Best Practices for Mass Spectrometry-Based Multi-Attribute Method (MAM) for Therapeutic Proteins: USP General Chapter <1060>

MAM for analytical testing of biotherapeutics is gaining traction due to its potential to improve efficiency and provide more detailed information on PQAs. This presentation will provide an overview of USP’s proposed eneral Chapter <1060> Mass Spectrometry Based Multi-Attribute Method for Therapeutic Proteins

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Event Overview:

Multi-Attribute Method (MAM) for analytical testing of biotherapeutics is gaining traction due to its potential to improve efficiency and provide more detailed information on product quality attributes (PQAs) as compared to conventional methods. This webinar will focus on the development of USP standards and tools to support MAM for product characterization and quality control. Considerations that impact the quality and consistency of MAM, approaches to enhance the method robustness, and case studies will be discussed.

Key Learning Objectives:

• To understand the considerations for implementation of MAM for therapeutic proteins
• To understand the comparison of MAM against traditional methods
• Case studies of MAM applications for monoclonal antibodies

Featured Speakers:

Li Jing
Principal Scientist, Global Biologics
United States Pharmacopeia

Dr. Li Jing is a Principal Scientist in USP’s Global Biologics Department. Dr. Jing leads a team of liaisons working with the USP Expert Committees and multiple expert panels for proteins, peptides, and carbohydrates to develop standards that support biopharmaceutical quality assessment and development. Recently, Dr. Jing worked with the USP MAM Expert Panel and developed General Chapter <1060> Mass Spectrometry Based Multi-Attribute Method for Therapeutic Proteins.

Dr. Jing holds a Ph.D. in Analytical Chemistry from the University of Georgia and a B.S. in Chemistry from Fudan University. Dr. Jing has worked for several biotechnology and pharmaceutical companies, focusing on the development of protein therapeutics and vaccine candidates.

Da Ren
Founder
BioTherapeutics Solutions

Dr. Da Ren is the founder of BioTherapeutics Solutions, an analytical solution provider for the biopharmaceutical industry. Prior to starting BioTherapeutics Solutions, he was a Scientific Director at Amgen in charge of analytical platforms and global strategies and implementations of the Multi-Attribute Method (MAM), which has been accepted by over 30 regulatory agencies around the world.

Annu Uppal
Director, Scientific Affairs
United States Pharmacopeia

Dr. Annu Uppal currently works as Director and Head of Scientific Affairs at USP. She is leading USP's Knowledge Hub initiative for Multi-Attribute Method, scientific engagement activities, and external collaborations. Before joining USP, she worked as a technical global lead for characterization and quantification of large biologics at SCIEX. She has experience in physiochemical characterization and impurity profiling of monoclonal atibodies, peptides and other protein biotherapeutics. Her areas of interest are glycosylation analysis, MAM, native mode, and host cell protein analysis. She received her Ph.D. in Biotechnology from Aligarh Muslim University. Dr. Annu is the author of more than 30 research papers and book chapters in peer-reviewed journals. She is also an approved faculty member for the USP biologics education program on method development and validation for biotherapeutics.

Register Free: https://www.biopharminternational.com/bp_w/multi-attribute