Ypsomed Pulse

For pharma companies to consider and invest in patch injectors, they need to be able to access reliable device technology and implement standard filling and final assembly processes that provide a turnkey solution that fulfils the needs of pharma and their patients / HCPs. The 10mL YpsoDose has undergone thorough internal testing and comparative studies with pharma customers and Ypsomed is committed to the successful commercialisation of YpsoDose as a new state-of-the-art patch injector.

Patient centric design improves therapy outcomes

YpsoDose is supplied to the patient or HCP pre-filled and pre-assembled to minimise the number of use steps and reduce the risk of misuse resulting in the handling steps «patch & inject». The pre-assembly of the RTU cartridge in YpsoDose is achieved using three main sterile barriers protecting the skin needle, cartridge needle and cartridge stopper.

All three sterile barriers are removed when the patch liner is released immediately prior to placement on the skin and start of injection.

YpsoDose uses a two-step approach – “patch” and “inject” – to reduce user error.

The use of a conventional electromechanical syringe drive mechanism allows YpsoDose to be orientated in any position comfortable to the patient on the desired injection site. The drive mechanism and related software algorithm are designed to modify the injection rate if the patient does not allow the drug to warm up to room temperature. There is also the option for the user to pause the injection e.g. due to pain, if this provides an overall advantage in terms of usability for the type of therapy.

State-of-the-art ready-to-use RTU cartridge maintains drug stability

10mL cartriQ® from SCHOTT Pharma

Ypsomed and SCHOTT Pharma have collaborated closely at their Swiss development and manufacturing sites to develop the 10mL cartriQ®. The 10mL cartriQ® is the perfect fit for use as it has unmatched inner surface properties (20% lower limit for hydrolytic resistance) and enables low levels of free silicone due to the state-of-the-art baked-on siliconisation process. In addition,  the 10mL cartriQ® offers 33% higher filling speed compared to other 10mL cartridge offerings allowing efficient processing on fill & finish lines.

The cartriQ® sterile barrier crimp cap plays a central role in maintaining the sterility of the RTU cartridge within the pre-assembled YpsoDose device. The cartriQ® sterile barrier is applied during the cartridge assembly and packaging process on SCHOTT Pharma’s new RTU cartridge manufacturing line in Switzerland.

Industrialising YpsoDose - Ready for clinical testing

Ypsomed has implemented cleanroom manufacturing at its Swiss facilities for both the sterile fluid path which is an integral part of the YpsoDose Needle Unit and the sterile barrier crimp cap. The Needle Unit is ETO-sterilised and the 10mL cartriQ® steam sterilised during their respective manufacturing processes at Ypsomed and SCHOTT Pharma. Sterility testing of the final assembled device has been completed internally and in collaboration with pharma clients during feasibility and clinical work.

YpsoDose device assembly is performed using a dedicated line in a clean device assembly environment in Switzerland. Assembly is co-located with Ypsomed’s insulin pump manufacturing which includes similar processes designed for electromechanical technologies. Dedicated design verification equipment has been developed and implemented at Ypsomed’s testing laboratories in Burgdorf Switzerland to facilitate the successful performance of ISO11608 testing for multiple customers. The cleanroom and device assembly infrastructure is designed to serve multiple clinical trials as well as low-volume commercial quantities.

Christian Esser Wiesemann

Christian Esser Wiesemann is YpsoDose Platform Manager at Ypsomed Delivery Systems. He has been with Ypsomed since 2016 in a number of roles in product and project management. Since 2020, his main focus has been on the YpsoDose patch-injector platform.

Mr. Esser Wiesemann holds a Diploma in Business Administration from RWTH Aachen, Germany. He has 11 year’s experience across many different positions throughout the supply chain and IT and has 7 years of experience in medical device industry.

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