Squalene has traditionally been sourced from shark liver oil which represents an ecological threat. This led to the search for sustainable alternatives with equivalent properties suitable for vaccine development.
Our Sustainable Squalene is based on cutting-edge technology using synthetic biology to obtain squalene from a fermentation process. The final purification step turns it into a pharmaceutical grade Squalene suitable for vaccine formulations.
Such Sustainable Squalene offers multiple benefits:
All test parameters and specification limits required by the Ph. Eur. monograph 2805 for squalene used as an adjuvant in vaccines are met by our highly purified Squalene. Its purity exceeds the minimum requirements of the Ph. Eur. monograph with a purity of at least 99% and meets the stringent requirements of the vaccine industry.
It is molecularly identical to shark-derived squalene with demonstrated stability in emulsion adjuvants.
The sustainable production process ensures a scalable and secure supply chain and helps to protect shark populations which play a key role in maintaining marine ecosystems.
Squalene-based emulsions are used in licensed seasonal and pandemic influenza vaccines. Furthermore, there are clinical development projects for prophylactic vaccines ongoing, such as those against tuberculosis, shingles, schistosomiasis, HIV and other severe diseases, combining squalene with a TLR4 agonist in their emulsion adjuvant.
Our Sustainable Squalene is available in GMP quality.