Department of Chemical Engineering, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Simulation Laboratory, Department of Chemical Engineering, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Adv Exp Med Biol. 2018;1078:445-463. doi: 10.1007/978-981-13-0950-2_23.
Tissue engineering and the manufacturing of regenerative medicine products demand strict control over the production process and product quality monitoring. In this chapter, the application of process systems engineering (PSE) approaches in the production of cell-based products has been discussed. Mechanistic, empirical, continuum and discrete models are compared and their use in describing cellular phenomena is reviewed. In addition, model-based optimization strategies employed in the field of tissue engineering and regenerative medicine are discussed. An introduction to process control theory is given and the main applications of classical and advanced methods in cellular production processes are described. Finally, new nondestructive and noninvasive monitoring techniques have been reviewed, focusing on large-scale manufacturing systems for cell-based constructs and therapeutic products. The application of the PSE methodologies presented here offers a promising alternative to overcome the main challenges in manufacturing engineered tissue and regeneration products.
组织工程和再生医学产品的制造需要严格控制生产过程和产品质量监测。本章讨论了过程系统工程（PSE）方法在基于细胞产品生产中的应用。比较了机理、经验、连续和离散模型，并回顾了它们在描述细胞现象中的应用。此外，还讨论了组织工程和再生医学领域中使用的基于模型的优化策略。介绍了过程控制理论，并描述了经典和先进方法在细胞生产过程中的主要应用。最后，综述了新的无损和非侵入性监测技术，重点介绍了基于细胞构建体和治疗产品的大规模制造系统。这里介绍的 PSE 方法的应用为克服工程组织和再生产品制造中的主要挑战提供了一种很有前途的替代方法。
