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 sustainably produced 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 sustainably sourced Squalene offers multiple benefits:
The highly purified Squalene complies with the monograph specifications of the Ph. Eur. monograph 2805 for squalene used as an adjuvant in vaccines. 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 sustainably sourced Squalene is currently available for research use only.
- Natural lipid belonging to the terpenoid family
- Vaccine adjuvant
- Human vaccines
- Veterinary vaccines
- Component in emulsion vaccine adjuvants
Frequently asked questions
Squalene is a natural lipid belonging to the terpenoid family. Its name is derived from the Latin name squalus for shark.
Most plants, fungi, and animals produce squalene as a biochemical precursor in sterol biosynthesis, including cholesterol and steroid hormones in the human body.
Its major role currently is in influenza vaccines. It is utilised in squalene-based emulsion adjuvants in several seasonal vaccines such as FLUAD™ and FLUAD™ Tetra as well as pandemic preparedness vaccines such as Pandemrix™, Prepandrix™ and Humenza™.
Clinical development with vaccine formulations using a combination of PHAD™ and squalene as adjuvant system is ongoing. AAHI (The Access to Advanced Health Institute) has developed their GLA-SE* adjuvant formulation currently included in various vaccine development projects such as tuberculosis, malaria, HIV, schistosomiasis, and herpes zoster.
Currently, all marketed vaccines use shark-derived squalene.
*GLA = Glucopyranosyl Lipid A (equal to PHAD)
It is incorporated in squalene-based emulsions, together with surfactants and other lipids. Tween™ 80, Span™ 85, Synperonic PE/F 68 (Poloxamer 188) or derivatives of phosphatidylcholine, which are available from Avanti (for example DSPC, DMPC, DLPC, DOPC). It can also be combined with PHAD™.
Contact our experts if you would like to discuss .
In short, the benefits of squalene-based emulsions are as follows:
- Established safety profile.
- High tolerance in both adults and children.
- Increased vaccine immunogenicity.
- Dose sparing effects.
- Broadened cross-strain neutralisation in influenza vaccines.
a. Addition of vitamin E as an antioxidant.
b. Filling the product under a nitrogen blanket.
We have two variants available, squalene with and without vitamin E. Both variants will be under nitrogen blanket. The content of vitamin E, serving as an antioxidant, is between 400 and 600ppm. This amount of vitamin E is not sufficient for immunostimulatory activity.
The reliance of animal derived squalene could risk being banned in the future. Non-animal derived squalene offers not only a more sustainable but also a more robust supply chain since it eliminates the supply risk of a shark fishing ban or shark extinction.
2. High purity
Our sustainably sourced Squalene distinguishes itself in terms of purity from other non-shark-derived squalene products available, to our knowledge. Our Squalene not only satisfies the Ph.Eur. monograph requirements with its ≥99% purity but is comparable to shark-derived squalene which equally has a purity >99%, making it well-suited for use in vaccines.
As a well-controlled fermentation process is used to obtain squalene, there is high consistency, this is low batch-to-batch variability.
Our partner Amyris' expertise in synthetic biology in conjunction with our purification excellence gives access to a sustainable source that contributes to an environmentally-friendly production without endangering shark populations which play a key role in marine ecosystems.
Product brochures & guides
Title: Addressing the challenges of vaccine formulation - CP22
A complete vaccines brochure covering our offering across the platforms.
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