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.

中文翻译：

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支持个性化药物设计的集成产品和制造系统平台

摘要 医药产品定制是个性化药品的先决条件，目前是一个广泛研究的课题。患者特征可以被映射并转化为用于设计患者个体治疗的参数，即剂型。然而，目前的医药制造以批量生产为主，缺乏生产定制产品所需的能力和灵活性。大规模定制是一种经过验证的成功方法，例如在制造业中，因此被讨论为药品定制的推动因素，但从未在制药领域得到充分探索。受到制造业大规模定制方法的启发，这项研究提出了一种新的方法来为支持大规模定制范式的医药产品开发集成产品和制造系统平台。所提出的方法建立了产品和制造系统平台变体的集合，并提出了一种可行的平台设计选择方法。作为选定的案例示例，说明了所提出的方法对糖尿病治疗的适用性。集成平台设计是为完全集成的平板电脑设计的常规处理以及通过模块化平板电脑设计实现产品定制的设计而开发的。制造平台仍在方法论说明中采用大规模生产设计，并且应该了解当前生产设计在大规模定制环境中的效用。各个平台的性能和效用根据生产成本和患者利益进行评估。结果表明，模块化片剂设计可显着提高患者的利益，但增加了生产成本。因此，生产成本和患者利益之间的这种权衡需要新的制造系统概念来实现定制药品的可行制造。