Multi-Attribute Method
This webinar will provide an overview of the principles and practical guidance regarding the LC-MS-based peptide mapping approach of the multi-attribute method (MAM) for therapeutic proteins as described in USP General Chapter <1060> . Our panelists Sheila Mugabe from the USP and Ying Qing Yu from Waters will discuss considerations for system readiness as well as enhancements to the robustness for MAM workflows.
Key Learning Objectives
- Learn about USP<1060> Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins
- Explore considerations for system readiness
- Improve robustness in your MAM workflows
Who should attend
- Analytical scientists involved with the characterization or monitoring of therapeutic protein quality attributes
Presenter: Sheila Mugabe (Sr Scientist, US Pharmacopeia)
Sheila Mugabe is a Senior Scientist at U.S Pharmacopeial Convention where she supports analysis of biotherapeutic proteins and peptides using LC and LC/MS/MS based methods for product characterization, identification and stability monitoring. For more than 15 years she has worked in the industry supporting identification of posttranslational modifications using peptide mapping, glycan profiling, identification of product degradation pathways among other analysis. She is excited about the growing trend of the multi-attribute method, with its capabilities, opportunities and challenges. Before USP, Sheila worked at AstraZeneca, Novavax and MacroGenics. She is an Analytical Chemist by training and holds a Master of Science from Makerere University, Kampala, Uganda.
Presenter: Ying Qing Yu, Ph.D. (Director of the Biopharmaceutical Science and Evaluation, Waters Corporation)
Ying Qing is the Director of the Biopharmaceutical Science and Evaluation group at Waters Corporation. Before joining Waters Corporation in 2001, Ying Qing received her Ph.D. from the Analytical Chemistry Department at Purdue University, specialized in High Resolution Mass Spectrometry. Her area of expertise is on analytical method development for various Biotherapeutics using UPLC/QTOF MS platform, including sample preparations, LC-MS optimization, and development of application specific software tools. Ying Qing and her science team played key roles in commercialization of many impactful Biopharma products such as Glycoworks RapiFluor-MS N-Glycan kit, MassPrep standards, HDX-MS system, and various data processing software including Multi-Attribute Method (MAM).
Presenter: Moderated by: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)
Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.
