Senior Scientist Merck & Co., Inc. Kenilworth, New Jersey
The complex composition of PS-80 poses a significant characterization challenge for its use in the pharmaceutical industry. PS-80 degradation could lead to particle formation in biologics drug product (DP), which directly impact the product quality and cause potential risk to patients. A Liquid chromatography–mass spectrometry (LC-MS) based method has been developed for characterization of the complex composition of PS-80. This approach, combined with the utilization of Genedata Expressionist for data processing, offers a streamlined ion map for a comprehensive identification of PS-80 species. The graphical representation of the data in two dimensions facilitates the visualization of these characteristics, enabling a prompt diagnosis of degradation pathways. The method also offers a simple solution to identify the root causes of PS-80 degradation, which provides critical information to develop PS-80 control strategy to ensure the shelf life of DP.
Learning Objectives:
Upon completion, participants will acquire the knowledge necessary to effectively implement the method development of Reversed-phase liquid chromatography coupled with charge-reduced electrospray mass spectrometry.This particular method plays a crutial role in minimizing and streamlining the abundance of data points due to the intricate nature of PS-80's composition.
Upon Completion, participants will have the opportunity to comprehend the advantages of utilizing Genedata, a powerful software tool, in generating two-dimensional ion density mapping. This mapping technique greatly facilitates the characterization and profiling of PS-80 species, enabling a deeper understanding of their properties and behavior.
Upon completion, participants will gain insight into the practical application of this tool in visually differentiating between PS-80 degradation caused by enzymatic degradation and oxidative degradation. This knowledge will enable researchers and scientists to effectively identify and address specific degradation mechanisms, leading to more informed decision-making and improved product quality.