eTheRNA, has built an impressive know-how and expertise in the production of mRNA constructs for research purposes.
From a strategic point of view, eTheRNA wishes to capitalize on the mRNA-production experience it has built over the years. This strategic decision is further amplified by eTheRNA's strategy to develop a naked mRNA product that can be directly injected (in vivo), in addition to the existing cellular mRNA product (that is based on autologous dendritic cells that are extracted from the human body to be loaded ex vivo with tumor-associated antigens before being reinjected).
In October 2018, eTheRNA has inaugurated, adjacent to its headquarters in Niel, a EUR 5 million facility, designed to Current Good Manufacturing Practices (cGMP) specifications and certified by the Belgian Federal Agency for Medicines and Healthcare Products. This mRNA facility gives eTheRNA the capacity to manufacture mRNA-based TriMix immunotherapies for Phase 1 and 2 clinical development programs as well as for preclinical studies. Initially, eTheRNA intends to use the facility exclusively to supply material for its own existing and planned clinical studies. Depending on future demand, the Company has the option to expand capacity. This facility is an opportunity to develop new global R&D collaborations based on our manufacturing capabilities.”