Enhancing the Utilization of MALS in the Vaccine R&D Environment

The utilization of HPSEC-MALS-UV-RI to obtain absolute molar mass values of biomolecules in the vaccine R&D area within Merck has been an invaluable tool for years. As the speed of development continually increases, along with the complexity of the vaccine targets, additional ways of visualizing light scattering data have been examined to provide more comprehensive understanding of the manufacturing process. Utilization of alternative light scattering formalisms and orders of fit have been evaluated and optimized. Molar mass distribution tables, 3D plots, and cumulative weight fraction and conformation plots have been incorporated in the data evaluation process to link process changes with measured attributes. Examination of the MALS data in this format resulted in evaluation of alternative separation techniques including hydrodynamic chromatography (HDC) and asymmetric field flow fractionation (aF4) to take our product understanding to the next level. This presentation will share this approach of using MALS data to better characterize and understand macromolecules.