The New Subcutaneous (SC) Landscape: Adapting Drug Delivery for Biologics Administration at Home

The subcutaneous drug delivery landscape is undergoing a structural transformation — driven by the growing use of biologics for chronic disease management, patient demand for home-based self-administration, and the healthcare system's recognition that decentralizing injectable therapy delivery reduces total cost of care and improves adherence. Large-volume subcutaneous injection volumes of 5–20 mL, previously exclusive to intravenous hospital administration, are now entering on-body wearable injector platforms that must be validated across CCI, break-loose and gliding force profiles, dose accuracy, delivery time, and hold-up volume — all while maintaining the stringent extractables and leachables, particulate, and sterility standards required for sensitive biologic formulations. This on-demand webinar, presented by Datwyler's Product Manager for Prefilled Syringes and Cartridge Solutions, provides a comprehensive market analysis and technical deep dive into this emerging segment. Topics covered include the market drivers accelerating the transition from IV to SC administration (patient comfort, improved adherence, cost savings for healthcare systems); the primary packaging requirements for plunger seals for sensitive biologics in large-volume SC systems (low E/L per ICH Q3D, CCI, low particulate and controlled silicone, device compatibility); Datwyler's expanded NeoFlex™ plunger portfolio covering 5 mL (pilot), 10 mL (commercial), and 20 mL (V9621, development) cartridge formats aligned to ISO 13926-1 draft standards; and a detailed collaborative case study with Stevanato Group (EZ-fill® 20 mL cartridge), LTS Device Technologies (Sorrel™ wearable platform, break-loose force limit calculation and dose accuracy testing), and Grand River Aseptic Manufacturing (fill-finish), presenting one-month stability data demonstrating break-loose forces compatible with Sorrel™ device vacuum limits, stable gliding forces at both 5–8°C and 20°C storage, dose accuracy within ±5% for all configurations, and hold-up volume minimization through cone plunger geometry.