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.

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.

Who Will Benefit:

This course is intended to provide training on how to evaluate compendial methods in order to comply with USP

• R&D Laboratory personnel
• R&D Laboratory Supervisors and Management
• QC Laboratory personnel and management
• Protein Formulation Group personnel and Management
• Regulatory Affairs personnel
• Regulatory Affairs Management
• Project Managers responsible for CMC sections