The NISTmAb and Related Biopharmaceutical Resources

Presented at: BioProcessing 2020
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Research Chemist, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology
    Biography
      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. He also leads an analytical research team developing innovative approaches toward production/characterization of next generation biotherapeutics, complex dataset integration and its impact on biosimilarity, structure-function correlations, 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 Department of Commerce Gold Medal, ACS Division of Analytical Chemistry Fellowship, Bioanalysis Young Investigator Award, and UNL Early Achiever Award.

    Abstract

    The NIST Biomanufacturing Program develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines.  Lifecycle appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators, an effort facilitated by widely available test metrics.  Biopharmaceutical quality materials, however, are often difficult to access and/or are protected by intellectual property rights.  The NISTmAb IgG1k is a NIST Reference Material (RM 8671) intended to fill that void. The NISTmAb embodies the quality and characteristics of a biopharmaceutical product, is widely available to the biopharmaceutical community, and is an open innovation tool for development and dissemination of results.  The utility of the NISTmAb as an industry-wide test metric to evaluate performance of emerging technologies, foster collaboration, and spur innovation will also be discussed.

    Learning Objectives:

    1. Familiarization with the NIST monoclonal antibody (NISTmAb) and its utility in advancing biopharmaceutical analytics

    2. Gain knowledge about the many applications of multi-attribute mass spectrometry methods and opportunities/challenges facing implementation into QC.


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