THE NEED FOR THERMOSTABILIZATION
Many vaccines and proteins require to be manufactured, shipped and stored in refrigerated containers. Some of the next generation vaccines need to be frozen at -50C or below and once thawed for use have to be administered promptly. For the first world, this has significant cost implications. For the developing world, in addition to cost, it often means that vaccines are rendered useless due to temperature excursions.
Many new vaccines and biopharmaceuticals never move past the development stage as they are too thermally unstable.
The need for providing thermally stable vaccines has been documented by NGOs:
THERM-SB – VIRAL VACCINE AND PROTEIN STABILITY PLATFORM
Stabilitech has developed Therm-SB, a proprietary technology for the thermo-stabilization of vaccines and proteins. The same technology has successfully been applied to a number of biopharmaceuticals and other temperature labile biological materials.
We have extensive data showing successful stabilization, in the dry state, of a variety of thermally sensitive viral vaccines and biopharmaceuticals surviving heat challenges for extended periods at temperatures of 37˚C and above. Therm-SB can give protection against both heat and freeze damage, as demonstrated by temperature cycling from ‑20°C to +37°C, which mimics the temperature fluctuations that often occur during transport and distribution of vaccines and biopharmaceuticals.
In addition, the thermally stable products have enabled additional technologies (antigen sparing using the AntiSpare technology; AccelImmune – accelerated immunity) to be developed which may have a dramatic impact in their fields.
Therm-SB has the potential to remove the stringent reliance upon cold chain transport which is costly, complicated to manage and non-existent in certain field conditions. Its subsidiary technologies may have significant input into reducing the cost of vaccines by reducing manufacturing costs, enable self-administration and eliminate wastage of heat exposed vaccines.
- Removes the need for cold chain / refrigerated storage
- Removes risk of freeze damage
- Protects against temperature fluctuations (e.g. -20°C to +37°C)
- Enables long-term storage of thermally sensitive vaccines and biopharmaceuticals
- Prevents inadvertent administration of heat-inactivated vaccine
- Facilitates stockpiling eg for pandemic influenza and biodefence vaccines
- Provides competitive advantage through product differentiation and enabling patent extension
- Viruses: live, enveloped, non-enveloped & inactivated
- Vaccines: viral, subunit & adjuvanted
- Biopharmaceuticals: peptides, proteins eg antibodies, growth factors, enzymes etc
SAFE, ROBUST, SIMPLE
- Excipients have all previously been used in clinical settings
- Easily be integrated into existing cGMP manufacturing processes
- Uses standard manufacturing equipment
- Low Cost of Goods (COGS)
FAST FEASIBILITY STUDIES
The experience that Stabilitech has built up with a range of different viruses and proteins enables new projects to start quickly and efficiently. Each project will move though a number of 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 7 days, depending on the nature of the agent being studied and the goals of the feasibility study.
Stabilitech has a number of long running, real-time stability studies that have demonstrated the ability of the formulations to maintain viability of viruses for time-periods that are required by industry partners for commercial product shelf life. In addition, recent data has also been generated illustrating that an 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.
The process has been designed to seamlessly integrate with current manufacturing processes using standard equipment. The final formulation can either be kept as a liquid or can be freeze-dried and stored as a lyophilized product with reconstitution using water for injection.
COST AND REGULATORY
Cost and regulatory acceptance have been a major consideration when developing Stabilitech formulations. All the excipients are available either as existing pharmaceutical excipients 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 and may in some cases lessen the cost per dose.
A patent portfolio has been established and new patents are filed based on the on-going research. The patents are filed via the Patent Cooperation Treaty (PCT) system and individual countries are selected in due course.