Optimizing the Pre-Filled Syringe Filling Process for Biological Molecules

This poster was produced while attending the PhD programme in Medical Biotechnologies at the University of Chieti, Cycle XXXIX, with the support of a scholarship co-financed by the Ministerial Decree no. 117 of 2nd March 2023, based on the NRRP - funded by the European Union - NextGenerationEU - Mission 4 "Education and Research", Component 2 "From Research to Business", Investment 3.3, and by the company Aenova Group Latina site. In recent years, the demand for user friendly injectable delivery systems has incresed, highlighting the importance of Pre filled Syringes (PFS) as a significant innovation in drug delivery. Among current Fill/Finish technologies, peristaltic pump dosing and single use filling assemblies have gained attention for their gentle handling of formulations and minimized shear stress. This study evaluated a custom designed, single use filling assembly made of ePTFE and silicon, chosen to reduce operator handling in aseptic conditions. The assembly is high temperature resistant, supports cleaning and sterilization in place (CIP/SIP), and withstands mechanical stress with minimal spallation, making it highly practical for PFS manufacturing. The study focused on the impact of filling line parameters and assembly geometry on the filling profile and dosing accuracy. Using a Design of Experiments and capability analysis, an optimal combination of filling profile and sustainable filling speed was identified. The findings by Aenova’s Latina site establish a benchmark for Fill/Finish processes, demonstrating that the selected materials and configuration are a viable option for manufacturing biologics sensitive to gamma radiation or high hydrogen peroxide exposure. This ensures filling stability over extended production runs, offering valuable guidance for the industry in producing high-quality, reliable PFS.