Montemurro Tiziana, Viganò Mariele, Budelli Silvia, Montelatici Elisa, Lavazza Cristiana, Marino Luigi, Parazzi Valentina, Lazzari Lorenza, Giordano Rosaria
Cell Factory, Unit of Cell Therapy and Cryobiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
Drug Des Devel Ther. 2015 Aug 20;9:4825-34. doi: 10.2147/DDDT.S80403. eCollection 2015.
In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.
在21世纪的背景下，需要新的治疗工具来应对日益频繁的退行性疾病和人口老龄化带来的社会和医学挑战。最近创建的先进治疗药物产品类别包括细胞、基因治疗和组织工程产品，作为一类新型药物。它们的生产需要与传统药物相同的制药框架，这意味着工业规模的制造过程必须适应含细胞产品的特殊特性。我们医院在21世纪初迎接了这条新道路的挑战；在此，我们描述了在公立医院环境中建立药品级设施所采取的方法，旨在分享我们为使细胞治疗符合高标准药品生产和质量控制要求而找到的解决方案。
