Date recorded: May 06 2020

In order to ensure efficient development of a protein therapeutic it is important that the drug is formulated, and then stored, in a manner that optimizes stability from the earliest stages of the process.

As this webinar suggests, making assumptions on the appropriate conditions of storage can lead to costly issues later in the workflow. Instead, an orthogonal approach to understanding stability
profiles during pre-clinical development of an antigen vaccine is presented.

RSV (Respiratory Syncytial Virus) infects nearly all children in temperate climates, occurring as a consistent winter epidemic. The virus infects ~ 60-70 million people each year, causing bronchiolitis
in 1-2 million of those. RSV epidemics are responsible for 160,000 deaths per year globally.

Size Exclusion Chromatography demonstrates an unexpected reduction in potency of RSV antigen (RSVA) batches stored at 4 °C compared with those stored at 25 °C, with CD and AUC data
suggesting a loss of tertiary structure and compaction of the antigen during refrigeration.

Differential Scanning Calorimetry (DSC), a highly sensitive and informative means of elucidating changes in structure and stability, indicates that refrigeration caused cold denaturation of the antigen, with a complete DSC thermodynamic analysis indicating that the antigen is optimally stable at 25-35 °C.

In summary, this webinar will demonstrate the central role of DSC, as part of a panel of biophysical methods, in generating information that can be used to minimize waste and refrigeration costs during both the development process and product life-cycle, and also inform the selection of storage-appropriate excipients during the post-clinical formulation process.