Stem Sel srl, Bologna, Italy.
Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.
J Pharm Biomed Anal. 2024 Aug 15;246:116182. doi: 10.1016/j.jpba.2024.116182. Epub 2024 Apr 29.
Advanced therapy medicinal products (ATMP) are complex medicines based on gene therapy, somatic cell therapy, and tissue engineering. These products are rapidly arising as novel and promising therapies for a wide range of different clinical applications. The process for the development of well-established ATMPs is challenging. Many issues must be considered from raw material, manufacturing, safety, and pricing to assure the quality of ATMPs and their implementation as innovative therapeutic tools. Among ATMPs, cell-based ATMPs are drugs altogether. As for standard drugs, technologies for quality control, and non-invasive isolation and production of cell-based ATMPs are then needed to ensure their rapidly expanding applications and ameliorate safety and standardization of cell production. In this review, emerging approaches and technologies for quality control of innovative cell-based ATMPs are described. Among new techniques, microfluid-based systems show advantages related to their miniaturization, easy implementation in analytical process and automation which allow for the standardization of the final product.
先进治疗药物产品（ATMP）是基于基因治疗、体细胞治疗和组织工程的复杂药物。这些产品作为新型有前途的疗法，正在迅速涌现，适用于广泛的不同临床应用。成熟 ATMP 的开发过程极具挑战性。必须从原材料、制造、安全性和定价等多方面考虑，以确保 ATMP 的质量及其作为创新治疗工具的实施。在 ATMP 中，基于细胞的 ATMP 是一种药物。与标准药物一样，需要用于质量控制的技术以及非侵入性分离和基于细胞的 ATMP 的生产，以确保其快速扩展的应用，并改善细胞生产的安全性和标准化。本文综述了用于控制新型基于细胞的 ATMP 的质量的新兴方法和技术。在新技术中，基于微流控的系统因其小型化、易于在分析过程中实施和自动化而具有优势，这允许对最终产品进行标准化。
