Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

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 Min 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.

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.

Instructor: Nanda Subbarao

Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases. She has extensive expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee.