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Midwest Discussion Group June 2017
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Thursday, June 8, 2017

University Center of Lake County
1200 University Center Drive
Grayslake, IL 60030

Challenges or Special Considerations When Developing ADCs and Bispecifics


The CASSS Midwest Discussion Group is committed to bringing job-relevant educational and regulatory trends  for biopharmaceuticals to CASSS members through meeting programs. The June discussion group will focus on understanding Antibody Drug Conjugates (ADCs) and Bispecific Antibodies 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 both industry and the FDA. The program will also provide a platform for networking with 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 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. Process development experiences and challenges in the development of Bispecifics mAbs.
     d. Control strategy considerations for Bispecific mAbs and ADCs. 


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Featured Members
Michelle R. Frazier, Coherus BiosciencesCASSS Associate Director Michelle Frazier is VP for Regulatory Affairs with Coherus.

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