THERM-SB OVERVIEW

All Stabilitech’s technologies and products are based on the Therm-SB platform technology:

  • Antigen-sparing
  • Accelerated immunity
  • Thermal stability of vaccines
  • Thermal stability of viruses used in biopharmaceuticals
  • Minimising loss in vaccine production
  • Reduced manufacturing costs
  • Increased manufacturing yield

Therm-SB enables vaccines to be stored in liquid or lyophilized state.

STABILITY RESULTS

The time and temperature stability profiles of processed products all show remarkable levels of enhancement.

As an example, a leading varicella vaccine must be stored long term between ‑50°C and ‑15°C and can only be stored for up to 72 hours continuously at between 2°C and 8°C.  The Stabilitech varicella vaccine can be stored at 25°C for more than 60 days without loss of infectivity.

EXCIPIENTS

Therm-SB is a formulation of simple sugars and non-toxic chemicals in discrete concentrations and ratios that are mixed with the vaccine during the fill-finish process.  The excipients are entirely protein-free and of non-animal derived origin.

METHOD OF ACTION

We believe that the formulants in Therm-SB displace 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.

REGULATORY

Products based on Therm-SB have a relatively straightforward route to human trials and most of the studies needed have already been completed.

TOXICOLOGY

The constituents of our formulations have all been shown to be nontoxic in several studies.  A full toxicology report is available on request.

MANUFACTURING

Therm-SB requires only small, minimally disruptive changes to the manufacturing process and only at the fill-finish stage.

Thermal stability shown over a period of months

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

Dry powder TMG…