To ensure functionality of pre-filled syringe systems, the pharmaceutical industry has been utilizing silicone to ensure system functionality and performance. However, silicone poses many challenges not only to the drug product, but also to the manufacturing process. This talk will focus on some of the latest insights to highlight the challenges that silicone can introduce to the newer, more complex and sensitive biologics like aggregation, precipitation or immunogenicity issues. Gore will then share how the removal of silicone can lead to more options for pharmaceutical manufacturers to have a robust product solution.