Non-shark derived, engineered by synthetic biology. Our pharmaceutical-grade Squalene has superior purity, naturally setting it apart on the market.
An innovative alternative to shark-derived squalene using synthetic biology
There is a significant need for a highly purified alternative to shark-derived squalene to meet the requirements of the vaccine industry. To mitigate the devastating impact on deep-sea shark populations, we are proud to offer a sustainably sourced, sugar-derived Squalene carrying the same benefits as shark-derived squalene.
Pharmaceutical grade Squalene using synthetic biology
Produced using cutting-edge technology that centres on synthetic biology, our pharmaceutical-grade squalene has superior purity, naturally setting it apart on the market. Fermentation based, our Squalene uses yeast isoprenoid pathway engineering, through proprietary technology developed by Amyris. Our purification excellence enables access to a highly purified grade for human and veterinary applications.
What is squalene? And why is there a strong need for vaccine formulations?
Squalene is an organic compound with powerful bioactive properties1. As a naturally occurring oil, squalene has successfully been used in various emulsion-based vaccine adjuvant formulations. They do not only initiate potent innate and adaptive immune responses2 but also have established safety records. This has ignited interest in squalene and inspired the search for more sustainable alternatives.
Squalene-based emulsions
Squalene-based emulsions are used in licensed seasonal and pandemic influenza vaccines. Furthermore, there are clinical development projects for prophylactic vaccines ongoing, for example those against tuberculosis, shingles, schistosomiasis, HIV and other severe diseases, combining squalene with a TLR4 agonist in their emulsion adjuvant.
What is squalene?
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.
Find more information like this in our Frequently Asked Questions here.
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Sustainably sourced Squalene
Our sustainably produced Squalene is based on cutting-edge technology using synthetic biology to obtain squalene from a fermentation process.
EXCLUSIVE WHITEPAPER: Vaccines for a more sustainable future
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Non-shark derived, sustainably sourced Squalene
Squalene in vaccines
Squalene in vaccines has primarily been sourced from sharks, and this has contributed to worrying environmental consequences. Oceanic shark populations have dropped by 71.1% from 1970 to 20183. In fact, half of oceanic shark species are now endangered4. Sourcing shark liver oil is furthering this state of peril. Not only is this threatening shark populations, putting pressure on their already long reproductive cycles, but it also means that squalene is in short supply.
Replacing shark-derived squalene with sustainable alternatives
Sourcing squalene from deep-sea sharks is unsustainable. Its use in life-saving vaccine formulations creates a global strong demand for alternative sources meeting vaccine manufacturer's requirements.
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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)
Squalene is not an adjuvant on its own. It is an important ingredient in some vaccine adjuvant systems.
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 .
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.
As a terpenoid, squalene contains unsaturated bonds and is sensitive to oxidation. There are two options for protecting it:
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.
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.
1. Security of supply
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.
3. Consistency
As a well-controlled fermentation process is used to obtain squalene, there is high consistency, this is low batch-to-batch variability.
4. Sustainability
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.
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.
3. Consistency
As a well-controlled fermentation process is used to obtain squalene, there is high consistency, this is low batch-to-batch variability.
4. Sustainability
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.
Vaccines for a more sustainable future
EXCLUSIVE WHITEPAPER
The vaccines of tomorrow revolve around sustainable supply chains and access to scalable commercial supplies that do not put undue pressure on the natural environment. It is our responsibility to future-proof vaccines by focusing on longevity in our processes. With combined global efforts, we can enhance the global health infrastructure, leading us to develop better vaccines against more diseases and supporting our preparedness for future outbreaks.
We believe that lobal collaborations are the cornerstone of creating a greener planet. Let's do all we can today, to generate a sustainable future we're proud of.
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Sustainable vaccines
We envision a future where everyone gets the vaccines they need. This reality relies on maintaining vaccine access and continuing to innovate in this realm. The responsibility is on us all to not only select sustainable ingredients, but to secure supply chains and sources that will not deplete in the future.
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1. https://www.mdpi.com/1424-8247/15/3/265#B16-pharmaceuticals-15-00265
2.https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1415684
3. https://doi.org/10.1038/s41586-020-03173-9
4. https://doi.org/10.1038/s41586-020-03173-9
2.https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1415684
3. https://doi.org/10.1038/s41586-020-03173-9
4. https://doi.org/10.1038/s41586-020-03173-9