Fecha registrada: May 06 2020
How can selecting appropriate storage conditions at the pre-clinical stage increase the efficiency of vaccine development? This webinar demonstrates how differential scanning calorimetry (DSC) can play a role in generating information that can be used to minimize waste and refrigeration costs throughout a vaccine’s life-cycle, from development to distribution and storage. You will also see how DSC data can inform the selection of storage-appropriate excipients during the post-clinical formulation process.
Ensuring efficient development of a protein therapeutic requires that a drug is formulated and stored in a manner that optimizes stability from the earliest stages of the process.
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 required.
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 (SEC) demonstrates an unexpected reduction in the 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 causes cold denaturation of the antigen, with a complete DSC thermodynamic analysis indicating that the antigen is optimally stable at 25-35 °C.