Needle-free drug delivery technology

Challenge

Increase the dose volume of a needle-free, pre-filled drug delivery technology.

Approach

Working across various departments and using our expertise in mathematical modeling and fluid dynamics, we tested the initial delivery system before carrying out industrial design and human factors studies leading to a range of prototypes.

Outcome

The result was a safe and ergonomic platform device that can target a range of delivery volumes without affecting manufacturing cost.

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Our client Zogenix Inc, a specialty pharmaceutical company focused on developing and commercializing products for treating pain and central nervous system (CNS) disorders, have developed and commercialized the DosePro® needle-free drug delivery technology.

DosePro® is a pre-filled, single-use, disposable needle-free subcutaneous delivery system for self-administration of liquid drug formulations up to 0.5mL in volume, including large molecule and high viscosity formulations.

In order to take advantage of the growing demand for treatments using higher dosage formulations, especially in the delivery of biologics, Zogenix wanted to develop a second-generation DosePro® system based on the same delivery principles proven by their 0.5mL system and in doing so, demonstrate comparable performance with up to 1.5mL of dose volume.

Our approach

Team Consulting was asked to carry out an overall system, sub-system, component and preliminary process development through to proof-of-principle based upon completion of a physical laboratory model and its testing.

This was undertaken concurrently with initial industrial design and ergonomics investigations leading to a range of device configurations and handling prototypes.

The underlying DosePro® technology instantaneously delivers a fine liquid jet with an initial peak of pressure to penetrate the skin before maintaining a subsequent lower-level pressure to deliver the dose subcutaneously, with user safety, tolerability and sensation comparable to delivery by a fine gauge needle and syringe.

Using our expertise in mechanical engineering, mathematical modeling and fluid dynamics, we were able to work with Zogenix to create a novel functional mechanism and replicate the target delivery profile from 0.5mL up to 1.5mL in delivered dose. In doing so, we successfully developed further patentable solutions in this area for Zogenix.

A range of device designs were explored which challenged the established means of user interaction.

Outcome

Via early-stage human factors analysis methods and industrial design input, we were able to create an ergonomic platform device which will be safe and intuitive to use, non-threatening and appealing to users. It is adaptable for use with the targeted range of delivery volumes, with little impact on manufacturing approach or cost.

Based upon the in-vitro work carried out by Team, Zogenix subsequently progressed the remaining development work which leads to final production design and launch.

Our innovative DosePro® technology is based upon our extensive research and development in needle-free drug delivery. We chose to work closely with Team Consulting on our next generation DosePro® as they also have considerable knowledge of needle-free drug delivery and auto-injector development.

Team were able to apply their expertise in industrial design and engineering to deliver an important extension to our technology platform, one which will provide sustainable competitive advantage to biopharmaceutical partners for many years to come. Their attention to detail, along with ingenuity and method of working are second to none.
John Turanin, VP & GM, Zogenix Technologies