Ypsomed has built up a comprehensive range of platform products, which allow faster and simpler development projects while minimising project risks and shortening time to market.
Customisation is key
During the customisation project the platform is adapted to the selected primary container, to formulation characteristics such as drug volume and viscosity and – in the case of autoinjectors – to the needle insertion depth. Different industrial designs allow further differentiation. For instance, the YpsoMate 2-step autoinjector is available in two fully industrialised designs (square and round) that are ergonomically proven and tested. Furthermore, different components such as the plunger rod, needle shield and spring strength are easily configured for each customer.
Efficient and flexible manufacturing
To keep the timeline short and project investments low, we have invested in manual, semi-automated and fully automated manufacturing capacity for our platforms. This allows our customers to access and source the device at a fraction of the overall cost compared to investing in bespoke devices and manufacturing infrastructure. During the customisation project the customer specific version is qualified and validated on the existing manufacturing equipment.
Support for drug and device end assembly
For the drug and device end assembly process, Ypsomed fully supports its pharma partners to help select the best possible solutions for their product and supply chain. To support the final device assembly step, Ypsomed works with a select number of renowned assembly equipment manufacturers to prepare machine concepts for manual, semi-automatic and fully automatic equipment for different capacity needs. This allows the pharma company to pursue the appropriate final assembly strategy objectively in combination with the inspection, labelling and packaging of the final combination product. We also collaborate closely with a number of CMOs that already have installed final assembly infrastructure for our platforms.
Further benefits
Some of the benefits of choosing an Ypsomed device platform as basis for device customisation are:
- Prototype devices are available off-the-shelf for handling studies
- Reduced project risks by configuring devices based on proven technology
- Fast availability of devices for clinical trials
- Short and reliable commercial project timelines
- Device-related information available for submission
- Competitive project costs and unit pricing
Conclusion
The demand for a specific self-injection device is compatible with the clear need for easy-to-access proven technology. Based on a well thought out design, that considers a broad range of customisation during early development of the technical concept as well as during the parallel development of the manufacturing process, our platforms can meet virtually all biopharmaceutical needs for a simple and attractive yet affordable self-injection device.
For more information, please see ONdrugDelivery Magazine, Pre-filled Syringe issue, October 2019, Orfeo Niedermann, “Success factors for the YpsoMate family of autoinjectors”.
