Biokit immunoassay manufacturing capabilities oriented to provide high quality products to our partners.

Nowadays we are facing major changes in the IVD industry. We are in a complex healthcare situation around the world where IVD is playing a key role. This situation has caused that major IVD players have to meet an increase in demand for certain immunoassays. The increase in demand also implies that some critical stages in the manufacturing process of an immunoassay may suffer stress. One of these stages is the filling of the different components of a chemiluminescence-based immunoassay (CLIA).

In Biokit, we work together with our partners to provide high quality products to the market.

Our Approach

One of the most critical steps of the chemiluminescence-based immunoassay manufacturing is the filling process, in which the uniformity of particles is key to guarantee the quality of the product. Therefore at Biokit we have an extra step in the process, consisting of real-time monitoring of the concentration of the particles. This in-process control ensures that the entire filling process is within the required specifications.

Outcomes

Due to the addition of an in-process control in the filling process of chemiluminescent immunoassays, the vial-to-vial variability has been reduced, leading to an overall improvement in the quality of the immunoassay.