Mar 20, 2017 – MSDG Meeting

Since the introduction of the first recombinant DNA-derived protein insulin in the 1980s and the launch of Interferons and Interleukins in the 1990s, biologics market has shown a healthy growth. This is largely due to advances in recombinant DNA technology that have provided the means to produce therapeutic proteins. Mass spectrometry is uniquely positioned to cope with additional challenges for the analysis of biologics, due to its analytical sensitivity and specificity. This presentation will present current status and trends in MS characterization of biologics, including primary structural analysis and higher order structure characterization.

High resolution analytical technologies are moving out of the realm of characterization and into the regulated environments of late development, manufacturing and QC organizations. Analytical managers are now challenged to not only develop an effective characterization strategy, but participate in the lifecycle planning of those assays as they evolve into attribute monitoring, and validated release assays for a commercial product. Harmonization of platforms across these organizations has remained a challenge to this process, but the development of platforms for both high resolution and routine nominal mass detection that can be deployed across an entire organization have fueled great interest progressing LCMS analysis later in development and into QC organizations. While peptide-centric monitoring of multiple product variants has recently generated great interest and concerns, there is already a progression of developing and validating intact/subunit mass profiling QC release assays. In this seminar, we will discuss the benefits of applying the HRMS QTof platform under UNIFI for comprehensive primary structural characterization in support discovery and development efforts, transitioning this platform into regulated late development with a mix of targeted monitoring and new variant identification workflow, and multiple strategies at the intact/subunit mass and peptide map level for effective deployment of critical assays into a QC-lot release environment.