As the industry continues to see significant growth for drug products developed using cartridge-based drug delivery systems, there is a trend for pharmaceutical companies to evaluate more complex drug molecules, such as biologics, that require higher injection volume or viscosity. These biologics are typically intended for self-administration by the patient and integrate into either a prefilled syringe or cartridge as the primary container along with a delivery device to optimize safety, dose accuracy, and ease of use. The challenge, however, is ensuring the full delivery system (components, container, device) meets the evolving requirements.
Examples will be used to outline key decisions during primary container and device selection and to give an overview of new approaches in the development of next generation technologies for complex injections. Data will be shared on the key critical product requirements, such as performance, container closure integrity, and fill-finish considerations that can be used to support delivery system assessment and implementation at pharmaceutical companies. Additional examples will highlight various product and process improvements for cartridge-based drug delivery systems and how the inclusion of new technologies into delivery system selection can impact patient outcomes and mitigate risk during development.