Key Highlights:
- SHL Medical has adopted a new reusable electromechanical autoinjector Elexy which changes how new drugs are trialled and commercialised, shortening these processes.
- The integration of SHL’s Needle Isolation Technology for cartridge-based delivery enhances Elexy’s control over factors like cannula gauge and injection depth, ensuring precise and reliable administration.
- The data collected during testing with Elexy reflects real-world use more accurately compared to other preclinical delivery options, such as needle sets fixed on the skin with adhesive.
We are in an era of unprecedented innovation in drug development, and the treatment possibilities have never been more exciting. But there’s a catch.
The tools we rely on to deliver these therapies are struggling to keep pace. For emerging medications requiring larger volumes, higher viscosities, or novel formulations, this mismatch can lead to costly delays and complex challenges during the preclinical and clinical trial phases, ultimately affecting pharmaceutical companies and patients alike.
Rather than solely focusing on expediting individual phases of development for drug-device combination products, Switzerland-based manufacturer SHL Medical has adopted a more holistic approach. Its new reusable electromechanical autoinjector, Elexy, changes how new drugs are trialled and commercialised, shortening these processes.
How it works
Elexy comprises a reusable power unit and an interchangeable drug cassette that can accommodate both prefilled syringes and cartridges, as well as various viscosities and volumes (up to 5 mL).
A patient simply loads a cassette, removes the cap, and presses the device against the injection site. An RFID tag on the cassette communicates the drug contents to the device, which automatically adjusts delivery parameters like depth and duration, simplifying the administration process for the patient and reducing the risk of errors.
Beyond its sustainability and patient convenience benefits, Elexy’s true impact lies in its advantages for pharmaceutical companies, particularly its ability to speed up time to market.
Streamlining preclinical trials
Mechanical autoinjectors come with unique limitations when supporting emerging drug therapies. Adjusting parameters like injection rate, volume, or depth during a preclinical trial is often impractical, given the lack of a programmable electromechanical power unit.
Elexy, however, easily accommodates these variations. Its reusable power unit allows researchers to adjust injection parameters by simply loading a new drug cassette. This adaptability supports in vivo studies, evaluating the performance and tolerability of large-volume injections.
Furthermore, as a hand-held device, the data collected during testing with Elexy reflects real-world use more accurately compared to other preclinical delivery options, such as needle sets fixed on the skin with adhesive.
SHL Medical
A simplified clinical phase
The conventional approach to developing combination products prioritises drug development, leaving the delivery mechanism as a later concern. This brings significant risks, uncertainties, and potential delays into the clinical and commercial phases, often requiring costly and time-consuming bridging studies.
An ideal strategy would involve using an autoinjector during clinical trials to evaluate the entire combination product, bypassing device-related bridging studies. However, this is impractical with single-use mechanical autoinjectors, since varying doses require significant component changes and lengthy timelines to develop new autoinjectors for each test condition.
As with preclinical research, Elexy alleviates this burden. By supporting various dose volumes, primary containers, and delivery rates, it makes dose-ranging studies as simple as loading different drug cassettes.
Additionally, using an autoinjector to generate clinical data – especially one with a programmable injection rate – produces datasets that are much more representative of commercial applications. As Elexy uses a standard primary container, the storage conditions and fluid path also align with the commercial application, leading to shorter bridges and faster time to clinic.
Elexy also avoids another problem: designing single-use mechanical autoinjectors requires specific details about the drug and injection, such as volume, rate, depth, and viscosity. This process involves extensive testing and validation, often causing delays or resulting in rushed, suboptimal parameters, or the drug launching in a form other than an autoinjector.
By using Elexy during clinical trials, delivery parameters can be optimised concurrently with drug development, paving the way for an immediate, low-risk transition into a mechanical autoinjector.
The data collected during testing with Elexy reflects real-world use more accurately compared to other preclinical delivery options."
Dynamic applications
Elexy’s advantages extend into commercial use, particularly for therapies involving multiple doses or chronic conditions. It is particularly effective for handling fluids that pose challenges for traditional mechanical systems, such as highly viscous liquids or injections requiring precise delivery rates.
The integration of SHL’s Needle Isolation Technology for cartridge-based delivery further enhances Elexy’s control over factors like cannula gauge and injection depth, ensuring precise and reliable administration, regardless of the primary container used.
For commercial applications involving multiple-dose regimens, Elexy offers a seamless transition. For example, a starter kit could include the power unit and larger-volume drug cassettes. Once the initial treatment is complete, the patient would then receive maintenance kits with smaller cassettes, all using the same power unit and loading and injection methods.
More generally, the device's reusability minimises waste, reduces component manufacturing and shipping demands, and lowers overall packaging, storage, and shipping costs.
In the ever-changing landscape of parenteral drug delivery, new systems are required to address unmet needs – both for patients and in product delivery. Elexy resolves these challenges head-on. It provides flexibility and efficiency in both preclinical and clinical settings, making it easier to evaluate new therapies and accelerating the timeline to market. At the commercial level, its reusability and adaptability provide practical benefits for drug manufacturers and patients alike.