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CMC Forum January 2020: Speaker Presentations
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Below you will find links to presentations from the CMC Strategy Forum January 2020. Presentations are organized by forum track.  If you have questions regarding the links, please contact Alissa Doyle at

The Impact of Excipients and HCPs on the Formation of Particles in Biologics
Analytics for Particle Detection in Biologics and Excipient Degradation Mechanisms 
Felix Nikels Slides
Mario Hubert Slides
Lihua Huang Slides
Christian Schöneich Slides
Mitigation Strategies of Particle Formation and Regulatory Perspectives  
Ashutosh Rao Slides  
Kishore Ravuri Slides 
 Atanas Koulov Slides
Paula Russell Slides 
 Summary Slides

 Leveraging Stability Studies to Support Product Licensure and

Lifecycle Management

Regulatory Expectations and Best Practices for Stability Studies Supporting Comparability Throughout a Biological Product’s Lifecycle 
Noel Rieder Slides
 Richard Burdick Slides 
Dean Smith Slides
 Bazarragchaa Damdinsuren Slides
Leveraging Supportive Stability Studies to Enhance Product Knowledge and
Support Marketing Applications 
 Philip Krause Slides
Elisabeth Krug Slides
Amy St. Charles Slides
 Nolan Polson Slides
 Summary Slides

The views and opinions expressed in these PPT slides are those of the individual presenter and should not be attributed to CASSS, An International Separation Science Society, its directors, officers, employees, volunteers, members chapters, councils or affiliates, or any organization with which the presenter is employed or affiliated.

These PPT slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries.  Used by permission.  All rights reserved.  CASSS and CASSS logo are registered trademarks.  All other trademarks are the property of their respective owners.


more Calendar

9/14/2020 » 9/17/2020
Mass Spec 2020

9/28/2020 » 10/1/2020
CE Pharm 2020

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