Traditional filling lines lack the necessary versatility to address the growing number of complex and personalized parenteral drug products that are now being brought to market. Evonik has recently qualified a new modular aseptic filling platform that will efficiently fill drug products in powder, liquid, suspension or combination form.
Many parenteral products that utilize advanced formulation technologies to deliver complex small molecules, peptides, proteins, and nucleic acids can face a number of stability, sterility, scalability and other cGMP manufacturing challenges. As one example, while terminal sterilization methods such as gamma irradiation are highly effective and reliable, this process may degrade the active pharmaceutical ingredient. This inherent incompatibility has necessitated the creation of specialized solutions for the aseptic manufacturing and filling of these parenteral drug products.