Abstract
In recent years advances in biology, biotechnology, and medical research have led to a new category of biologicals – the advanced therapy medicinal products (ATMPs). ATMPs open up new possibilities to treat diseases that have so far challenged medicine. Although the category of ATMPs includes various classes such as gene therapy medicinal products, somatic cell therapy products, and tissue-engineered products, their overarching definition includes their potential to pharmacologically, immunologically, or metabolically restore, correct, or modify the patient’s physiological function. As for all biologicals the market authorization of ATMPs is regulated in a complex framework by the respective authorities. The investigation of the distribution of these cells within the recipient body is crucial for the assessment of ATMPs, specifically to see if the ATMP arrives exclusively at the intended location or can be found also at unintended sites. Identifying a specific antigen or gene sequence, which is only occurring in the ATMP, helps to discriminate between ATMP cells and the cells of the receiving host. Immunohistochemistry, in situ hybridization, or polymerase chain reaction can be applied consequentially with different advantages and disadvantages. ATMPs are of increasing interest because of their properties to treat a disease in its fundamental dysregulation of the immune system. There is a risk that the immune balance is not achieved and that overshooting or immunosuppressive mechanisms lead to unwanted side effects. A detailed consideration of the possible side effects based on the molecular mechanisms and an appropriate testing strategy should help to make these therapies safe.
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Neuhaus, V., Schaudien, D., Dehmel, S. (2023). Advanced Therapy Medicinal Products. In: Hock, F.J., Gralinski, M.R., Pugsley, M.K. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Cham. https://doi.org/10.1007/978-3-030-73317-9_143-1
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