Many vaccines and next-generation viral-based therapeutics are thermally fragile, requiring storage temperatures of minus 50°C or below. Thermally fragile biologics need an extensive cold- or cryo-chain throughout manufacturing, distribution and storage to maintain efficacy. Cold chains are expensive but if the biologics are not stored and transported within the correct temperature range, this can result in loss of efficacy.

Even in industrialised countries, reliably maintaining cold chains can be difficult. A recent US Department of Health and Human Services report showed 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 iosBio’s patented technology for the thermo-stabilisation of viruses, vaccines and proteins. The technology has been successfully applied to several biopharmaceuticals and other temperature-sensitive 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. These small molecules are commonly found in natural diets, nutraceuticals and pharmaceuticals or are designated as generally recognised as safe (GRAS) by the US Food and Drug Administration (FDA). THERM-SB is entirely protein-free and of non-animal derived origin.

The THERM-SB technology works by displacing water from the hydration shell of the viral capsid, replacing the electrostatic interactions but ensuring that the viral capsids maintain the correct conformation to remain infectious.

 

THERM-SB: virus stabilisation technology

  • Thermal stabilisation: stable from +4°C to +37°C for two to three years in liquid and lyophilisation friendly formulation
  • Effective on all viruses: including vaccines, gene therapy vectors and oncolytic viruses
  • Simple, scalable and safe: low molecular weight small molecules, designated GRAS or already used in nutraceuticals/pharmaceuticals.
  • Compatible with existing downstream processing: with a low cost of goods sold (COGS)
  • Alum stabilisation: allows alum to be lyophilised, rehydrated, freeze-thawed and thermally protected with no aggregation or precipitation
  • Effects are independent of viral concentration: working equally well on low and high concentrations of virus

Thermal stability shown over a period of months

Excipients being mixed with virus to produce final liquid or freeze-dried vial

Dry powder TMG…