Webinar Description:

Cell and gene therapies (CGT) promise to become revolutionary curative treatments, yet realization of this potential requires advances in biomolecular understanding to be on par with quality standards of today’s state-of-the art treatments (e.g. monoclonal antibodies).

Molecular complexity is magnified significantly in CGT, as is the need to pursue adaptation, targeted innovation, and implementation of high-resolution analytical measurement approaches to further the understanding and development of these novel modalities.

This talk will describe translation of principles of the multi-attribute mass spectrometry method (MAM) toward identification and control of quality attributes of emerging therapeutic modalities.

Learning Objectives:

• Gain insight about the unique analytical challenges presented by next generation biotherapeutics
• Learn how multi-attribute mass spectrometry can address key biopharma industry requirements
• Explore how the principles of MAM, including attribute control and new peak detection, can support next generation biotherapeutic development

Speaker:

John Schiel, PhD
Research Chemist
National Institute of Standards and Technology (NIST), Institute of Bioscience and Biotechnology Research, Rockville, Maryland, United States

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.

About Genedata:

As a comprehensive software solution for transforming raw data from any mass spectrometry instrument into insights, Genedata Expressionist offers built-in functionalities that serve all applications in biopharma mass spectrometry in a single enterprise platform. Custom-built workflows address specific data processing, analysis, and reporting needs and enable harmonization and standardization between and across organizations. Complete automation, unbiased data interrogation with best-in-class algorithms and cutting-edge statistics, and intuitive visualizations deliver high-quality results with significant time and cost savings. Integrated data and project management enables organizations to streamline methods and efficiently manage data, results, and reports.

Cost: No Cost!