Abstract
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.
Highlights
Regenerative medicine refers to the branch of medicine that attempts to replace or regenerate human cells, tissues or organs in order to restore or establish normal function [1]
Regenerative medicine has the potential to emerge as a major growth driver of the global economy, a potential that is demonstrated by the worldwide tissue engineering (TE) and cell therapy market [3]
Traditional engineering domains have for many years adopted quality by design (QbD), and in silico models are actively used as an integral part of the R&D pipeline and decision-making process, increasing innovation, productivity and robustness and reducing time to market
Summary
Regenerative medicine refers to the branch of medicine that attempts to replace or regenerate human cells, tissues or organs in order to restore or establish normal function [1]. Traditional engineering domains have for many years adopted QbD, and in silico models are actively used as an integral part of the R&D pipeline and decision-making process, increasing innovation, productivity and robustness and reducing time to market Translating this to the regenerative medicine field, the use of simulation tools could enable the incorporation of knowledge on mechanisms of action (i.e. underlying biological mechanisms) into the ATMP development pipeline, permitting the field to move away from the trial-and-error approach (blind screening) and increase its success rate for clinical transfer (see [6] for an example in the cancer field). 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
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