Industry experts from research, product development and the FDA will give their perspectives on their experiences and discuss creative problem solving for protein therapeutic development, scale-up and production. The FDA's efforts to address immunogenicity and protein aggregation challenges in bioprocessing of clinical product will be described.



Objectives:

Gain understanding of the role of protein aggregates in immunogenicity.

Discuss the appropriate use of analytical methods to detect and quantify aggregates.

Discuss the process methods available to address aggregates.