Biopharmaceuticals are structurally complex and pose numerous challenges in drug development. Globally, R&D companies are working to combat the complicated drug analysis necessary for large molecules, while trying to reduce laborious method development. Scientists at Merck have incorporated retention modeling into their strategy to simplify and accelerate their method development.
Their method development strategy involves screening a wide range of columns and mobile phases. The most promising column and mobile phase are selected from these, and a retention model is built by conducting a limited number of experiments. The retention model is then applied in silico to find the optimal temperature and gradient.
The workflow is practical, easy to use, and has been applied successfully to different techniques. Results show an excellent correlation between experimental and simulated chromatograms with a retention time difference of less than 0.5%. Additionally, the scientists at Merck have seen a dramatic reduction in method development time and “were able to reduce the entire method development from days to just half a day.”