Bruce Yu, PhD, University of Maryland
Dr. Bruce Yu is a Professor of Pharmaceutical Sciences, and Director of the Bio- and Nano-Technology Center at the University of Maryland School of Pharmacy. Dr. Yu has conducted research on proteins, imaging agents and biomaterials. His current focus is on noninvasive analytics for biologics and complex drug products, for manufacturing and quality control. He received the 2004 Kimmel Scholar Award and the 2005 US Presidential Early Career Awards for Scientists and Engineers. He holds a Ph.D. in molecular biophysics from the Johns Hopkins University.
All vials are not the same: potential role of vaccine quality in vaccine adverse reactions
Pharmaceutical manufacturing is not very precise. It is unrealistic to expect zero defect rate for a drug product due to a combination of manufacturing and handling variabilities. However, current pharmaceutical QC is conducted at the batch-level with no data on released vials. The lack of vial-level QC data makes it very challenging to prevent and investigate the possibility that a few defective vials may cause adverse reactions to vaccines and drugs. A potential pathway to evolve from batch-level to vial-level QC is discussed.