Presented at ASMS 2019, Atlanta, GA, USA
Biopharmaceutical firms adopt complex and costly process monitoring strategies and quality systems to ensure final product quality. This is achieved by monitoring critical quality attributes (CQAs) using an array of analytical techniques. Although routinely used as release tests, these techniques generally do not measure attributes at the molecular level. Consequently, many manufacturers of biopharmaceuticals are exploring innovative analytical approaches based on mass spectrometry (MS) that enable direct measurement of CQAs at the molecular level. MS-based methodologies also offer the benefit of measuring numerous quality attributes on a given biotherapeutic with a single test. Therefore, the multi-attribute method (MAM) has the potential to reduce development and manufacturing costs and at the same time increase product quality.