Shenjiang Yu
Bioprocess Merck Co. & Inc, USA
Title: Characterization of Therapeutic Protein by Two Dimensional-LC (2D-LC) System
Biography
Biography: Shenjiang Yu
Abstract
Therapeutic protein, including monoclonal antibody (mAb), is one of the most rapidly growing area in many pharmaceutical companies. However, releasing and characterizing such molecule requires a number of analytical methods. Even for primary structure characterization, many different HPLC techniques such as ion exchange, size exclusion, reverse phase and hydrophobic interaction are involved. Unfortunately, each technique can only provide limited information based its own separation mechanism. Two-dimensional liquid chromatography (2D-LC) is a powerful tool for analyzing highly complex samples such as therapeutic proteins. 2D-LC is performed by online transfers of eluent from the first-dimension column to the second-dimension column. Ideally, both columns have orthogonal separation selectivity, thereby increasing the potential peak capacity to the product of the individual peak capacities. With this advanced technology, 2D-LC provides the possibility to combine two orthogonal methods and discover the correlation of the data obtained by different sepatration mechanism. This correlation provides critical information for total characterization of therapeutic proteins.