title: Aurigon's point of view on the safety assessment of cell-based therapies: an experience based on the participation in 15 ATMPs projects.
abstract: Cell-based medicinal products (CBMP) require the use of a case-by-case, risk-based, and scientifically justified nonclinical safety testing approach. The challenge is to translate regulatory requirements into concrete testing designs while overcoming technical limitations inherent to animal models and the CBMP and assaying combination strategies to reduce animal use and save time and budget.
authors.affiliation: Aurigon Life Science GmbH, Bahnhofstraße 9-15, 82327, Tutzing, Germany, emmanuelle.cornali@aurigon.de.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Cornali
mesh_terms: D000818:Animals; D002471:Cell Transformation, Neoplastic; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D023421:Models, Animal; D014116:Toxicology