Wednesday, 27 July 2022 12:20

ECVAM: Study on animal-free methods in immunogenicity testing of advanced therapy medical devices Featured

Medical devices for advanced therapies are gene therapies, somatic cell therapies, or the use of genetically modified tissues in cases where conventional therapies fail. Such medical devices must also be tested for safety and possible immune reactions in the same way as drugs or other medical devices.

Due to the fact that the immune systems of humans and animals are very different, animal models are very questionable and animal experiments often lead to the fact that preclinical results from animal experiments can only be inadequately transferred to the subsequent clinical phases or medical products have to be withdrawn from the market due to immune reactions in the patient.

Therefore, new animal-free methods are the order of the day. The European validation authority EURL ECVAM has therefore conducted a study to review the state of the art in new animal-free models. The authors selected 88 peer-reviewed articles from the literature in which new non-animal methods had been used to test for immunogenicity. These were mainly in vitro methods using cells and tissues and - very underrepresented - in silico methods.

The authors see room for improvement in the new methods. For one thing, they recommend a more reliable and scalable supply of donor immune cells, as well as the use of omics technologies and the consideration of high-throughput and high-content analyses to draw more information from the experiments. They also recommended greater consideration of in silico methods.

Of notable note, ECVAM has developed a knowledge base from their study that should be of particular interest to developers of medical devices for advanced therapies, as well as in the field of education, training, and continuing education. Other interested parties are also likely to look inside, as the database is free and generally accessible.

Original publication:
Canals, J., Romania, P., Belio-Mairal, P., Nic, M., Dibusz, K., Novotny, T., Busquet, F., Rossi, F., Straccia, M., Daskalopoulos, E., Dura, A., Gribaldo, & Whelan, M. (2022). Advanced non-animal models in biomedical research. EUR 30334/4 EN, Publications Office of the European Union, Luxembourg. ISBN 978-92-76-49092-0, doi:10.2760/153339, JRC126997.


Knowledge base: