Protein-based drugs are characterized with a plentitude of different analytical approaches and methods. Each of these methods provides insight into a certain aspect of the molecule. For example, capillary Gel Electrophoresis (cGE) provides detailed information about the relative impurity content and the purity of an analyte. Especially for low molecular weight species, cGE shows high resolving power and a reproducible relative quantification.
One of the key aspects is not simply just to quantify the different detected signals but also to identify if they originate from the drug substance itself or from impurity compounds out of the production process. In the past, direct characterization and identification of these species has proven to be challenging.
In this webinar, we present an appropriate solution: combination of Hydrophilic Interaction Chromatography (HILIC)-MS and cGE. As cGE cannot be efficiently coupled to MS directly, we optimized HILIC to produce the same chromatographic peak pattern that was observed as electropherogram during cGE. The HILIC is coupled to MS for identification of the single species.
Using the combination of HILIC-MS and cGE, the peaks detected in the cGE electropherogram can be identified and assigned to the full-length protein, specific degradation products or production process-related species. We will also present, how fractionation enables the usage of additional methods like peptide mapping on the peaks of interest. With the combination of these powerful techniques, we enable our customers to recognize impurities within their products.
Join our webinar 10.09.2020 8:00 AM (San Francisco) 11:00 AM (Boston) 5:00 PM (Frankfurt) 11:00 PM (Singapore)