ArticleBioengineering & translational medicine2026
Feasibility and pharmacokinetic evaluation of a needle-free injector for delivering high concentration antibody formulations.
Article in Bioengineering & translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
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Authors and funding
18 authors.
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No grant is acknowledged in the PubMed record.
Abstract
The increased preference amongst health care providers and patients for subcutaneous (SC) administration of biologics has necessitated the development of higher concentration formulations to maintain doses similar to intravenous (IV) products. These formulations possess manufacturing and administration challenges; particularly high concentration monoclonal antibody (mAb) formulations push the limit of injectability. Furthermore, patient-centric considerations, such as pain and fear of needles (trypanophobia), can lead to compliance deviations for long-term treatments. This study presents a set of evaluations of a novel computer-controlled, needle-free injector (NFI) design that can deliver 2.0 mL of a high viscosity (50 cP) mAb formulation into the SC space. Critical attributes such as antibody purity, aggregation, color, turbidity, and charge heterogeneity were evaluated before and after ejection and demonstrated minimal change compared to ejection from a 27-gauge needle and syringe (N&S). Furthermore, the device functionality was evaluated in a novel ex vivo pig skin model, demonstrating the ability to accurately deposit a 2.0 mL dose at an appropriate depth in the SC tissue, though requiring 8% greater fill volume than an N&S. An in vivo Yorkshire pig model was used to understand the pharmacokinetic (PK) profile of the NFI in comparison to a N&S. Clearance (CL), the observed peak concentration in serum (
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