Navigating The Complexities Of Pre-Filled Syringe Manufacturing

By Martin Gonzalez, Senior Manager, Product Development at Pfizer CentreOne

As demand for pre-filled syringes (PFS) continues to grow — driven by the rise of biologics, chronic disease therapies, and patient-centric delivery — drug developers face increasingly complex technical and operational challenges in bringing these products to market.

This whitepaper delves into the intricacies of PFS manufacturing, covering critical considerations such as managing sensitive formulations, minimizing high-value product loss, ensuring precision in fill-finish operations, and maintaining compliance with evolving regulatory standards. Drawing on Pfizer CentreOne’s extensive expertise in sterile injectables (SI), it highlights practical strategies and proven solutions designed to help navigate these challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.