Why is thermostability important?
Many vaccines and proteins are highly unstable at ambient temperatures and require refrigeration during manufacturing, shipping and storage. For next-generation vaccines, temperatures often need to be maintained at -50°C or below and, once thawed, the vaccines must be administered promptly. This has significant cost implications for all markets, but in developing countries, where temperature control is more challenging, this often means that vaccines are rendered useless due to temperature excursions.
Added to this, many new vaccines and biopharmaceuticals simply never move past the development stage as they are too thermally unstable.
The need for providing thermally stable vaccines has been well documented by non-governmental organisations (NGOs):
THERM-SB™ – VIRAL VACCINE AND PROTEIN STABILITY PLATFORM
Stabilitech has developed THERM-SB™, proprietary technology for the thermo-stabilisation of vaccines and proteins, as well as temperature labile biological materials.
We have extensive data showing successful stabilisation, in a dry state at extended temperatures of 37˚C and above, of a variety of thermally sensitive viral vaccines and biopharmaceuticals. THERM-SB can give protection against both heat and freeze damage, as demonstrated by temperature cycling from ‑20°C to +37°C, mimicking the temperature fluctuations that often occur during transport and distribution of vaccines and biopharmaceuticals.
THERM-SB: removing reliance on the costly cold chain
Cold chain transport is costly, complicated to manage and non-existent in certain field conditions. By using thermostable vaccines, the cost of production is reduced, self-administration through oral vaccines is possible and wastage is reduced.
- Removes the need for cold chain/refrigerated storage
- Eliminates risk of freeze damage
- Protects against temperature fluctuations in the range -20°C to +37°C
- Enables long-term storage of thermally sensitive vaccines and biopharmaceuticals
- Prevents inadvertent administration of a heat-inactivated vaccine
- Facilitates stockpiling for pandemic and biodefence vaccines
- Provides a competitive advantage through product differentiation and patent extension
THERM-SB is applicable for:
- Viruses: live, enveloped, non-enveloped and inactivated
- Vaccines: viral, subunit and adjuvanted
- Biopharmaceuticals: peptides and proteins antibodies, including growth factors and enzymes
THERM-SB: safe, robust and simple
- Excipients have all previously been used in clinical settings
- Easily integrated into existing current good manufacturing practices (cGMP)
- Uses standard manufacturing equipment
- Facilitates low cost of goods (COGS)
Fast feasibility studies
We’ve demonstrated THERM-SB’s effectiveness with a wide range of viruses and proteins, enabling new projects to start quickly and efficiently. Each project will move through several optimisation stages where the effect of the different excipients is observed using short, high-temperature stability studies. The high-temperature studies are usually carried out at +56°C, +40°C or +37°C, for seven days, depending on the nature of the agent being studied and the goals of the feasibility study.
We have several long-running, real-time stability studies that show the viability of our formulations to maintain viruses for the time-periods required by industry partners for commercial product shelf life. In addition, recent data also shows that an immunoglobulin G (IgG) response is mounted after oral administration of test products and that expression of products in the peripheral circulation can be obtained following oral administration.
Our technology has been designed to integrate seamlessly with current manufacturing processes using standard equipment. The final formulation can either be kept as a liquid or freeze-dried and stored as a lyophilised product with reconstitution using water for injection.
Cost and regulatory acceptance
Cost and regulatory acceptance have been major considerations when developing our formulations. Our excipients are either already in use or can be produced to the relevant manufacturing standard by existing excipient manufacturers. The cost per dose of vaccine is low and will not add significantly to the final cost of the product. In fact, in some cases, it may reduce the cost.
We have established a new patent portfolio and new patents are filed based on the on-going research. Each patent is filed via the Patent Cooperation Treaty (PCT) system and individual countries are selected in due course.