Talk 1: Forced Degradation Studies to Demonstrate Formulation Limits
Olivier Brass, Formulation Development Unit Head, Sanofi Pasteur, France
Talk 2: Determination of the forced degradation conditions for generating antibody and ADC samples with desired degradation levels
Forced degradation is used for multiple purposes during drug development, including the evaluation of the stability indicating nature of the analytical methods. The typical stress conditions applied to protein therapeutics are exposures to low and high pH, UV and white fluorescent light, heat and oxidizing agents. To achieve the desired degradation level, the stressing conditions need to be established. The presentation will discuss the methodologies for forced degradation applied to an antibody and its conjugate (ADC).
Paul Weisbach, Scientist I, Analytical Pharmaceutical Sciences, Immunogen, USA