Multiple Attribute Monitoring of Biopharmaceuticals Using Mass Detection

During biotherapeutic development, it is necessary to monitor properties of the therapeutic molecule and formulation that have been identified as critical quality attributes (CQAs) for product safety and efficacy. Currently, these analyses are conducted using optical detection. More recently, there is a trend among leading biopharmaceutical organizations to incorporate mass spectrometry into these routine assays, largely due to bimolecular complexity, but also as a means to assess more attributes in fewer analyses.

In particular, the industry is seeking to monitor post-translational modifications (PTMs), glycosylation profiles, and excipients with both UV and mass data by implementing multi-analyte or so-called Multi Attribute Methods (MAMs). These MAM assays are typically targeted toward monitoring downstream processes, but they are increasingly looked at as QC assays for lot release.

Incorporating MAMs into these environments requires the availability of analytical technologies that can be easily deployed and managed in GMP environments. Mass spectrometry, however, can require highly trained personnel and significant lab infrastructure—but recently this landscape has started to change. In this webinar, we will discuss the benefits of utilizing a cost-effective, compact, and user-friendly mass detector for routine monitoring of multiple biotherapeutic attributes. We will demonstrate through application examples that combining UV and mass detection delivers the orthogonal data points that can enable the direct and efficient implementation of MAM assays.