Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
Midwest Regional Forum October 2017
Share |
 

Thursday, October 5, 2017

Eli Lilly and Company Campus, Indianapolis, IN 

 





Managing Process-related Impurities in Biological Products


Thank you to everyone who participated in the Midwest Regional Forum! 
Don't miss our next program: "Clinical Relevance for Setting Commercial Specifications"
Spring 2018 in St. Louis, MO!

The CASSS Midwest Regional Forum is committed to bringing job-relevant education to the local biopharmaceutical and biotechnology community. These programs are dedicated to facilitating the sharing of information and best practices in order to advance scientific knowledge across industry, academia, and regulatory agencies. This full day program will feature presentations on managing process related impurities in biological products, an interactive panel discussion, roundtable discussions, and opportunities to network with peers.

 

 Learning Objectives: 

1. Discuss CMC aspects of control strategy development for process related impurities, including FDA challenges, trends and expectations with industry and FDA colleagues.

2. Learn industry best practices in overcoming development and regulatory challenges for process related impurities. Key areas of focus will include:
     a. Host Cell proteins and DNA
     b. Process removal of biologic impurities
     c. Analytical method considerations for process-related impurities
     d. Control strategy considerations including appropriate limits and clinical experience

   

Want more information? Check out the "More in this Section" dropdown box at the top of the page!
Or contact CASSS at 510-428-0740 or alingel@casss.org

 


  

 

 

 
 
 
more Calendar

12/4/2017 » 12/5/2017
CMC Strategy Forum Japan 2017

Featured Members
Jamie Moore, Genentech, a Member of the Roche GroupVisit the CASSS News page to get to know Jamie Moore!

Membership Software Powered by YourMembership  ::  Legal