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In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market

机译：在计算机再生医学中：计算工具如何在瞬息万变的市场中应对监管和财务挑战

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The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design.
机译：由于使用破坏性技术，当前的经济状况以及市场规模很小，细胞疗法市场是一个高度波动的市场。在这样的市场中，公司和学术研究机构都需要工具来增进了解，同时降低研发成本，提高产品质量和生产率并缩短产品上市时间。另一个困难是必须遵循的监管途径，这对于基于细胞的治疗产品而言是具有挑战性的，应依赖于设计质量（QbD）原则的实施。计算机模拟是一种工具，可以在再生医学领域解决上述挑战。这篇评论讨论了这种计算机模型，并更着重于生物过程。讨论了与此主题相关的三个示例。第一个示例来自制药工程领域，在该领域中，QbD原理及其通过使用计算机模型进行实施既是监管又是经济上的必要。第二个例子与红细胞的产生有关。所描述的计算机模型主要用于研究细胞治疗产品的生产过程，并特别注意该过程的经济可行性。最后，我们描述了一个模型的设置，该模型在骨骼组织工程的背景下捕获了组织工程组合产品开发中的基本事件。对于每个示例，给出了一些经济方面的简短介绍，然后介绍了一种或多种计算机工具，这些工具已被开发出来以允许实施QbD原理和优化设计。

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