RNA - Genetherapys
RNA Production Platform

Current RNA production and purification processes, as well as the development of standardized industrial protocols, have not followed the same explosive success of mRNA and ncRNA applications. Italy currently lacks a National Platform for high-quality RNA production, and the implementation of the RNA Production Platform within the National Center represents the essential support needed for industrializing the R&D advancements of disease-oriented Vertical Spokes. The facilities will also support the needs of Horizontal, technology-oriented Spokes, as a place to conduct research on RNA synthesis, formulation, and delivery and to move toward pre-clinical in vitro and in vivo testing of formulated RNA products.

For the production of materials used in clinical studies, the RNA Production Platform will be equipped with a quality system that aligns with regulatory agencies such as the Italian Medicines Agency (AIFA) and the European Medicines Agency (EMA). A Qualified Person (QP), as required by current Good Manufacturing Practice Regulations (cGMP), will be onsite to authorize the release of materials for clinical use.
Committed to embracing the geographical criteria outlined in Italy’s National Recovery and Resilience Plan (NRRP), the National Center will implement a dedicated space in Naples as a means to support activities in the South of Italy. This space will also occupy facilities that include a Proof of Concept (PoC) RNA Production Platform for pilot-scale RNA manufacturing and formulation in supporting pre-clinical in vitro and in vivo testing.