In recent years, the market demand for user-friendly injectable delivery systems has increased.

The development of Prefilled Syringes (PFS) has piqued substantial interest in the industry, primarily due to its unique advantages. PFS, designed for self-administration, offers rapid injection efficiency and unparalleled dosing accuracy, making it a game changer in the field of injectable delivery systems.

Among the currently available fill-and-finish technologies, peristaltic pump dosing and single-use filling assemblies have attracted attention as clean technologies that allow gentle product transfer and minimize shear stress on formulation.

For this study, conducted at the Aenova Group’s Latina site in collaboration with the Pharmacy Department of “G. D’Annunzio” University (Chieti-Pescara), a custom-designed, single-use filling assembly made of ePTFE and silicon was utilized. This innovative assembly, chosen to minimize operator handling and connection in an aseptic environment, is high-temperature resistant, can be cleaned in place (CIP) and sterilized in place (SIP) and is resistant to mechanical stress with minimal spallation phenomenon. These features significantly contribute to its practicality and effectiveness in PFS manufacturing.

The quality of the filling profile is critical to ensure dosing accuracy. Therefore, the study’s scope was to understand the influence of the filling line parameters and the geometry of the filling assembly on the filling profile and dosing accuracy.

A design of experiments approach was applied, and a capability analysis was performed to evaluate statistical process control. An optimal combination of the best possible filling profile and filling speed sustainable for business purposes was identified, providing valuable insight into the challenges of PFS manufacturing.

The results obtained by Aenova, set a benchmark for fill-and-finish manufacturing processes. They show that the configuration and type of materials identified can be a viable alternative for the production of biological injectables whose active ingredients are susceptible to gamma radiated materials or exposure to high levels of hydrogen peroxides. This finding ensures filling stability for extended production runs, providing crucial information for the industry.

Aenova is a global leading Contract Development and Manufacturing Organization with a Competence Center for sterile technologies at its site in Latina, Italy.

The study on the topic "Optimizing the Prefilled Syringe Filling Process for Biological Molecules Using Innovative Single-Use Technologies: A Design of Experiments Approach" is published in the current issue of the renowned magazine “Pharmaceutical Manufacturing and Packaging Sourcer – Parenteral Technology Supplement 2024”.

With credits to: Pharmaceutical Manufacturing and Packing Sourcer, Parenteral Technology Supplement 2024, pages 37-41. © Samedan Ltd.

Aenova Fill and Finish study on optimized filling process Parenteral Tech Supp 2024