Presented at WCBP, Washington, DC, 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.