July 21, 2021 – MSDG Meeting

Abstract:  Characterization of mAbs has evolved during the past 30 years to include a toolbox of measurements to elucidate identity, quality, and stability. Molecular complexity is magnified with gene therapies, as is the need to pursue adaptation of high-resolution analytical measurement approaches to further the understanding and development of these novel modalities. This talk will describe the principles of the multi-attribute mass spectrometry method (MAM) as applied to mAbs and its evolution toward identification and control of viral vector quality attributes.

Bio:  Dr. Schiel received his BS (2004) and Ph.D. (2009) in chemistry from the University of Nebraska-Lincoln, and is currently a research chemist in the NIST Biomolecular Measurement Division. Dr. Schiel coordinates the development of Reference Materials that support the biomanufacturing industry, including the recombinant IgG1κ NIST monoclonal antibody Reference Material 8671 (NISTmAB). He also leads an analytical research team developing innovative approaches toward production/characterization of next generation biotherapeutics (e.g. viral vectors, cell therapy products, and vaccines) and de-risking of innovative technologies for lifecycle appropriate implementation and regulatory assimilation. He is an author of over 30 publications, an editor of the ACS book series “State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization”, and recipient of numerous Awards including the Arthur S. Flemming Award, Department of Commerce Gold Medal, ACS Division of Analytical Chemistry Fellowship, Bioanalysis Young Investigator Award, and UNL Early Achiever Award.

Abstract:  Mass spectrometry plays a vital role in the measurement and characterization of synthetic DNA and RNA oligonucleotides (oligos), which are used widely in molecular biology and in the development of therapeutics. This webinar will highlight (1) the quantitative analysis of oligos, both by QQQ and HRAM technologies, to achieve the best combination of sensitivity and speed, (2) impurities determinations using HRAM, multiple analysis techniques, and purpose-built software, and (3) high-throughput methods that enable the acquisition, analysis, and purity review of over 5,000 samples a day. Join us to push the speed, sensitivity, and dynamic range of oligo measurements to new heights.