Portal Instruments Demonstrates Feasibility of Needle-Free Injection for High-Viscosity, High-Volume Biologics

Cambridge, MA - 26 August, 2025 – Portal Instruments Demonstrates Feasibility of Needle-Free Injection for High-Viscosity, High-Volume Biologics

Portal Instruments, a leader in patient-centric drug delivery innovation, is pleased to announce the publication of a collaborative study in the journal Bioengineering & Translational Medicine (DOI: 10.1002/btm2.70063), highlighting the viability of its next-generation, needle-free injector (NFI) for subcutaneous administration of high-viscosity monoclonal antibody (mAb) formulations.

Study Highlights

• The proprietary Portal Instruments 2.0 mL needle-free injector—based on the PRIME® platform—delivered 2.0 mL of a 50 cP mAb formulation subcutaneously using a finely collimated, high-pressure jet, all controlled by an electromechanical, computer-regulated actuator.
  
  
• Product Integrity Maintained: Post-injection analysis showed minimal changes in antibody purity, aggregation, color, turbidity, and charge heterogeneity compared to a standard 27-gauge needle and syringe (N&S).
  
  
• Precise Delivery: In an ex vivo pig skin model, Portal’s NFI accurately delivered the full 2.0 mL dose into the subcutaneous layer, though with an approximately 8% higher fill volume than the N&S.
  
  
• Comparable Pharmacokinetics: In a Yorkshire pig in vivo model, critical pharmacokinetic parameters—including clearance (CL), peak serum concentration (Cₘₐₓ), time to Cₘₐₓ (Tₘₐₓ), AUCₙₙₙₙₙₙₙ, and half-life (t₁/₂)—were all within 1.2-fold of those achieved with needle-based injection, with no significant difference in Tₘₐₓ. Bioavailability was nearly identical: 80.0% for NFI vs. 79.5% for N&S.
• Excellent Tolerability: No concerning clinical signs or injection-site reactions were observed in the treated animals.

About Portal Instruments
Portal Instruments is transforming biologic drug delivery with its re-usable, electro-mechanical PRIME platform. Through rapid, precise, and comfortable delivery of high-viscosity biologics—at home or in clinical settings—the technology offers advantages in patient compliance, safety, and environment.

This study marks a major milestone in Portal’s mission to bridge the gap between intravenous and subcutaneous biologic therapies while prioritizing patient experience and advancing home administration capabilities.

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