Authors
Kallie Johnson, Ryan Wangsnes, Baylor Frantz, Robert J Connor, Tara Nekoroski, Kevin D Swanson, David W Kang
Published in
PDA journal of pharmaceutical science and technology. Volume 80. Issue 4. Pages 470-471. Aug 07, 2026. Epub Aug 07, 2026.
Abstract
Subcutaneous (SC) delivery of biologics is evolving to accommodate the greater volumes and doses required for efficacy. Conventional handheld auto-injectors are constrained by volume and speed limitations, prompting the development of high-volume auto-injectors (HVAIs) and wearable on-body injectors (OBI). A Near-Body Injector (NBI) system offers a novel approach by combining the benefits of high-volume delivery with hands-free operation, without the need for adhesive attachment associated with OBI's by using a standard winged infusion set and a mechanical priming mechanism incorporated into the device. This study evaluated the feasibility of a NBI system in a porcine model, delivering SC immunoglobulin alone and in combination with recombinant human hyaluronidase PH20 (rHuPH20), an enzyme known to enhance SC dispersion and absorption.Results demonstrated that the NBI system was easily primed and effectively delivered 10 mL SC. Co-formulation with rHuPH20 significantly improved injection performance, reducing delivery time by ∼13%, eliminating back-leakage, and decreasing swelling volume and induration at the injection site. These findings support the clinical potential of NBI systems for hands-free high-volume, high-dose biologic administration, offering an alternative to conventional SC delivery methods.
PMID:
42567674
Bibliographic data and abstract were imported from PubMed on 08 Aug 2026.
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