What are the quality challenges regarding comparibility considerations of Advanced Therapy Medicinal Products?

Véronique Andrieu (1) , Éloïse Gennet (2) , Julie Veran (3) , Michael Morrison (4) , Florence Sabatier (5) , Aurélie Mahalatchimy (2)

1 MEPHI - Microbes évolution phylogénie et infections
2 DICE / CERIC - Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)
3 APHM - Assistance Publique - Hôpitaux de Marseille
4 University of Oxford
5 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research

The question of comparability for Advanced Therapy Medicinal Products (ATMPs) is very often asked during Scientific Advice Meetings at the European Medicines Agency. Indeed, changes to ATMPs manufacturing processes, improvements/changes in equipment, raw materials and critical starting materials, or process scale are frequent in the early stages of development or even after marketing authorization. Quality comparability is the first step in the review of variations procedures of a medicinal product. Indeed, quality information is of major importance with analytical testing, risk-based approach and manufacturing evaluation as it will allow to conclude if non clinical and clinical data on comparability are also needed or not. The text of December 2019 of the Committee for Advanced Therapies (CAT), entitled “Questions and answers, Comparability considerations for Advanced Therapy Medicinal Products” contains the major questions companies can have when a comparison is needed between the pre- and post-change of the manufacturing process of ATMPs. The answers are based on analytical and statistical tools which are needed in frequent experimental changes situations. Generally, this text addresses the issues linked to the demonstration of comparability regarding the quality aspects of ATMPs. Another important text is the ICH Q5E guideline that addresses comparability of biological/biotechnological medicinal products which legally cover ATMPs. However, ATMPs are outside the scope of this guideline, except for the general principles that can be applied to ATMPs. Through of comparative textual analysis of these two texts, this poster will show the complementarity of the information provided, but also the very dynamic impact of the Q&A text targeted on ATMPs in comparison with the large recommendations of the ICH guideline on biotech products.

Domaines: Droit

Véronique Andrieu, Éloïse Gennet, Julie Veran, Michael Morrison, Florence Sabatier, et al.. What are the quality challenges regarding comparibility considerations of Advanced Therapy Medicinal Products?. Annual Conference of the European Association of Health Law, Apr 2022, Ghent, Belgium. ⟨halshs-03780293⟩