Advanced drug development is at the forefront for establishing the efficacy and safety of the drug substances and products. In addition, the acquired data should be reliable, highly precise, and repeatable. Considering these requirements, size exclusion chromatography (SEC) combined with multi-angle light scattering (MALS), known as SEC-MALS, is the ultimate gateway for building specific analytical methods. As drug products and substances need to be tested for their stability over a certain period in drug development, SEC-MALS ensures high quality and reliable data generation. Furthermore, as other techniques face challenges in oligomerized drug products and substances, characterization through SEC-MALS method development produces distinct outcomes. Here, the promised opportunities of SEC-MALS are reported from performing a wide range of characterization of protein-based drug products and substances. Remarkably, the efforts are strongly correlated to the method development of SEC-MALS. The mobile phase, column length, and inline filter are the primary components for variation in the method development. The detection of refractive index (RI) and molecular weight distribution values such as Mn, Mp, Mw, Mz,  polydispersity, and high molecular weight (HMW) is analyzed and compared from a variety of standards and samples.

Highly specific analytical method development for advanced drug discovery through SEC-MALS

ACS Spring 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.