Many vaccines are unstable at room temperature and lose their efficacy over time. The higher the temperature, the faster this degradation occurs. Therefore most vaccines are produced, transported and stored under refrigerated or frozen conditions, adding significantly to their cost and to waste due to temperature control problems. Thermal stabilization is the process of formulating a product to withstand higher temperatures without degradation.
The World Health Organization (WHO) reports that 50% of all vaccines around the world are wasted due to thermostability issues. Elimination of the cold chain would facilitate the use of these vaccines in the lesser developed parts of the world. From the biodefense perspective, ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency settings. Subsequent savings from the elimination of cold chain costs would also increase the profitability of vaccine products.
Learn more about thermal stabilization
How is thermal stabilization achieved?
Protein degradation generally occurs due to the presence of water, enhancing chemical reactions which degrade the protein. Lyophilization (also known as freeze-drying) is a well-known method to remove the water from a protein mixture without degrading the protein. Unfortunately, lyophilization with aluminum has been known to enhance particulate formation, making the product less efficacious.
The ThermoVax® process uses additional components to aid in the suspension of the aluminum –protein mixture preventing particulate formation and enabling alum-adjuvanted vaccines to be lyophilized.
More details on thermal stabilization can be found in our Reference Literature.
How effective is thermal stabilization?
The ThermoVax® technology has been incorporated into Soligenix’s ricin toxin vaccine program (RiVax®). The RiVax when formulated as a liquid is very unstable, while the thermostabilized formulation retains potency even after storage for 12 months at 40°C (104°F).