Ypsomed has built up comprehensive 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 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. The shell concept of YpsoMate Design allows fully customisable, individual industrial design. In addition different colours and colour combinations can be selected.

Efficient and flexible manufacturing

To keep the timeline short and project upfront investment 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 manufacturing infrastructure. During the customisation project the customer specific version is being 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 logistics 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 work together with a number of CMOs that already have installed final assembly infrastructure for our platforms.

Further benefits

Some of the benefits of choosing a device platform of Ypsomed as basis for device customisation are:

  • Prototype devices available off-the-shelf for handling studies
  • Reduced project risks by building device projects on proven technology
  • Devices quickly available for clinical trials
  • Short and reliable commercial project timeline
  • Device-related information available for submission
  • Reduced project cost and unit price

Conclusion

The demand for a specific self-injection device is not incompatible with the clear need for easy-to-access proven technology. Based on a well thought out design, that considered 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 2014, “From customer needs to commercial products – Fast and low-risk customisation of innovative injection systems”.