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Advanced Non-animal Models in Biomedical Research

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Immunogenicity testing for advanced therapy medicinal products
Advanced therapy medicinal products (ATMPs) are innovative therapies expected to reshape our approach towards several pathologies, particularly those that do not respond adequately to conventional treatments. ATMPs are based on gene therapy, somatic-cell therapy, engineered tissues and combinations of those. Immunogenicity testing is an important step in the development of these therapies since it aims to predict an adverse immune response of a patient prior to receiving a particular treatment. Fundamental biological differences between the immune system of different species frequently limit the human applicability of immunogenicity testing results carried out using animal models. The JRC’s EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) therefore carried out a study to review the state-of-the-art of advanced non-animal models in use for immunogenicity testing in ATMPs. The majority of the 88 models that were identified were based on in vitro techniques with a limited amount of in silico methods, and most of these focused on the investigation of cell therapy products. This review highlights a pressing need for the development and acceptance of more sophisticated and innovative non-animal approaches in this field which will pave the way for the broader use of ATMPs in the clinic.
2022-07-21
Publications Office of the European Union
JRC126997
978-92-76-49091-3 (online),    978-92-76-49092-0 (print),   
1831-9424 (online),    1018-5593 (print),   
EUR 30334/4 EN,    OP KJ-NI-30334-EN-N (online),    OP KJ-NI-30334-EN-C (print),   
https://publications.jrc.ec.europa.eu/repository/handle/JRC126997,   
10.2760/7190 (online),    10.2760/153339 (print),   
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