Fuji Tilburg Research Laboratories

Vaccine- and drug stabiliser

Traditional gelatines are commonly used as stabilisers for vaccines. However, since these gelatines originate from animal sources the risks of prions and other infectious contaminations cannot be excluded. This fact makes FDA and EC authorities highly sensitive for process safety pre-cautions -when applying traditional gelatines for vaccine stabilisation purposes- up to safety standards which create high costs. This means that recombinant gelatine are an effective, safe and cost reducing alternative, warmly accepted by authorities as an alternative for animal-originated stabilisers. In case of freeze-dried vaccines, recombinant gelatine stabilisers have been proven to reduce the glass transition temperature of the vaccine, by which the shelf life of the vaccine increases considerably. Moreover, recombinant gelatine stabilisers make the freeze drying process robust, as the Tg temperature will be elevated during the sublimation process to guarantee the quality of the glass state of the matrix.

Finally, traditional gelatines have been shown to evoke an immune response in children, which risk is not present in case of the use of recombinant gelatines.

Vaccine- and drug stabiliser