Becton, Dickinson and Company (BD) has announced a trial utilising the BD Libertas wearable injector for subcutaneous delivery of biologics.
The decision to employ the injector in this first pharmaceutical-sponsored combination product trial comes after positive results from more than 50 pre-clinical and clinical studies carried out by BD.
The company noted that a device clinical trial among these studies highlighted the performance, with all subjects indicating their willingness to use the injector if prescribed.
BD Pharmaceutical Systems worldwide president Patrick Jeukenne said: “This trial demonstrates BD’s commitment to helping pharma companies by advancing large-volume injection science, ensuring therapies are accessible and patient-friendly by offering more efficient and convenient options for biologics.
“BD’s enhanced testing capabilities acquired through ZebraSci and the proven capabilities of the BD Libertas Wearable Injector technology further position BD as an innovative leader in drug delivery.”
The prefilled, patient-ready-to-use system is said to support delivery of high-viscosity biologics of up to 50 centipoise.
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By GlobalDataIt comes in two volume configurations, 2mL to 5mL and 5mL to 10mL, catering to various therapeutic needs.
Additionally, its design features a simple “peel, stick and click” mechanism, eliminating the need for user filling or assembly.
The injector also includes a transparent window for monitoring the drug delivery, push-button activation, along with a colour-coded status indicator.
The company is currently validating fill-finish and final assembly processes with several contract manufacturing organisations (CMOs) to ensure support for pharmaceutical collaborators from development to commercial-scale production.
As a device component intended for drug-device combination products, it is not subject to US Food and Drug Administration (FDA) 510(k) clearance or European Union (EU) CE mark certification.
In April 2025, BD secured the 510(k) clearance for the Phasix ST umbilical hernia patch, enabling the product’s commercial launch.
