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CMC Strategy Forum January 2020
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Control of Excipients and HCPs: Impact on Visible Particles
Forum Co-chairs:
   
 Taro Fujimori, AbbVie Bioresearch Center
      Jason Starkey, Pfizer, Inc. 


This Forum will: 

     ~Discuss approaches and best practices on the assessment of visible particles; and 
     ~Discuss overall control around excipient surfactants from raw material, manufacturing controls to final product release and stability testing. 


Leveraging Stability Studies to Support Process / Product Development 
Forum Co-chairs:
     Barry Cherney, Amgen Inc. 
     Timothy Schofield, CMC Sciences, LLC 

The following aspects will be incorporated into this Forum:  

   
~Focused discussion on when, how to conduct these studies and interpretation of results for comparability; 
     ~Stability studies for DS and DP presentations to enable commercial shelf life, evolving regulatory trends and how stability studies are included to demonstrate 
       comparability; and 
     ~Discuss methodologies for forced degradation and the utility of forced degradation studies in CMC development. 

           

 To visit the WCBP 2020 meeting homepage, click here



 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 info@casss.org

 


To register for this meeting, click here

To visit the CMC Strategy Forum meeting homepage, click here

To register for this meeting, click here

To visit the CMC Strategy Forum meeting homepage, click here

 
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