When Size Matters: Evolution of Self-Delivery Solutions for Subcutaneous Administration

The pharmaceutical industry's shift toward large-volume subcutaneous (SC) self-administration of biologics — driven by the growing use of high-viscosity mAbs, biosimilars, and GLP-1 receptor agonists requiring ≥5 mL doses — demands primary container sealing solutions and wearable delivery devices validated together as integrated systems, not as isolated components. This on-demand session, presented at Pharmapack 2026 by Datwyler's Product Manager for PFS and Cartridge Solutions alongside Stevanato Group's Product Manager for Cartridge Platform and LTS Device Technologies' Executive VP of New Business Development, presents the results of a pre-verified platform collaboration covering the full range of large-volume SC delivery scenarios. The complete NeoFlex™ product range is mapped across the SC delivery landscape: V9555 for 10 mL large-volume auto-injectors in ISO 11040-4:2024 syringes; V9547 for 5–10 mL on-body cartridge devices with 19.05 mm internal diameter; and V9621 for 20 mL on-body devices with 23.85 mm internal diameter. Stevanato Group's EZ-fill® platform across 5 mL, 10 mL, and 20 mL is detailed with full dimensional specifications. The core dataset — generated by LTS from actual Sorrel™ device vacuum force measurements on 4,905 device assemblies — establishes statistically derived maximum allowable break-loose force limits of 17.728 N for 5/10 mL systems and 27.788 N for 20 mL systems. Datwyler's one-month BLF and GF stability testing across three cartridge sizes at both 5–8°C and 20°C storage, both steam and gamma sterilization, confirms all maximum BLF values remain below device limits and gliding forces remain stable throughout. Eight complete test configurations across 4 mL, 10 mL, and 20 mL volumes at 1 cP and 60 cP viscosities confirm dose accuracy within ±5% for all configurations, patient-centric delivery times, and hold-up volumes of 0.139 mL (20 mL cartridge) and 0.132 mL (10 mL cartridge) — both well within specification limits.