Cell Culture Media Solution Preparation
In-process characterization and tech transfer to CMO
プログラム概要
- Real-time monitoring to enable the understanding of the process
- Leveraging technology to better support tech transfer process
In-line monitoring platform was employed to evaluate the media dissolution process at development scale. The key factors, i.e., pH, temperature, particle size, etc., were real-time monitored to better understand the potential impact that would affect hydration and/or lead the precipitation.
We share a case study regarding incomplete dissolution of media solutions during technology transfer to CMO. It shows the importance of using scale down model for screening factors that could impact the media solution preparation process.
About the Presenter
Yue Hu, Ph.D.
Senior Scientist, Material Sciences | Biotherapeutics Development & Supply | Janssen R&D, LLC
Yue Hu is a senior scientist from Material Sciences team in Janssen R&D. She is responsible for performing material qualification of chemically defined media and upstream raw material utilized in multiple R&D and Supply Chain pharmaceutical product portfolio at Janssen. She also serves as Scientific Integrator in CMC team on multiply clinical programs. Prior to joining Janssen, she conducted her post-doc research at Cornell university in genetic material and obtained her Ph.D. degree at Stevens Institute of Technology in material engineering, focusing on the area of nano photonics.
