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102 BIOTECHNOLOGY


Waters was selected for numerous reasons, according to Flory. Te Biopharmaceutical Platform Solution with Unifi delivered results comparable to HIC and other reference data for the demo sample.


Traditional ADC strategies yield DARs from zero to eight drugs per antibody, and it has been shown that high drug loads are lost to solubility and PK issues, while low loads can lack efficacy. Igenica needed a dedicated ADC


platform to quickly determine the ratio and provide feedback to the scientists in development and the Unifi scientific information system can automate DAR calculations. Te software’s flexibility enables chemists, who currently tend to rely on manual calculations, to generate those values as part of data processing and reporting during routine analysis.


Igenica’s chemists like to run sets of denatured samples (reversed-


phase LC/MS) overnight and corresponding native samples (non-denaturing SEC-MS) by day. Te integrated Waters solution, with its facile column switching, streamlines setup and method execution to run samples quickly.


Te new solution has provided Igenica chemists with analytical capabilities that allow them to move forward – or quickly abandon – ADC candidates as cancer therapies, which can


greatly accelerate their research.


Te platform is also being applied to intact mass ADC profiling and Igenica is exploring the system’s flexibility to perform peptide mapping and glycan analysis on their biotherapeutics.


For more information ✔ at www.scientistlive.com/eurolab


Sharon Goodkowsky is with Waters in the USA. www.waters.com/adc


Fig. 2. This representative report from Unifi illustrates the software’s ability to provide automated calculation of drug-to-antibody ratio (DAR), which includes total DAR and distribution per sample, as well as a summary table of average total DAR, DAR distribution (%), and mean and %RSD.


www.scientistlive.com


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