Production of ATMPs: What are the specificities for quality aspects? Aurélie Mahalatchimy1, Eloïse Gennet2, Michael Morrison3, Véronique Andrieu4, Julie Véran5, Florence Sabatier6 1 Permanent Researcher in law at the French National Centre for Scientific Research (CNRS, CR), Law Faculty, UMR 7318 DICE CERIC, CNRS, Aix Marseille University, Toulon University, Aix-en-Provence, France; 2 Post-doctoral Researcher in Law, Law Faculty, UMR 7318 International, Comparative and European laws (DICE) CERIC, CNRS, Aix- Marseille University, Toulon University, Aix-en-Provence, France; 3 Senior Research Fellow in Social Sciences, Centre for Health Law and Emerging Technologies (HeLEX), University of Oxford, United Kingdom; 4 Senior lecturer in Industrial Pharmacy and Pharmaceutical Regulation, Faculty of Pharmacy, Aix-Marseille University, Research Unit Microbes Evolution Phylogeny and Infection (MEPHI) Aix-Marseille University, IRD, France; 5 Responsible of Cell therapy/Advanced Therapy Medicinal Products’ production at Marseille Public Hospital (AP-HM), Biotherapies Clinical Investigation Center, France; 6 Professor of Hematology and Biotherapy, Pharmaceutical Sciences Faculty, C2VN INSERM INRAe 1263 AIX Marseille University, Director of the cell therapy research centre at Marseille Public Hospital (AP-HM), France. Acknowledgements: This work has been supported by ANR-funded I-BioLex project (ANR-20-CE26-0007-01, coord. A. Mahalatchimy). M. Morrison is funded by the Leverhulme Trust through grant no RPG-2017-330. INTRODUCTION Advanced 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. Hence, on top of its guideline on the manufacturing of Biological active substances and Medicinal Products for Human Use (26 June 2018, 25 pages revised to consider the new ATMP guidelines), the European Commission also issued Good Manufacturing Practice specific to Advanced Therapy Medicinal Products (22 November 2017, very detailed text of 90 pages). 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. DISCUSSION & CONCLUSION Explicitly stated that the text on biologicals does not apply to ATMPs which are covered by specific guidelines, but the two texts share common aspects related to the biological nature of the product: Relevance of having two distinct and exclusive texts? The two texts could benefit from being formulated in a more similar manner to facilitate full understanding and implementation by stakeholders, especially manufacturers. COMMON TOPICS Main similarities Manipulation of raw and starting materials of biological origin raising common risks and challenges of quality reproducibility and sustainability, traceability and risk of cross or exogenous contaminations (compatibility of containments, importance of process controls, strategy for initial and final certification and batch release) Similar spirit of the two texts § Crucial role of manufacturing and control processes in determining the quality § Biological origin and related inherent variability à requested standards of quality SPECIFICITIES OF BIOLOGICALS VERSUS ATMPs ATMPS BIOLOGICALS Specific risks as presented in the scopes and