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Development and Preclinical Testing of a Rapid, High-Volume, Auto-Injector for Subcutaneous Administration with Recombinant Human Hyaluronidase

  • 0Halozyme Therapeutics, Inc., 12390 El Camino Real, San Diego, California, 92130, USA.
Aaps Pharmscitech +

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May 16, 2025

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May 16, 2025

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Summary

This summary is machine-generated.

High-volume auto-injectors (AIs) were developed to deliver 10 mL of immunoglobulin with hyaluronidase, improving injection efficiency and outcomes. This technology enables faster subcutaneous drug delivery for biologics.

Area Of Science

  • Biotechnology
  • Drug Delivery Systems
  • Pharmacology

Background

  • Subcutaneous injections are limited to low volumes (2 mL) due to hyaluronan (HA) barrier in tissues.
  • Recombinant human hyaluronidase PH20 (rHuPH20) enzyme depolymerizes HA, facilitating therapeutic dispersion.
  • Existing auto-injectors (AIs) are not designed for high-volume subcutaneous delivery.

Purpose Of The Study

  • To develop and preclinically test a novel high-volume auto-injector (HVAI) for subcutaneous (SC) drug delivery.
  • To evaluate the efficacy of co-administering immunoglobulin (Ig) with rHuPH20 using the HVAI.
  • To assess the impact of HVAI on injection site outcomes and delivery time.

Main Methods

  • Development of a prototype HVAI based on surrogate AI testing.
  • Preclinical testing in a miniature pig model delivering 10 mL of Ig with rHuPH20.
  • Evaluation of injection site parameters (back-leakage, bleb size, swelling, induration) and injection duration.
  • Mock clinical study simulating real-world administration conditions.

Main Results

  • The HVAI successfully delivered 10 mL of Ig with rHuPH20 in ≤30 seconds.
  • Co-administration with rHuPH20 improved injection site outcomes compared to Ig alone.
  • Injection times were up to 30% faster with the HVAI.
  • Mean injection durations of 19.8s (thin-wall 25G needle) and 30.0s (standard 25G needle) were achieved in mock clinical settings.

Conclusions

  • The prototype HVAI is feasible for rapid, high-volume subcutaneous administration of biologics.
  • Co-administration with rHuPH20 enhances the performance of high-volume subcutaneous injections.
  • This technology has the potential to expand therapeutic options for subcutaneous delivery.

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