Presented at ASMS, Indianapolis, IN, USA
Monitoring of critical quality attributes (CQAs) is currently performed using an array of analytical techniques. Many industrial players in biotherapeutics are exploring the adoption of innovative analytical approaches employing mass spectrometry (MS) to enable direct measurement of CQAs at the molecular level. In addition, MS-based methodologies offer the benefit of measuring many different quality attributes of a given biotherapeutic with a single test. These multi-attribute methods (MAMs) can potentially reduce development and manufacturing costs and at the same time increase aspects of product quality such as safety and efficacy.
We present an implementation of MAMs using Genedata Expressionist®, the enterprise software platform for data processing, analysis, and management of MS data. In this approach, dedicated workflows are tailored to measure the CQAs of a given biomolecule, while testing for impurities and searching for new features (new peak detection), as well as performing instrument qualification (system