Wed-11 | New aspects in the development of Multi-Attribute Method (MAM) 

Join Biotherapeutics Interest Group Presiders: Hao Zhang, Rich Rogers, and Da Ren as they talk about how the advances of new indications and therapeutic modalities in the pharmaceutical industry drive the development of new analytical methods that provide enhanced insights in a more efficient manner. In the past decade, liquid chromatography (LC)-mass spectrometry (MS)-based Multi-Attribute Method (MAM) has successfully demonstrated its capability in replacing traditional chromatographic and electrophoretic testing methods for monitoring both product and process quality attributes (Rogers et al., AAPS J, 2017). As we enter a new decade of technology and method development, MAM and its original initiation of MS in QC are facing many new aspects. Recent advances in mass spectrometry instrumentation have provided novel opportunities in reforming the original MAM. The industry-wide MAM Consortium inspires method development and diversity for new MAM approaches that are fitting into different application in biopharma R&D schemes. New/multiple enzyme digestion approaches, subunit analysis-based MAM, fully automatic sample preparation, compact MS for MAM in QC and new data acquiring approaches like PRM are presented recently. The biotherapeutic interest group workshop offers a forum for members to share and discuss those new aspects in the development of MAM.