This project has led to an improvement of ChromaCon’s MCSGP technology for purification of ADC’s. It also improved Alphalyse’s analytical methods for detailed antibody drug conjugates characterization and their drug-antibody-ratios (DAR). The developed analytical tools are beneficial for ChromaCon as well as other biopharmaceutical companies developing ADC’s and monoclonal antibodies (mAbs).
Antibody drug conjugates (ADCs) are site-directed monoclonal antibodies (mAbs) coupled to highly potent cytotoxins with great potential for targeted treatment of various types of cancer. The drug-antibody-ratio (DAR) is important for the dosing, but difficult to control in manufacturing and analytical characterization.
Study design used to evaluate Chromacon’s ADC purification
The analysis method for antibody drug conjugates characterization includes DAR profiling. UV LC-MS/MS determines the MW of the intact ADC, and of ADC subunits generated by IdeS cleavage.
The Eurostars project was a co-development between Alphalyse and ChromaCon. The two teams worked on ADC purification technologies and analytical methods for antibody-drug conjugates (ADCs).
You can read more about the analysis method, which Alphalyse is now offering for all biopharmaceutical customers, here; ADC conjugation analysis