In the years ahead, as market dynamics shift, major players in the in vitro diagnostics (IVD) sector will face the dual challenge of meeting rising demand for IVD products while continuing to innovate and maintain a focus on quality and reliability.

Our expertise in immunoassay development and manufacturing positions us well to understand the challenges immunoassay manufacturers may encounter as they scale to meet increased demand. 

This includes not only the final immunoassay products but also key biomaterials such as antigens and antibodies. 

Recently, one of our partners reported increased customer demand for a specific immunoassay. To support them, our operations team streamlined the production of a key monoclonal antibody (mAb) used in this assay to meet our partner’s needs effectively.

Our Biomaterial Manufacturing Department carefully selected the best cell culture system while maintaining existing expression and antibody specifications. 

After ensuring our standards for quality and performance remained unchanged, we transitioned from a hollow fiber to a wave bioreactor for optimized production. 

Outcomes 

As a result of our approach and transition to the wave bioreactor, we successfully tripled mAb production and reduced production time by 70%, all while fulfilling our partner’s operational demands and maintaining the stringent performance and quality standards of the immunoassay.