Event Detail
Comprehensive Forced Degradation Studies to Validate Stability–Indicating Methods for Biotechnology Products
March 15, 2010
- Live Webinar CANADA
BenAstrum
Biotech - Live Web Training Course Monday, March 15, 2010 (1:20 p.m. – 3:45 p.m. EST) (12:20 p.m. – 2:45 p.m. CST) (10:20 a.m. – 12:45 p.m. PST) Instructor: Nadine M. Ritter, PhD Discussion Points: Defining a Biotechnology Stability-Indicating Profile * Orthogonal test methods for various types of biotechnology products * Potential degradation pathways for proteins * Method validation parameters for QC release and stability methods Outline of Forced Degradation Studies * Overview of forced degradation experiment matrix * Execution of physical and chemical conditions * Review and analysis of study data to validate stability-indicating methods