Aims
The field of cell-based therapies for human diseases is currently
evolving from promising treatment options to established therapeutic
concepts. The design of the non-clinical development program for
cell-based products, intended to provide a rationale for treatment and
to gain insight into the safety profile, is challenging because of
limitations caused by species-specificity. The elements of the
non-clinical package for cell-based products were evaluated using advice
reports from the European Medicines Agency database from 2013-2018 to
identify the approach followed for non-clinical development of these
products.