Principal Scientist Amgen Thousand Oaks, California
With increasing use of silicone oil lubricated prefilled syringes (PFS) as a primary container for biotherapeutics, silicone oil particles shed from PFS has become a topic of safety concern. This presentation will explore the immunogenicity impact of various types of silicone oil particles in protein drug product in in vitro and in vivo model systems and the implications for biopharmaceuticals.
Learning Objectives:
Understand if any potential concerns are posed by the presence of silicone oil particles in drug product.
Classify different types of silicone oil particles and associated concerns.
Appreciate the in vitro and in vivo methods used to determine the immunogenicity risk of silicone oil particles in drug product.
Summarize the impact of biotherapeutic coated silicone oil droplets on immunogenicity in in vitro and in vivo models.
