As co-lead of the MAM consortium, Rich Rogers brings a cross-industry perspective on why Multi-Attribute Method (MAM) is gaining momentum. As biologics become more complex, companies must monitor more product quality attributes across development and release testing, while legacy UV and single-attribute assays can limit product understanding and efficiency. This session will explore how USP <1060> and evolving industry expectations are helping bring greater structure and confidence to the MAM conversation. Rich will discuss what MAM is, why it matters now, and how collaborative industry efforts are reducing uncertainty around adoption. Attendees will gain a practical understanding of the scientific, regulatory, and business drivers behind the shift toward MAM—and why biopharma organizations should begin evaluating its role in their analytical strateg;y today.

Key Takeaways:

  • What MAM is and why it’s gaining traction now
  • How USP <1060> and evolving expectations are driving adoption
  • Limitations of legacy methods (UV, single-attribute assays)
  • Where MAM fits across development to release and stability testing
  • Business and scientific drivers for change
  • Biotherapeutic modalities are complex; MAM offers an opportunity to monitor multiple attributes in a single assay

Speakers

 

Rich Rogers, Ph.D

Rich Rogers, Ph.D

Director of CMC Strategy
Umoja Biopharma

Rich received his Ph.D. from the Johns Hopkins University in 2003. His research focused on SUMO modification of transcription factors. As a post doc, Rich joined the Institute for Systems Biology. At the ISB, Rich expanded his research on post translational modification by applying mass spectrometry to detect phosphorylation and other ubiquitin-like modifications in macrophages. In 2012, Rich joined the Analytical Sciences group at Amgen. At Amgen, Rich developed a mass spectrometry based multi-attribute method (MAM) for biotherapeutic characterization and release from QC. In 2015, Rich joined Just Biotherapeutics where he continued his work on MAM and started the MAM Consortium. In 2019, Rich joined BMS, in Seattle, where he applied the principles of MAM for cell-based therapies. Rich is currently at Umoja Biopharma, where he is leading the CMC strategy for multiple clinical programs.

Melissa N. Sato

Melissa N. Sato

BioPharma Software Workflow Manager
Life Sciences and Applied Markets Group, Mass Spec Division
Agilent Technologies

Melissa Sato brings over 15 years of biopharma experience specializing in analytical sciences, including mass spectrometry and chromatography for mAbs, BiTEs, fusion proteins, and oligonucleotides. She brings over 10 years of experience in Multi-Attribute Method expanding across development to GMP from her roles at Amgen and Thermo Fisher Scientific. At Amgen, she was an integral part of implementing MAM in GMP and co-authored a patent on sequential enzymatic digestion for MS analysis. Now at Agilent, Melissa leads the MAM for OpenLab CDS product and oversees BioConfirm and ExDViewer, driving innovation in biopharma mass spectrometry applications.”

Published

September 21, 2026

Created by

The Analytical Scientist Webinars