Moving your portfolio one step beyond: Transitioning from native to recombinant proteins for IVD kit development

Innovation lies at the core of our mission, driving how we connect complex clinical challenges with cutting-edge ideas and enabling tools to generate new concepts in immunoassays and biotechnology. We are committed to advancing diagnostic science through the development of novel immunoassay that addresses unmet clinical needs and ultimately improve patient outcomes. By integrating scientific rigor, technological insight, and a deep understanding of real-world clinical demands, we design immunoassays that are not only technically robust but also meaningful in practice—delivering solutions that make a tangible difference in healthcare.

Our innovation efforts focus on:

• Creating new biomaterials
• Designing innovative immunoassays
• Integrating advanced technologies
• Collaborating with leading institutions and partners

Looking for innovative approaches to move your immunoassay portfolio one step beyond

The selection of primary raw materials, whether antigens, proteins, or antibodies, plays a pivotal role in determining the performance of any new immunoassay. Historically, first-generation immunoassays have often relied on native proteins, which have proven effective in achieving the performance standards required for in-vitro diagnostic (IVD) applications.

However, the use of native proteins and antigens is not without challenges. These materials are inherently subject to significant lot-to-lot variability, which can impact assay consistency and reproducibility. In addition, their production is frequently costly, time-intensive, and operationally complex.

As the field continues to evolve toward more efficient and scalable immunoassay solutions, addressing these limitations has become increasingly important. Improving raw material consistency and optimizing production processes are key steps in ensuring robust, reliable diagnostic performance across diverse clinical settings.

In Werfen we work towards moving your immunoassay portfolio one step beyond by providing new biomaterials for the IVD industry. In this webinar we share two cases of how we have developed two different recombinant proteins to replace native proteins used in existing immunoassays.

Find more details about this project in our Immunoassay Webinar Series: Transitioning from native to recombinant proteins for immunoassay development.