Reference Standards, Critical Reagents and Assay Controls – How to Manage and Case Studies

Co-Chairs: Qin Sheng, Eli Lilly and Company and Amy St. Charles, Pfizer, Inc.

Reference standards, critical reagents and assay controls play critical roles in calibrating and confirming the suitability of analytical methods used to assess quality attributes of biologics during characterization, comparability, lot release, and confirmation of stability.  In this session, we will explore strategies used to manufacture, characterize, control, and maintain reference standards, critical reagents and assay controls throughout a product’s life cycle.

The learning objectives for this forum are:
1. How to characterize reference standards and establish phase appropriate specifications
2. Potency assignment and bio-equivalence between batches
3. Stability monitoring and overall life-cycle management strategies
4. Novel technology in characterization of critical reagents (tentative bonus topic) 

About the Regional Forums:

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 utilizing prior knowledge for platform, an interactive panel discussion, a case study, peer-to-peer learning, and networking opportunities.

 

 

Want more information? Contact CASSS at 510-428-0740 or ambenz@casss.org