Abstract
The latest scientific advances in the field of cell and molecular biology allowed the development of a new category of therapies, based on the cells (gene therapy, cell therapy, and tissue engineering), collectively known as Advanced Therapies Medicinal Products (ATMPs). ATMPs can be defined as products which consists of cells that have been subject to substantial manipulation or that are not intended to be used for the same essential function(s) in the recipient and the donor. ATMPs are characterized by complex manufacturing bioprocesses, under Good Manufacturing Process (GMP) rules, and offer new therapeutic opportunities for different diseases, including those of genetic origin, tumors, and neurological diseases, that currently have limited or no effective conventional therapeutic options. To date, Cell Therapy Medicinal Products are the most developed and used as drugs for the cure of different pathologies, so we will focus our discussion on the description of this type of medicinal products.
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Lisini, D., Frigerio, S., Nava, S., Pogliani, S. (2022). Stem Cell Production: Processes, Practices, and Regulation. In: Khan, F.A. (eds) Stem Cell Production. Springer, Singapore. https://doi.org/10.1007/978-981-16-7589-8_6
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