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实现间充质基质细胞及其细胞外囊泡的临床应用——技术与经济评估

Enabling Mesenchymal Stromal Cells and Their Extracellular Vesicles Clinical Availability-A Technological and Economical Evaluation.

作者信息

Silva Ricardo M, Rosa Sara Sousa, Santos José A L, Azevedo Ana M, Fernandes-Platzgummer Ana

机构信息

Institute for Bioengineering and Biosciences, Department of Bioengineering Instituto Superior Técnico, Universidade de Lisboa Lisbon Portugal.

Associate Laboratory i4HB-Institute for Health and Bioeconomy Instituto Superior Técnico, Universidade de Lisboa Lisbon Portugal.

出版信息

J Extracell Biol. 2025 Mar 17;4(3):e70037. doi: 10.1002/jex2.70037. eCollection 2025 Mar.

Abstract

Mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs) have shown significant therapeutic potential across a wide range of clinical conditions, complementing the progress of MSC-based therapies, some of which have already received regulatory approval. However, the high cost of these therapies has limited their accessibility, creating an urgent need to explore manufacturing strategies that reduce the cost of goods and selling prices. This study presents the design and simulation of a scalable manufacturing platform for the co-production of clinical-grade MSC and MSC-EVs using SuperPro Designer. Various production scenarios were evaluated to maximise manufacturing capacity while analysing their impact on economic performance. Our findings demonstrate that for MSC-EVs doses containing 10 and 10 particles, selling prices range from 166 to 309€ and from 1659 to 3082€, respectively. For clinical doses of MSC, selling prices vary between 965 and 42,673€ depending on dose size and production scale. Importantly, the co-production approach enables cost-sharing between products, contributing to significantly lower prices compared to individual production. Overall, the proposed platform achieved an attractive payback time of 3 years and a return on investment of 36%. By increasing the number of staggered production units, further price reductions and improved economic metrics could be attained. In conclusion, this study highlights the potential of the proposed manufacturing platform to deliver cost-effective, clinical-grade MSC and MSC-EVs products, advancing the field of regenerative medicine and enhancing the accessibility of these innovative treatments.

摘要

间充质基质细胞衍生的细胞外囊泡(MSC-EVs)在广泛的临床病症中已显示出显著的治疗潜力,补充了基于间充质基质细胞疗法的进展,其中一些疗法已获得监管批准。然而,这些疗法的高成本限制了其可及性,迫切需要探索降低产品成本和销售价格的生产策略。本研究展示了使用SuperPro Designer对用于临床级MSC和MSC-EVs联合生产的可扩展制造平台的设计与模拟。评估了各种生产方案以最大化制造能力,同时分析其对经济绩效的影响。我们的研究结果表明,对于含有10⁶和10⁸颗粒的MSC-EVs剂量,销售价格分别为166至309欧元和1659至3082欧元。对于临床剂量的MSC,销售价格根据剂量大小和生产规模在965至42,673欧元之间变化。重要的是,联合生产方法能够在产品之间分担成本,与单独生产相比,有助于显著降低价格。总体而言,所提出的平台实现了3年的诱人回收期和36%的投资回报率。通过增加交错生产单元的数量,可以实现进一步的价格降低和经济指标改善。总之,本研究突出了所提出的制造平台在提供具有成本效益的临床级MSC和MSC-EVs产品方面的潜力,推动了再生医学领域的发展,并提高了这些创新疗法的可及性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c8e/11913891/e6e905314213/JEX2-4-e70037-g007.jpg

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