Automated, Workflow-based Quality Monitoring of Biotherapeutics: Implementing MS-based Multi-attribute Method (MAM) Approaches
ASMS 2020 Reboot
June 1, 2020
Currently, biotherapeutic manufacturers ensure final product quality by monitoring critical quality attributes (CQAs) using an array of analytical techniques. Although they are routinely used as release tests, these techniques do not generally measure attributes at the molecular level, and the multiplicity of methods leads to complex and costly process monitoring strategies and quality systems. As a result, numerous manufacturers are employing innovative mass spectrometry (MS)-based approaches that enable direct, simultaneous measurement of multiple CQAs at the molecular level in a single test. By providing more detailed information using a single analytical platform, so-called multi-attribute method (MAM) approaches can significantly reduce both development and manufacturing costs while at the same time, increasing product quality and enabling a true QbD approach for the development and production of biotherapeutics.
Genedata Expressionist offers a scalable enterprise software solution for MAM implementation. From discovery to production, the software enables the end-to-end MAM process, from product attribute identification to automated CQA monitoring and detection of unknowns. It facilitates communication across organizations, harmonizes MAM implementations across labs, enables complete automation, and supports deployment in regulated environments.