Created for home-use, the Gx Inbeneo® autoinjector enables easy, safe subcutaneous self-administration. With a pre-pressurized, cartridge-based design, the autoinjector can quickly and effectively deliver highly viscous biologic drugs.
Thanks to our platform concept, the Gx Inbeneo® can be easily customized to different drug viscosities and fill volumes up to 3 mL. We have extensive experience and can support your full development including documentation for regulatory submission of your final combination product.
If you’re developing large molecule drugs for subcutaneous administration, we understand that you’re considering numerous factors when evaluating your new device partner.
When you choose Gx Inbeneo® you can be confident of a safe, reliable, patient-friendly device that can be quickly adapted to your specific drug formulation. What is more Gerresheimer’s expertise in development, manufacturing, and regulatory submission reduces development risk and time-to-market.
Easy & safe for patients
2-step use with automatic needle insertion and drug delivery
Ideal for viscous biologics
Meets the challenges of sensitive molecules & high viscosity
Reduced risk & time-to-market
Platform concept for fast adaptation to different volumes & viscosities
Full-service partnership
Proven experience in device & primary packaging development & manufacturing
Quick and simple self-administration enables patients to integrate their therapy into their daily life.
Administration of a therapeutic drug is as simple as 1, 2, done!
The process
The patient simply removes the cap of the Gx Inbeneo® and pushes the end of the autoinjector against their skin. As the safety shield retracts, one end of the needle pierces the cartridge septum and the other end pierces the patient's skin. The fluid pathway is established, and delivery of the drug begins automatically. The patient can observe progress via the central inspection window or transparent top-casing. End-point is further indicated by an audible click. After usage the needle is secured by the safety shield ready for safe disposal.
Delivering biologic drugs subcutaenously in a home-care setting can be challenging. Sensitive molecules and viscous formulations place demands on the device. The Gx Inbeneo® autoinjector has been purpose-designed to solve these challenges.
Sensitive biotherapeutics, such as MAbs are vulnerable to aggregation, particularly with subcutaneous delivery*, which can result in a loss of biologic functionality. Features of the Gx Inbeneo® which address this include:
- A pre-pressurized design reduces or dissolves gas bubbles
- Use of Cartridges with baked-on siliconization which minimizes migration of silicone oil droplets into the drug
With an autoinjector that has a staked-in needle there is a risk that highly viscous drug products may cause needle clogging during storage. With the Gx Inbeneo® “dry” needle concept, the needle is separated from the primary packaging until use, which eliminates this risk.
We designed the Gx Inbeneo® with a focus on patient experience. This is why we created an innovative double-ended needle with different diameters at each end. The larger diameter end of the needle pierces the cartridge septum, and the other end has a smaller diameter to pierce the patient’s skin. The design reduces discomfort and enables higher viscosities of up to 100 cP to be delivered in less time than with a standard needle.*
The Gx Inbeneo® platform concept from Gerresheimer decreases time-to-market and development risk, thanks to:
Pre-filled syringe-based autoinjectors (PFS) employ a compressed spring held in place with a locking mechanism that must be reliably released at the moment of injection. In contrast, the unique pre-pressurized design of the Gx Inbeneo® employs a robust prefilled glass cartridge to retain the spring force, which makes the cartridge the force barrier. As no additional spring locking mechanism is required, any associated risk of failure is eliminated.
This innovative pr-pressurized design enables the use of springs strong enough to inject drug products with very high viscosity at volumes of up to 3 mL, based on calculations.
Patients can be nervous about self-injection with Gx Inbeneo, which may impact correct usage and adherence, however this is difficult to assess. We designed the Gx InMonit™ reusable smart add-on to support patients and provide data to pharma about injection events.
Gx InMonit:
-Reassures patients by guiding them step-by-step via an integrated AMOLED screen and audible signals
-Monitors and reports injection events, transferring data automatically via cellular network
-Can be fully integrated with a customized version of our Gx AdheraLink™ AI-driven two-way messaging application to further enhance patient support and insights.
The drug development process is long and complex. Formulations, concentrations and volumes are adjusted at different stages, which can make it tricky to define device requirements early. Therefore, we have designed the Gx Inbeneo® Platform Simulator together with our partner Midas Pharma. It helps you integrate device definition into the drug development process.
The simulator mimics the Gx Inbeneo® platform with different needle gauges, spring forces, and cartridge sizes available for testing. This enables:
We can supply the Gx Inbeneo® Platform Simulator for testing at your site.
As a leading systems and solutions provider for the pharmaceutical industry, Gerresheimer can support the full device dvelopment process including supplying primary packaging.
We reduce your workload as we manage the project from initial device definition and testing, through risk management, medical device documentation, sterilization, manufacturing, and volume production at one of our worldwide facilities.
We also support the regulatory submission process to US FDA or other bodies for your combination product
| Primary container | ISO 1.5 or 3 mL cartridge |
| Fill volume | 0.5 – 3 mL fill volume |
| Dimensions | L 195.75 mm x Ø 20 mm (with cap) |
| Needle design | Double-ended* |
| Patient needle | 25, 27, or 29 G |
| Needle insertion | Automatic, push-on-skin activation |
| Needle protection | Safety shield covers needle before & after use |
| Injection progress indicators | Visual with central window & transparent casing, audible with end-point click |
| System type | Pre-pressurized |
* Straight needle also available