The pace of biopharmaceutical development continues to accelerate,particularly with a large number of "breakthrough" drugs receiving accelerated review timelines.Regulatory agencies have recommended deploying a quality-by-design(QbD) approach for breakthrough and accelerated drug products.Product and process understanding,the foundation of QbD strategy,requires a deep understanding of the critical quality attributes(CQAs) at the molecular level,and insuring the desired product quality is met at the end of development cycle.Aiming to support QbD,gaining greater understanding of biotherapeutics,an increasing trend of moving mass spectrometry(MS) into lab settings traditionally associated with optical-based assays has been observed.MS coupled with liquid chromatography,as a well-accepted characterization tool,is proven to provide a wealth of multi-attribute information with greater confidence and depth of product attribute knowledge throughout the bioprocess development.This has facilitated the introduction of LCMS-based multi attribute monitoring methods to increase productivity.Challenges associated with these approaches include monitoring PQAs in large datasets,setting specifications,and transferring methods from development to QC.In this talk,we will demonstrate how these challenges can be addressed with a compliance-ready platform solution that seamlessly integrates in-depth characterization workflow and CQA monitoring workflow together.