Ypsomed Pulse

Prefilled UnoPen and reusable YpsoPen have both achieved impressive quantity milestones

UnoPen and YpsoPen are two of Ypsomed’s pen platforms developed and customized on behalf of various pharma customers for patients dependent on peptide hormones, in particular insulin but also GLP-1, hGH, FSH and PTH. Demand for these devices has increased over the last years and has now exceeded the total of 100 million UnoPen and 10 million YpsoPen delivered units. This achievement was celebrated with all colleagues involved at our Swiss facilities in Burgdorf and Solothurn.

Ypsomed in the platinum league

In our pursuit of making selfcare simpler and more accessible, we are excited to share the successful journey of two remarkable platforms: YpsoPen and UnoPen. These platforms have not only achieved significant milestones but helped transform the industry landscape for self-injection devices.

A legacy of innovation

The Product Area Pens (PA Pens) at Ypsomed has been at the forefront of developing cutting-edge devices that simplify the administration of liquid medications. For nearly 40 years, we have designed and manufactured a wide range of pens, from sophisticated electronic devices to cost-effective solutions. 15-20 years ago, our focus was on exclusive partnerships, with each pen developed exclusively for a specific therapy and customer.

Times have changed. In today's fast-paced world, this approach is no longer practical, both in terms of time and cost. Ypsomed recognised the need for innovation and efficiency, leading to the development of the versatile device product platforms: ServoPen, YpsoPen, UnoPen, and FixPen.

100 million UnoPens: A landmark achievement

Our journey with the UnoPen platform began in 2013 when we delivered the first UnoPens. Fast forward 10 years, and we are proud to announce that we have manufactured an astonishing 100 million UnoPen subassemblies. This remarkable milestone reflects not only our commitment to growth but also our dedication to supporting patients worldwide.

UnoPen is offered in more than 80 different variants and regulatory approvals for 14 different customers / drugs have been achieved, with many more to come

The success of the UnoPen platform can be attributed to its flexibility, which covers a wide spectrum of technical requirements. Ypsomed's ability to supply various quantities, both for clinical and commercial purposes, is facilitated by fully automated manufacturing equipment. Originally designed for insulin therapies, UnoPen has expanded its scope to encompass a diverse array of therapies, ranging from obesity and osteoporosis to gastrointestinal disorders and more. This diversity is mirrored in the numerous UnoPen configurations we offer, with more than 80 different variants available today and 14 drug approvals based on the UnoPen product platform.

How we achieved today’s manufacturing capacities

It took time, engagement, and commitment from key personnel in manufacturing and product management to build up the current manufacturing capacities. The first step involves setting up a ramp-up plan, then purchasing and qualifying manufacturing equipment. In a second step, we were pushed by our customers with long-range forecasts and purchase orders to develop and implement all aspects of high-volume manufacturing covering the whole variety of set-ups from single shift to 24/7.

Investments in large-scale automation and specialist expertise are key

Learning by Doing: Long-range forecasting and short-term order planning are key to achieving the required experience to reach our current output levels. Product quality has been maintained throughout this growth phase.

During the expansion phase we had to deal with unexpected challenges as well as basic needs not considered from the very beginning.  Examples include storage space, stock of packaging materials and injection moulding cooling systems becoming limited. Not only investments in infrastructure are needed, but the human organisation must grow. Machines can switch from 1 to 5 shifts, but the number of employees increases dramatically and leads to logistic challenges such as more changing rooms in controlled areas, night shift catering and managing shop floor meetings for shift handovers etc.

Now that we have reached round-the-clock manufacturing at a high efficiency and quality, is is easier to scale the same concept to even higher capacity at our other manufacturing sites to meet future demands. Projects for expansion in Germany and China are underway.

Meeting growing demand

The exponential growth of UnoPen sales since 2014 has been driven by our expanding network of pharma partners, with more than 60 customers across 22 countries today. Our ability to cater to various therapies and dose formats has contributed significantly to this growth.

Looking to the future, our challenge is to meet the ever-increasing demand for UnoPen while maintaining the highest quality standards. This requires seamless coordination between production and product management teams to ensure consistent supply to the markets.

10 million YpsoPens: Pioneering accessibility

Our success extends beyond the prefilled UnoPen. The reusable YpsoPen platform, introduced in 2013, has also achieved a significant milestone of 10 million YpsoPens for commercial and clinical use.

The CE- registered platform, a valuable choice for clinical studies and commercial projects

What sets YpsoPen apart is its adaptability. Initially, the majority of YpsoPen sales were in China, followed by Malaysia, India, and Russia. Our CE-registered platform opened doors for simplified approvals, making it a valuable choice for clinical studies and commercial projects.

Looking ahead, we are determined to expand our horizons further. Collaborations with pharma partners are underway, with plans to expand in territories in Central and Southeast Asia, MENA, and Latin America.

A big thank you to our teams around the world

None of these achievements would have been possible without the dedication and hard work of our teams in Switzerland, Germany and China. For over a decade, the teams of the Product Area Pens have ensured successful manufacturing, continuous development, and maintenance of product registrations, paving the way for further expansion.

Best regards,

Frank Schiffmann

Frank Schiffmann is Product Area Head Pens with Ypsomed Delivery Systems. He leads product teams taking care of the broad range of injection pen platforms at Ypsomed, be it CE marked reusable pens or components for pre-filled pens in high volumes. Frank has 25 years of experience in the development, registration and industrialisation of injection pens for pharma customers worldwide. He holds a BSc in Engineering and an EMBA in Innovation Management.

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