Pharmaceuticals 2012 - Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

This training on Forced Degradation study on a Protein Therapeutic will discuss on the Forced Degradation Studies required for Well Characterized Protein Therapeutic products and how to leverage forced degradation results to design stability studies for Drug substances.

Why Should You Attend:

A well designed Program for Protein Therapeutic Lot Release and Stability, 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. While retained samples of conventional drugs can be re-tested at later dates by newly implemented methods, such re-testing of WCP samples is usually less successful. A well designed analytical program will therefore minimize the need for repeating costly stability studies as a result of feedback from regulatory agencies.

Areas Covered in the Seminar:
- The goal of Forced Deg studies .
- Stress conditions for Forced deg studies.
- Degradants generated by these stress conditions.
- Methods required to study these degradant.
- Leveraging forced deg results to design stability studies.
- Using forced deg results in specification setting.
- Common pitfalls in Biologics Stability Studies.
- Types of deficiency letter comments.