Biopharmaceutical companies today not only have to grapple with the complexity inherent to large molecules, but they must also contend with an increasingly complicated landscape of patent cliffs, market forces, and regulatory challenges. With all of these dynamics in play, biopharma developers need to understand their molecules better and faster than ever before. This desire for rapid innovation is resulting in an exponential growth of required analytical testing to bring their drugs to patients.
Companies are exploring LC-MS based techniques like multi-attribute monitoring (MAM) which enable researchers to detect and directly measure multiple quality attributes in a single analysis, enabling streamlined data generation and more productive analytical workflows. These LC-MS technologies have needed to become robust, reproducible, easy to operate and deployable to be placed at the points of decision making.
Our solution to this industry-wide challenge is a built-for-purpose system that enables a larger population of scientists to routinely access high resolution mass spectral data. Waters offers the first SmartMS enabled biopharma solution which is comprised of innovative technologies- UPLC, Mass Spectrometry, chemistries and sample preparation, and compliance-ready UNIFI software.
Application areas include:
- Intact Mass Analysis of Proteins and Oligonucleotides
- Monoclonal Antibody (mAb) Subunit Analysis
- Released N=Glycan Analysis
- Peptide Mapping/Multi-Attribute Monitoring (MAM)
