Our innovation team makes headway in solving critical challenges that we may face when developing immunoassays for our partners.

One critical challenge that we must face when developing and manufacturing a new immunoassay is the sourcing of raw materials. One of the most crucial is the material used to prepare calibrators and controls, as it comes from disease state plasma or serum. For some conditions, like certain metabolic and infectious diseases, sourcing of positive plasma or serum is a highly complex task due to the availability of samples and reproducibility from sample-to-sample.

We work alongside our partners to overcome challenges related to key raw material reliability

Our Approach

We decided to explore alternative and innovative methods of developing calibrators and controls for a new IVD immunoassay. With this goal in mind, we partnered with ArkAb to develop human chimeric antibodies that would mimic the native antibodies found in disease state human plasma. In order to obtain the human chimeric antibodies, Werfen supplied the recombinant antigens that are being used in the IVD assay.

Outcomes

The human chimeric antibodies obtained were tested in our OEM Technology Center with two different chemiluminescence immunoassays, showing good performance. The chimeric-based calibrators and controls could be equivalent to the plasma-based calibrators and controls, while reducing lot-to-lot variability and increasing robustness. We are always looking for innovative approaches to overcome challenges in immunoassay development and manufacturing, resulting in a higher quality of products while streamlining operations.