Stabilitech’s THERM-SB technology allows the stable storage of vaccines and viruses at ambient temperature
Many vaccines and next generation viral-based biotherapeutics are thermally fragile and need to be frozen at minus 50°C or below. They need an extensive cold-chain throughout manufacturing, distribution and storage at healthcare sites to maintain efficacy. Cold chains are expensive and risk the loss of vaccines and expensive biotherapeutics, especially where transport infrastructure is poor and can cause extreme temperature excursions. Even in industrialised countries reliably maintaining cold chains can be difficult, as demonstrated by a US Dept of Health and Human Services report showing vaccines regularly being subjected to inappropriate temperatures for 2.5 hours per week at 76% of the sites audited. In these circumstances, the rate of losses for fragile viruses would result in significantly reduced efficacy for vaccines and viral-vectored biotherapeutics.
Therm-SB is Stabilitech’s patented technology for the thermo-stabilization of viruses, vaccines and proteins. It has been applied successfully to a number of biopharmaceuticals and other temperature labile biological materials. Therm-SB is a formulation of simple sugars and non-toxic small molecules in discrete concentrations and ratios that are mixed with the vaccine during the fill-finish process. The small molecules are commonly found in a natural diet, nutraceuticals, pharmaceuticals and/or designated GRAS by the FDA. Therm-SB is entirely protein-free and of non-animal derived origin. Stabilitech believe Therm-SB displaces water from the hydration shell replacing their electrostatic interactions. When water is removed the viral capsids are able to maintain the correct conformation and remain infectious.
Therm-SB: virus stabilization
- Thermal stabilization: stable from +4C to +37C for 2-3 years, liquid and lyophilisation friendly formulation
- Effective on all viruses: vaccines, gene therapy vectors, oncolytic viruses
- Simple, Scalable, Safe: low Mw small molecules, designated GRAS, used in nutraceuticals/pharmaceuticals. Fits with existing downstream processing. Low COG
- Alum stabilization: allows alum to be lyophilized, rehydrated, freeze-thawed and thermal protection with no aggregation/precipitation
- Effects independent of viral concentration: works equally well on low concentrations of virus