Production of ATMPs: What are the specificities for quality aspects ?

International audienceAdvanced Therapy Medicinal Products (ATMPs) is a European classification of medicinal products based on genes, cells and tissues that have been specifically regulated in the European Union (EU) from 2007. Their manufacturing (i.e. their production) raises specific challenges for ensuring quality and complying with regulatory requirements in order to obtain manufacturing and marketing authorizations. For this reason, detailed guidelines on Good Manufacturing Practices specific to ATMPs have been adopted by the European Commission, and have been enforceable since 2017. They are distinct from other guidelines on GMP applicable to other kinds of biological medicinal products. Separate GMP guidelines, covering manufacture of biological active substances and medicinal products for human use including biological active substances were revised in June 2018 with the objective of preventing overlaps in scope with the ATMP GMP guidelines. Our hypothesis is that the biological nature that commonly characterizes ATMPs and biologicals may give rise to significant similarities in the manufacturing aspects as addressed by the respective guidelines. Through a comparative textual analysis of the GMP guidelines for biological medicinal products and ATMPs, this poster will highlight the key areas of similarities and differences. This analysis reveals why we have two different texts and whether they are based on substantial differences regarding production between ATMPs and other types of biological medicinal products