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  4. Nondestructive Analytics for Biologics and Continuous Biomanufacturing - 03/19/2019 - 03/19/2019
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Webcast | Virtual

Event Title
Nondestructive Analytics for Biologics and Continuous Biomanufacturing
March 19, 2019

Scheduled
Date:
March 19, 2019
University of Maryland CERSI

Tuesday, March 19, 2019


Presented by:
Picture of Brue Yu, Ph.D.


Bruce Yu, Ph.D
Professor, Pharmaceutical Sciences
Director, Bio- and Nano-Technology Center
University of Maryland School of Pharmacy

About the Presentation

Water is the dominant component of most pharmaceutical solutions. Water proton NMR (wNMR), a nondestructive analytical technology, can be used to quantitatively inspect drug and biological products without compromising their integrity. wNMR is also being developed as noninvasive in-line process analytical technology for uninterrupted continuous biomanufacturing. It has the potential to quantitatively inspect every vial in a batch both before and after product release, as well as at the point-of-care.

In this lecture, Dr. Yu provided a background on wNMR, discussed examples of applying wNMR to inspect FDA-approved biologics (vaccines, vaccine adjuvants, and a therapeutic protein) and a non-biologic complex drug (Ferrlecit), and described how wNMR can be used to improve continuous biomanufacturing.

About the Presenter

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. He received the 2004 Kimmel Scholar Award and the 2005 US Presidential Early Career Awards for Scientists and Engineers. He received a Ph.D. in molecular biophysics from Johns Hopkins University.

Recording

https://collaboration.fda.gov/p2wbcgo2c6qz/

 

 

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