June 8, 2022
The multi-attribute method (MAM) leverages mass spectrometry (MS) for the simultaneous identification, quantitation, and monitoring of product quality attributes (PQAs) at the molecular level. By replacing multiple conventional analytical approaches, MAM provides significant operational cost savings while enabling a true Quality-by-Design (QbD) approach for the development and production of novel biotherapeutics. The implementation of MAM in Quality Control (QC) requires a new peak detection (NPD) data analysis procedure that provides identification of potential process- and/or product-related impurities.
We present an innovative automated data analysis workflow that delivers sensitive and truly unbiased NPD.