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GEN Webinars: January 01, 1990

Win More Biologics Development Battles with Early Stability Analysis

<p> Biophysical and chemical properties are critical factors that can dictate success or failure in the development of therapeutic antibodies. These attributes and all the functional characteristics of antibodies depend on amino acid sequence, post-translational modifications, and the solution environment. Early quality control and risk assessment of biophysical parameters help prevent failure in later stages of antibody development. An early-stage developability workflow was designed to set stage gate for molecules progressing to late-stage development. Application of the Uncle platform in antibody selection will be presented in this webinar. Stability analysis of engineered antibody variants was evaluated using Intrinsic Fluorescence Conformational Stability (T<sub>m</sub>) and Colloidal Stability (T<sub>agg</sub>). B<sub>22</sub>/k<sub>D</sub> parameters for monoclonal antibodies (mAbs) in solution were determined and validated by Small-Angle-X ray-scattering (SAXS). Quantitative correlation between T<sub>agg</sub> and particle size for mAbs was observed in this study.</p> <h3> Who Should Attend</h3> <ul> <li> Researchers developing monoclonal antibodies</li> <li> Drug discovery scientists</li> <li> Investigators interested in biologic stability</li> <li> Biochemists</li> <li> QC/QA scientists</li> </ul> <h3> You Will Learn</h3> <ul> <li> How to use T<sub>m</sub> and T<sub>agg</sub> measurements to evaluate the stability of engineered antibodies</li> <li> How the aggregation propensity parameters B<sub>22</sub> and k<sub>D</sub> can help further evaluate antibody variants</li> <li> How the Uncle platform can collect multiple measurements earlier, with less sample</li> </ul>