Cross-linked silicone coating: a novel prefilled syringe technology that reduces subvisible particles and maintains compatibility with biologics.

Prefilled syringes (PFSs) offer improvements in the delivery of drugs to patients compared with traditional vial presentations and are becoming necessities in an increasingly competitive biologics market. However, the development of a product in a PFS must take into account potential incompatibilities between the drug and the components of the syringe. One such component is silicone oil, which has previously been suggested to promote protein aggregation, loss of soluble protein, and an increase in the particulate content of injectable formulations.

Silicone-oil-based subvisible particles: their detection, interactions, and regulation in prefilled container closure systems for biopharmaceuticals.

Recent increased regulatory scrutiny concerning subvisible particulates (SbVPs) in parenteral formulations of biologics has led to the publication of numerous articles about the sources, characteristics, implications, and approaches to monitoring and detecting SbVPs. Despite varying opinions on the level of associated risks and method of regulation, nearly all industry scientists and regulators agree on the need for monitoring and reporting visible and subvisible particles. As prefillable drug delivery systems have become a prominent packaging option, silicone oil, a common primary packaging lubricant, may play a role in the appearance of particles.