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Predicting the Long-Term Stability of Biologics

Analysis of Formulation-Dependent Colloidal and Conformational Stability of Monoclonal Antibodies

Franziska Söltl, Jonathan Derix, Patrick Garidel, Michaela Blech, Dennis Breitsprecher

Relation between conformational and colloidal stability of antibodies

Schematic representation of the backreflection principle to detect protein aggregation

Conformational stability and aggregation of a mAb under different buffer conditions

The growing number of biological drugs such as monoclonal antibodies (mAbs), as well as the wealth of heterogeneity between mAb variants requires a thorough development process to maximize mAbs compliance with regulation. Therefore, biophysical analytical methods are required already at early stages of the development process to guide and streamline further antibody processing and to predict antibody developability. In this case study, we demonstrate how the Prometheus NT.48 can be used to predict long-term mAb stability in a formulation screen by simultaneous quantification of both, conformational and colloidal stability of biologicals in thermal gradients.

Facts, background information, dossiers
  • long-term stability
  • conformational stability
  • colloidal stability
  • biologicals
  • aggregation
  • backreflection
  • protein aggregation
  • protein aggregate c…
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