Pharma companies increasingly focus on self-injection devices as a mechanism for differentiating the drug product. As a result, Ypsomed has become a key partner for the successful development and commercialisation of the final combination product. Increased pressure on healthcare product prices, increased complexity in drug formulation, and more stringent regulatory scrutiny require us to equip pharma companies, in a flexible manner, with novel injection pens and autoinjectors customised to their individual needs.
Responding to these emerging requirements, Ypsomed has built up comprehensive platform products that each meet key customer needs yet are specifically designed to be modified into customer-specific products. The platform products enable flexible customisation while minimising project risks and shortening time to market.
We decouple the development of new platform products from the customer project and thereby move risk in-house to cover platform development and installation of manufacturing infrastructure.
Key capabilities in platform development
Ypsomed’s ability to supply tailored injection systems flexibly and efficiently for almost any customer need rests on four key capabilities:
Throughout all project phases, such as customisation to individual design requirements, human factor studies, clinical supply, or regulatory filing, all competencies are centered at Ypsomed headquarters in Burgdorf, Switzerland. This enables a richer and more efficient dialogue among experts, supports rapid learning processes across specialists, and helps to establish as well as sustain effective risk management programmes.
We leverage a comprehensive toolbox for device design and testing to accelerate the customisation of platform products while mitigating any technical risks. Our technical experts employ a range of cutting-edge tools and technologies, such as finite element analysis, rapid prototyping, design for manufacture, mould flow analysis, and human factors engineering. During all stages of development these methods help shorten timelines, improve device performance and meet regulatory requirements.
New platform development requires timely investment in manual, semi-automated, and automated manufacturing capacities specifically designed for platform products. Strengthening its manufacturing footprint in Switzerland and with a new site in Germany, Ypsomed leverages already available technical expertise and continuously improves the manufacturing process.
Our expertise as a consultant in drug delivery is highly valued by our customers. In particular, biotech and pharmaceutical companies working toward their first market introduction of an originator biologic or biosimilar may have little experience in evaluating drug delivery devices.
Based on our unparalleled expertise, our specialists have guided numerous customers through the design and development of innovative self-injection devices or the compilation and review of data required for product registration. We support our customers with know-how and device samples to conduct formative and comparative patient studies early on in the customisation process.
We serve as a single partner from customisation, to regulatory submissions, to the launch of the final product and customer support during later stages of the product life cycle. As such, we guide our customers through drug and device end-assembly. We closely work together with our network of dedicated machine partners and their ready-to-use automation concepts for low-, mid-, and high-volume capacity. For each device detailed machine specifications for end-assembly are available.
Ypsomed’s platform range
Today we offer one of the broadest ranges of pen and autoinjector platforms and support our customers in selecting the ideal device for their specific application.