10.14.22 -- Evolving Design Space Requirements For Biologic Combination Products

High-volume parenteral delivery systems require consideration of both functional design and human factors to enable successful and consistent, reliable delivery to the target tissue. Learn more about the influence of needle inner diameter and length on delivery time across a range of fluid viscosities using a prototype autoinjector device.

Needle length and needle inner diameter are key parameters influencing injection force for a given injection time and solution viscosity. Reducing the injection force can influence patient preference, especially when high viscosities are injected. In this article, we discuss how the anticipated clinical benefits of 8 mm needles will support their broad adoption over time for subcutaneous drug delivery, particularly for use in chronic care settings.

New higher volume, higher viscosity formulations for subcutaneous injection are being developed as alternatives to traditional intravenous treatment, enabling chronic disease therapy in alternate settings. Swine are a proven physiologically similar and highly predictive translational model for examining injection feasibility, safety, and de-risking entry into costly clinical trials.

This successful early feasibility clinical study of the BD Libertas™ Wearable Injector demonstrated consistent functional performance as designed with broad subject acceptability across all demographic categories and injection sites tested with or without ambulatory movement during injection.