Our Approach

Developing new monoclonal antibodies (mAbs) for a specific target involves different project stages. At the end of the first stage, we conduct an initial screening to select the best mAb candidates among all the newly generated mAbs with our biomolecular interactions approach by analyzing mAb recognition patterns and kinetic properties. Although the best antibodies may have been selected for their immunoassay use, when moving forward with the new immunoassay development new challenges may arise since unexpected results appear in certain feasibility studies. Since our Biotechnology R&D team works alongside with our assay development team, we work in parallel towards solving potential hiccups that appear during a new immunoassay development project.

Our biotechnology R&D team performed a 360-degree assessment of both the upstream and downstream processes of the selected mAbs including the following variables:

 

To analyze the role of the selected variables in the performance of the mAbs the following analytics were put in place:

 

Outcomes

Thanks to the analytics that were optimized for the 360-degree assessment of the mAbs manufacturing process, we were able to determine what was the critical variable affecting critical parameters of the mAb in order to ensure the performance of the mAbs in the immunoassay in development with minimal impact in the planned timelines.

The coordination and constant communication between our R&D Biotechnology and Assay development teams were critical to succeed in this project and move forward with the new assay development project.

 

 

 

 

¹ Anion-Exchange High-performance liquid chromatography

² Size Exclusion Liquid chromatography

³ Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis