Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

This 90-minute training will provide you with an overview of a forced degradation study on a protein therapeutic and help you interpret and leverage the results to design stability studies required for registration of the BLA.

Why Should You Attend:

A comprehensive forced degradation study is essential for design of an analytical program which when implemented right from the initial stages of a project will result in right-first-time CMC data package and therefore lead to cost savings in terms of analytical lab and regulatory department resource requirements. The forced degradation results must be incorporated in the design of the compliant stability program which is essential for the success of a well characterized protein product.

This 90 minute session is designed to provide the attendee with an overview of a forced degradation study on a protein therapeutic and to interpret and leverage the results to design the stability studies required for registration of the BLA. The speaker will address the stress conditions typically used to study the tendency of the protein to undergo degradation along with the analytical methods required for the study. Forced degradation study data must be utilized during the design of the stability program. We will discuss how you can leverage the forced degradation results to design stability studies for the drug substance and drug product. The regulatory requirements for such studies will be addressed.