Subcutaneous drug delivery of high concentration antibody products - part 2: formulation, device options, and clinical bridging strategies for patient-centric commercial presentations.

Abstract

The landscape of drug delivery is undergoing a transformative shift. As demand for large-volume subcutaneous (SC) biologics continues to surge, the race to develop smarter, patient-centered combination drug products has never been more urgent. Here, we present a comprehensive analysis of SC combination drug product development from a commercial landscape perspective, with a focus on the dynamic interaction between delivery devices, biopharmaceutical formulation attributes, and clinical bridging strategies. From pre-filled syringes and auto-injectors to next-generation infusion pumps and on-body delivery systems, this review maps the full spectrum of delivery platforms, highlighting key factors from patient usability and tolerability to therapeutic performance and real-world preferences that drive trade-offs in the selection of one format over another. Furthermore, formulation strategies to support high-dose SC delivery via increased concentration, volume, or both are explored. Crucially, this review bridges the gap between bench and bedside, demonstrating clinical bridging strategies with multiple case studies that are essential for translating device-formulation decisions into outcomes that are both clinically meaningful and patient-friendly.