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CASSS Northern California Regional Forum Fall 2017
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Thursday, October 12, 2017

South San Francisco Conference Center
255 South Airport Boulevard
South San Francisco, CA 94080

 
  

 

 



Challenges or Special Considerations When Developing ADC’s and Bispecifics
 
Co-Chairs:  Vinaya Kapoor, Johnson and Johnson and Trevor Swartz, Genentech, a Member of the Roche Group

The CASSS Northern California Regional Forum is committed to bringing job-relevant education and regulatory trends for biopharmaceuticals to CASSS members through meeting programs. The October forum will focus on understanding Antibody Drug Conjugates (ADCs) and Bispecific Monoclonal Antibodies (mAbs) and the unique challenges these molecules present during product development. The discussion will include content from other regional, national or international forums organized by CASSS and speakers from industry and FDA. The program will also provide a platform for networking with both peers and regulatory authorities.

 

Learning Objectives: 

1. Discuss current CMC development FDA challenges, trends and expectations for ADCs and Bispecifics with industry and FDA colleagues.

2. Learn industry best practices in overcoming development and regulatory challenges for ADCs and Bispecific mAbs.   Key areas of focus will include:

a.    Process development experiences and challenges in the conjugation chemistry for ADCs.

b.    Formulation, stability, and analytical method / characterization challenges with ADCs.

c.    Analytical method / characterization challenges in the development of Bispecifics Antibodies

d.    Control strategy considerations for Bispecific antibodies and ADCs.

 


  

About the Discussion Groups:
CASSS began as a local, non-profit chromatography discussion group in the San Francisco Bay Area. Although the society's offerings have now grown to include multiple North American and international scientific symposia and its members span the globe, CASSS still provides local educational and networking opportunities for scientists in regions across the US. The CASSS Regional Forums are your opportunity to meet others who understand what you do, in an informal setting, and exchange new ideas.







 

 

 

 
 
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