, the reader is referred to [20] and for discussion on applying the principle of postponement in a pharmaceutical context, the reader is referred to [21].…”

Section: Research Gapmentioning

confidence: 99%

“…Siiskonen et al [20] proposed an approach to assess the benefit of a treatment portfolio concerning dose scalability by suggesting the concept of quality decay. This concept describes the distance between the dose received by the patient, decided through the patient segmentation process, and the patient's optimal dose.…”

Section: B Dose -Dose Strength Scalabilitymentioning

confidence: 99%

See 2 more Smart Citations

Pharmaceutical Product Modularization as a Mass Customization Strategy to Increase Patient Benefit Cost-Efficiently

Siiskonen

Malmqvist

Folestad

2021

Systems

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Customized pharmaceutical products aim to comply with the individual needs of a patient to enhance the treatment outcome. The current pharmaceutical production paradigm is, however, dominated by mass production, where the pharmaceutical products embrace a one-size-fits-all design with a low possibility of treatment optimization to patient needs. This production paradigm is not designed or intended for customized pharmaceutical products and operating this production context for customized pharmaceutical products is argued to be cost-inefficient. To address this challenge of inefficient production of customized pharmaceutical products, this study proposes an approach to modular pharmaceutical product design. As a mass customization strategy, product modularization enables serving customers with customized products cost-efficiently. The proposed modular pharmaceutical products integrate three product design requirements originating from patient needs: a scalable dose strength, a flexible target release profile, and a scalable treatment size. An approach to assess the value of these product designs is presented, by means of proposing three benefit metrics complying with respective design requirements and a cost metric assessing the cost of producing these modular pharmaceutical product designs. Results suggest that pharmaceutical product modularization can, by keeping the number of produced components low, substantially increase the external product variety and, hence, enhance the treatment outcome of patients. Furthermore, results indicate that the achieved benefit for the patient through product modularization increases beyond additional costs arising during production. However, a careful modularization must be performed to optimize the tradeoff between the increased benefit and cost.

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Quality by Design (QbD) Approach for Individualized Products Based on Additive Manufacturing

Rantanen

2023

AAPS Introductions in the Pharmaceutical Sciences

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

Cited by 30 publications

References 25 publications

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

Pharmaceutical Product Modularization as a Mass Customization Strategy to Increase Patient Benefit Cost-Efficiently

Quality by Design (QbD) Approach for Individualized Products Based on Additive Manufacturing

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