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Advancing Subcutaneous Delivery: Evaluation of Near-Body Auto-Injector Systems for High-Volume Biologic
Kallie Johnson1, Ryan Wangsnes2, Baylor Frantz2
1Halozyme kjohnson@halozyme.com.
PDA Journal of Pharmaceutical Science and Technology
|August 7, 2026
Summary
A novel Near-Body Injector (NBI) system enables hands-free, high-volume subcutaneous biologic delivery. Combining the NBI with hyaluronidase improved injection performance and reduced site reactions in a porcine model.
Area of Science:
- Biotechnology
- Drug Delivery Systems
- Pharmacology
Background:
- Subcutaneous (SC) biologic delivery is advancing to meet increasing volume and dose requirements.
- Conventional auto-injectors face limitations in volume and speed.
- Wearable on-body injectors (OBIs) and high-volume auto-injectors (HVAIs) have emerged to address these challenges.
Purpose of the Study:
- To evaluate the feasibility of a novel Near-Body Injector (NBI) system for high-volume SC biologic administration.
- To assess the performance of the NBI system in delivering immunoglobulin alone and with recombinant human hyaluronidase PH20 (rHuPH20).
Main Methods:
- The study utilized a porcine model to test the NBI system.
- The NBI system employed a standard winged infusion set and a mechanical priming mechanism.
- Immunoglobulin was delivered SC, both alone and co-formulated with rHuPH20.
Main Results:
- The NBI system demonstrated ease of priming and successful delivery of 10 mL SC.
- Co-administration with rHuPH20 significantly enhanced injection performance.
- rHuPH20 reduced delivery time by approximately 13%, eliminated back-leakage, and decreased swelling and induration at the injection site.
Conclusions:
- The NBI system shows clinical potential for hands-free, high-volume, high-dose SC biologic administration.
- This technology offers a viable alternative to conventional SC delivery methods.
- The use of rHuPH20 further optimizes SC delivery performance with the NBI system.
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