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  5. Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins - 10/13/2022
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Webcast | Virtual

Event Title
Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins
October 13, 2022

Date:
October 13, 2022
Time:
12:00 PM - 1:00 PM ET

About the Speakers

Sarah Rogstad, Ph.D. 
Senior Scientific Advisor 
Office of Testing and Research (OTR)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)

Dr. Sarah Rogstad is the Senior Scientific Advisor in the Office of Testing and Research (OTR) in the Office of Pharmaceutical Quality (OPQ). She received her Ph.D. in Pharmacology from the University of Colorado and her B.S. in Biology-Chemistry from Harvey Mudd College. She joined FDA in 2014. Her expertise is in mass spectrometry of protein, peptides, and complex products, and she is the lead for FDA’s multi-attribute method (MAM) research. 

Frances Namuswe, Ph.D.
Lead Chemist
Division of Biotechnology Review and Research III (DBRRIII)
Office of Biotechnology Products (OBP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)

Frances Namuswe is a Lead Chemist in the Office of Biotechnology Products (OBP), which conducts review, regulation, and research of biological products and biosimilar products.  She received a B.A. in Chemistry from Grinnell College and a Ph.D. in Chemistry from the Johns Hopkins University, where she used small molecules and synthetic peptide models to understand the active sites and reaction mechanisms of different metalloenzymes. Prior to joining FDA, she conducted postdoctoral research at the National Institutes of Health studying protein-protein and protein-DNA interactions involving zinc finger proteins. She has 10 years of experience assessing product quality of biological products including biosimilars and combination products characterized by various analytical methods including mass spectrometry. She also currently serves as one of the FDA representatives on the CASSS mass spectrometry committee. 

About the Presentation

The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins. Within the Center for Drug Evaluation and Research (CDER), the Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources have been developed to improve the FDA’s understanding of the approach.

Learning Objectives

  1. Discuss how the LC-MS based multi-attribute method can be used for quality control of therapeutic proteins.
  2. Discuss how the multi-attribute method can detect multiple product quality attributes or critical quality attributes within a single LC-MS run.
  3. Discuss the key considerations for implementation of the multi-attribute method, including risk assessment, method validation, new peak detection, and conventional method comparisons.

Webcast Recording

Event Materials

Title File Type/Size
Activity Outline FDA Grand Rounds: October 13, 2022 pdf (97.89 KB)
 
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