Greater knowledge about the IVD biomaterial leads to increased immunoassays robustness, and therefore secures supply chain.

One of the most critical challenges that we face as an IVD manufacturer is to supply immunoassays that not only meet customer needs, but also comply with worldwide regulatory agency requirements.  Having an in-depth knowledge of a biomaterial through physicochemical and functional characterization is key to suppling immunoassays that meet both our customer’s needs and the highest quality standards.

Our experience in immunoassay development & manufacturing means we understand the challenges you might face as an immunoassay manufacturer and the critical factors to consider when producing a biomaterial.

You can rely in our experience in IVD immunoassay development & manufacturing, and in our expertise in physicochemical and functional characterization, in order to deliver robust IVD biomaterials and secure your operations.

Our approach

When characterizing a biomaterial, some attributes identified during the analytical characterization are critical in defining the performance of the assay, while other attributes may not play such an important role. It is of paramount importance to identify these critical quality attributes (CQAs) in order to optimize operations and to ensure consistency and quality in the IVD immunoassay supplied.

We recently faced the challenge of characterizing an IVD biomaterial for an immunoassay which had been transferred from R&D to production.

Outcomes

Our Biotechnology R&D team has developed analytical methods to assess the critical quality attributes for a monoclonal antibody that is being used in a novel immunoassay which has been transferred to manufacturing for routine production.

The results obtained with the analytical methods developed have helped improve our understanding of  the monoclonal antibody production process. Thanks to this knowledge, we have been able to define the key production and purification conditions for this antibody so they can be controlled during routine manufacturing.  

A greater knowledge of the IVD biomaterial contributes to streamline the routine operations while meeting our customer operational and quality needs.