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.

Areas Covered in the Seminar:

• What is the purpose of a Forced degradation study?
• What are the conditions to be used during well characterized protein forced degradation study?
• How to test for the degradants?
• Design of a compliance wcp stability study based on the forced degradation results.
• Conduct of a biologics stability study.
• Common mistakes during forced degradation studies.

Who Will Benefit:

• Stability department personnel
• R&D Laboratory personnel
• R&D Laboratory Supervisors and Management
• QC Laboratory personnel and management