Maura C. Kibbey

Biography

 Dr. Maura Kibbey is a Senior Scientific Liaison in the Biologics and Biotechnology (B&B) Department in the Global Science & Standards Division at USP. Maura's primary focus is to work with the General Chapter Expert Committee to develop documentary standards that support biopharmaceutical quality assessment. Maura also assists with development of B&B monographs. Before joining USP, Dr. Kibbey worked for several biotech and diagnostic companies in the Washington DC area as well as at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions (e.g.,ligand-binding methods with multiple technology platforms, immunogenicity assays, nucleic acid quantitation, transcription factor binding assays, receptor-ligand interactions, etc.).

Research Interest

  Design and Analysis of Biological Assays will be revised to include only critical elements, including: combination of independent assays, outlier determination, and calculation of confidence intervals. In addition to these chapter changes, USP Expert Committees continue to work to replace animal-based bioassays in compendia standards where possible