Gx InPuls™ 10 mL Infusor Concept
Pioneering innovation for large-volume subcutaneous drug delivery
Our design concept for a 10 mL version of our Gx InPuls™ cartridge-based rechargeable on-body infusor platform responds to market requirements for self-administration of larger volumes.
The proven SensCore micropump technology employed in our infusor platforms enables precise dosing of small or large molecule formulations in programmable basal and bolus profiles.
Based on the design of our Gx InPuls™ 3 mL infusor platform, the 10 mL concept would offer similar sustainability and user-centric design features, enhanced with additional visual injection tracking.
Ready to be developed to your needs
By building on the proven capabilities of our 3 mL Gx InPuls™ infusor combined with a tested 10 µL SensCore micropump, we are confident that a 10 mL device would handle a broad range of viscosities and flow rates for larger infusions.
With a combination product based on our Gx InPuls™ 3 mL approved by the US FDA, you can rely on our expertise and experience in development, regulatory submission, and manufacturing at scale.
Contact us to discuss co-development possibilities to meet the specific requirements of your drug and therapy.
Benefits
Simple for patients
1-button operation with easy injection monitoring & safety features
Eco-design concept
Sustainable two-part design with multi-use, rechargeable unit
Based-on proven technology
Concept incorporates tested micropump technology
Full-service partnership
Proven experience in development & manufacturing
Gx InPuls 10 mL planned features
Rechargeable and recyclable electronics unit does not need to be sterilized
Pre-filled cartridge holds up to 10 mL of liquid drug
Sterile disposable unit containing fluid path delivered in blister pack
Designed for simple, gentle self-administration
The Gx InPuls™ infusor design concept is designed to empower patients to self-administer their therapy at home. They simply insert a prefilled 10 mL cartridge, click the device together and patch it onto the body.
Benefits of the concept would include:
Reduced risk of needle-stick injury and needle anxiety due to a concealed needle
Straight forward single button actuation with automatic needle insertion and retraction at the end of the infusion
Audible signals, 3x light indicators, an injection progress window, and occlusion detection for patient guidance
Precise, controlled drug delivery
Reliable, gradual, controlled delivery of a therapeutic drug in basal and bolus regimens is assured with our novel SensCore micropumps.
- Our patented micropumps deliver accurate dosing at low increments and can also handle high flow rate for large molecule delivery
- The valve structure in the SensCore pump mechanism provides double protection against free flow as there is only ever one valve open and when the pump is inactive both valves are closed simultaneously
- Your therapeutic drug is gradually infused over a pre-defined time period
Customizable for complex therapy regimens
The Gx InPuls™ 10 mL on-body infusor concept is designed to handle complex dosing profiles.
SensCore micropump technology combined with electronics already employed in other infusors would allow full control of dosing profiles, enabling complex bolus or basal regimens to be accurately programmed.
The two-part eco-design concept would employ a rechargeable, reusable unit with a target lifespan of up to 48 treatments. This would make it particularly beneficial for therapies to manage long-term health conditions.
Large molecule delivery
Delivering biologic drugs subcutaneously in a home-care setting can be challenging. Sensitive biomolecules and viscous formulations place demands on device technology. We have tested and optimized our novel SensCore micropumps which form the heart of the Gx InPuls™ platforms to confirm effective delivery of large molecule formulations at varied flow rates.
Sustainability built in
Useability and sustainability go hand-in-hand in our infusors. The two-part eco-design concept has a reusable unit (RU) housing electronics and a sterile disposable unit (DU) containing the needles. Patients benefit from sustainable device that can be assembled in a few seconds and worn comfortably throughout their day, without needing to travel to receive therapy.
Reuse – Cost & waste is reduced as the electronic components and batteries are housed in the rechargeable which is not part of medical waste
Recycle – At the end of its life, the RU is recyclable
Reduce – Size, weight & number of components have been minimized
Rethink – Only the DU needs to be sterilized
Full-service partnership
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
Intended Specifications
Drug suitability | Large and small molecule drugs |
Primary container | ISO 10 mL cartridge |
Needle system | Automatic insertion and retraction |
Needle protection | Safety shield covers needle before & after use |
System type | SensCore micropump |
Contact the expert
Andrew Moore
Global Director of Product Management & Systems Integration
