In today's dynamic IVD market, major players face a multifaceted challenge: meeting escalating demand while simultaneously driving innovation, maintaining reliability, and upholding unwavering quality standards. This balancing act is set to become even more critical in the years ahead as the industry continues to evolve.

At Werfen, we bring extensive experience in immunoassay development and manufacturing to the table. Our deep understanding of the IVD landscape allows us to anticipate and address the hurdles immunoassay manufacturers encounter. Whether you're grappling with production scale-up to meet growing demand for finished immunoassays or striving to ensure a consistent supply of vital biomaterials such as antigens and antibodies, we stand ready to provide the support and solutions you need to thrive in this competitive market. 

At Werfen, we work alongside our partners to help them meet their operational and quality needs.

Background 

Immunoassay development begins at bench scale during the R&D phase. Once this stage is complete, the product transitions to assay manufacturing, where the process is designed and validated based on demand forecasts. However, throughout an immunoassay's lifecycle, various challenges may arise. For instance, manufacturing volumes may no longer align with current demand, or production timelines may prove inefficient. In such cases, scaling up the immunoassay manufacturing process becomes a critical consideration to meet evolving requirements effectively. 

Our Approach