Can Cross-Linked Siliconized PFS Come to the Rescue of the Biologics Drug Product?

Silicone can present a challenge during the development of a biologics drug product particularly in pre-filled syringe (PFS). Due to silicone related challenges, substantial changes in components and manufacturing of the PFS are being sought. Cross-linking of the silicone being one of them, can help reduce mobilization of the silicone into drug product whilst retaining its functionality of lubrication during injection.