Pre-filled syringes (PFSs) are extensively used as a container closure system offering convenience of administration . PFS features special and unique characteristics, enabling their proper functionality , but which, in some cases, may result in novel and unanticipated challenges. Such challenges are, for example, the potential interaction of the drug product with trace amounts of tungsten , originating from the pins used to form the syringe, or the presence of large concentrations of silicone oil droplets, potentially masking changes in proteinaceous particle load in a PFS product.
This chapter discusses some of the analytical approaches used to tackle such challenges in the development of PFS drug products.
Atanas Koulov, Ph.D
Senior Director, Analytical Development & QC