Westin Miyako Kyoto,
Kyoto, Japan
Meet Sartorius at BPI Asia 2020
Vitis us at Booth 11 or Attend our Featured Presentation
About Sartorius Stedim Biotech
The Foundations for Single-Use Manufacturing.
Redefined from A-Z.
In the past, biopharma companies were struggling with various risk factors which kept them from implementing single-use systems.
With our solid single-use foundation for biomanufacturing processes we are solving all of these challenges simultaneously. Our fully integrated single-use platform connects an exclusive approach in biocompatibility, state-of-the-art integrity control and testing as well as a unique automation platform and supply network.
This strategy proves flexibility and acceleration which leads of a cost-effective process that ensures the quality of your biologics and enhances patient safety.
Featured Presentation
28 February, from 12:00 to 12:30
The Fate of Leachables: Development of Advanced Models to Predict Process Related Leachables
The implementation and use of single-use system (SUS) in bio-pharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond “simple” extractables measurement.
The author will develop and apply methods to predict extractables and leachables. It will be discussed that only an adequate physical and chemical understanding allows a correct scaling and combination of extractables data for the numerous devices and assemblies provided to the market. And it will be show how a mechanistic modelling, which combines sources and sinks of leachables appropriately can be used in risk assessments to quantitatively predict leachables along a process chain, in particular in intensified and continuous bio-pharmaceutical manufacturing.
Presenter: Armin Hauk, Principal Scientist at Sartorius-Stedim Biotech
