Developing a scalable, robust, and economically viable process that delivers high quality mRNA requires careful consideration of the manufacturing steps, including the definition of relevant in-process controls and critical quality attributes. It starts with the mRNA sequence of the template, which affects not only the development process but also the quality system, supply chain, equipment, raw materials, and consumables. In addition to the above, we will demonstrate why the downstream process should be adaptable and flexible, with the intrinsic physicochemical characteristics of a specific mRNA construct determining the selection of the most appropriate approach.
Ilaria Pettinati, PhD, Group Lead Process Development - mRNA
Telmo Graca Ph.D., Process and Technology Lead - mRNA