Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals 2018

Topics

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

Who should Attend

• R&D laboratory personnel
• Stability department personnel
• QC laboratory personnel and management
• R&D laboratory supervisors and management
• Regulatory affairs personnel
• Protein formulation group personnel and management
• Regulatory affairs management