Our design concept for a 5 mL version of our Gx Inbeneo cartridge-based atuoinjector platform responds to the market trend for self-administration of biologics in larger volumes.
Based on our Gx Inbeneo 3 mL autoinjector platform, the 5 mL concept incorporates the same rigorously tested technology and confirmed user-centric design features.
By building on the technology and usability features of our 3 mL Gx Inbeneo, the 5 mL version shares most components, and is suitable for high viscosities, at even larger volumes.
Read our whitepapers for the results of the extensive testing of the Gx Inbeneo 3 mL autoinjector pre-pressurized concept as well as deliverable volume and viscosity ranges.
Whitepaper: Responding to the Challenges of Biologics
Whitepaper: Testing proves Gx Inbeneo Concept
Whitepaper: Extending volume & viscosity limits
Whitepaper: User-centric development
Contact us to discuss co-development possibilities to meet the specific requirements of your drug and therapy.
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
Based-on tested technology
Concept incorporates the same technology & components as the 3 mL Gx Inbeneo
Full-service partnership
Proven experience in device & primary packaging development & manufacturing
The Gx Inbeneo 5 mL would be based on the same unique pre-pressurized design as the 3 mL. The design employs the prefilled glass cartridge to retain the spring force, making it the force barrier and enabling the use of
springs strong enough to inject very high viscosities.
The design also features a separated “dry” needle that only pierces the septum when pushed against the patient’s skin. This allows an identical front assembly to be used for the Gx Inbeneo 5 mL as the 3 mL. The rear housing of the autoinjector would only need to increase minimally in diameter to accommodate the larger cartridge and spring.
The Gx Inbeneo has been designed to empower patients to self-inject at home enabling them to integrate their therapy into their daily life.
Benefits of the 5 mL concept include:
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:
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 to be delivered in less time than with a standard needle.*
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 | 5 mL cartridge |
| Fill volume | 3 mL – 5 mL fill volume |
| Dimensions | L 196.5 mm x Ø 22.1 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
Moritz Mond
Senior Product Manager
