PhytoSquene® plant-based, pharma-grade squalene for vaccine adjuvants

First plant-based squalene in the world in GMP quality

Preserving biodiversity and ensuring safety with non-animal-derived squalene in pharma quality

PhytoSquene® is our non-animal-derived squalene that can be used in vaccines and other pharmaceutical applications. This alternative to animal-derived squalene has many benefits. PhytoSquene® reduces the need to source pharma-grade squalene from sharks, therefore helping to preserve biodiversity and ecosystems. It is non-immunogenic and has a high and consistent quality. No CMR (carcinogenic, mutagenic or toxic) processes are involved in manufacturing. PhytoSquene® is compliant with European Pharmacopoeia regulations (Ph. Eur. monograph 2805).

Squalene and its application in vaccine adjuvants for parenteral drug delivery

Squalene is a natural lipid that is used in a range of applications including cosmetics, nutraceuticals and pharmaceuticals.

Chemical structure of squalene

In the healthcare industry, squalene is used in parenteral drug delivery as an adjuvant. Vaccine adjuvants are additives that stimulate the body’s immune response to the active ingredient in a vaccine. Squalene allows the transport of antigens for their recognition by cells such as macrophages or dendritic cells. It is used, for example, in some influenza vaccines.

Vaccine adjuvants such as squalene reduce the amount of active ingredient needed in a vaccine, thus making it quicker and easier to scale vaccine production and reducing the chance of any side effects.

Sourcing of squalene and sustainable development

Squalene is found in shark livers, higher fungi, yeast, microbes and many plant sources. Up until now, shark liver oil, for example, from the spiny dogfish (Squalus acanthias) has been the only source of pharma-grade squalene. It takes between 2,500 and 3,000 sharks to extract roughly a ton of the product.

PhytoSquene® is our non-animal-derived alternative that is based on amaranth oil. Amaranth (Amaranthus caudatus) is a herbaceous plant that is cultivated in many regions of the world as a crop.  It can be grown in colder regions including Argentina, Bolivia and Peru. Amaranth oil is extracted from the amaranth seed via supercritical CO2 reduction. To extract the squalene the amaranth oil is enriched via a membrane the crude squalene produced is then purified via chromatography and isolated via distillation before drying and packing.

Disadvantages of animal-derived squalene / shark squalene

Animal-derived squalene contributes to loss of biodiversity and depletion of shark populations such as the spiny dogfish (Squalus acanthias). In the past, the shark species Squalus acanthias used to be one of the most populous in the world. However, overfishing has led this species to be classified in the IUCN Red List of threatened species as vulnerable globally and critically endangered in the Northeast Atlantic. Although measures have been in place in EU waters since 1999, these have for the most part been ineffective, and it is unclear if populations will be able to recover.

There are also safety issues concerned with animal-derived squalene. Many fish are highly contaminated with methylmercury which is extremely toxic and is a bioaccumulative environmental toxicant. Animal-derived squalene is also susceptible to batch-to-batch variations and variable quality, which can complicate regulatory procedures. Further, many patients cannot use animal-based products for cultural or religious reasons.

PhytoSquene® offers a sustainable non-animal-derived alternative for pharmaceutical applications.

Sustainability drives our plant-based squalene solution

Evonik is focusing on the 12 Sustainable Development Goals (SDGs) that are most relevant for our business. These can be grouped into four categories: fighting climate change, driving circularity, safeguarding ecosystems and ensuring health and well-being.

PhytoSquene® protects life below water by avoiding the need to catch sharks. This helps conserve the marine ecosystems and increases biodiversity. By using renewable and biodegradable raw materials like amaranth, PhytoSquene® is helping to drive circularity. Using PhytoSquene® in parenteral applications increases patient safety and patient acceptance. Adding adjuvants to vaccines can increase the power of an API, which means less active ingredient must be used. This reduces potential side effects and enable the manufacture of a larger number of vaccines. It provides a non-animal derived option for patients who reject animal-based products for cultural or religious beliefs.

Work with us to bring patients safer vaccines that help preserve shark populations

We provide you with PhytoSquene® our non-animal-derived squalene that you can use for your formulation needs. For further information or to request a sample, get in touch with us!

Frequently asked questions (FAQ)

Squalene (also Spinacene or Supraene, CAS 111-02-4) is an organic compound that is a natural oil found in shark livers, higher fungi, yeast, microbes and many plant sources. Its name comes from the Latin "squalus" in reference to the sharks it is often sourced from. In healthcare applications, squalene is important for parenteral drugs, especially as an excipient in adjuvant systems. Pharmaceutical-grade squalene is currently sourced from sharks.

Influenza vaccines commonly use squalene as part of their adjuvant systems (e.g. AS03 from GSK, MF59 from Novartis, AF03 from Sanofi or AddaS03™ from InvivoGen). Squalene-based vaccine adjuvant systems are predominantly featured in influenza vaccines. Other adjuvant systems containing squalene are also being developed to tackle diseases such as tuberculosis, malaria, HIV, schistosomiasis, and herpes zoster.

Squalene is an important component in adjuvant systems that are used in drug products such as vaccines. It is blended into emulsions with surfactants and other lipids. Using squalene in vaccine adjuvant formulations has many advantages. It has a well-established safety profile and high tolerance. It improves the immunogenicity of vaccines, requiring lower or less frequent doses of a drug.

Animal-derived squalene is sourced from shark liver. Sharks are essential for our ecosystems, but many shark populations are listed as endangered species. As the demand for pharmaceutical squalene grows, shark squalene will be unable to provide the quantities needed. Also, many fish and sharks are highly contaiminated with methylmercury, a bioaccumulative environmental toxicant. This can make regulatory processes for animal-derived squalene difficult. In terms of quality, there is higher batch-to-batch variation with animal-derived squalene, due to variation in the quality and purity of the raw materials.

The manufacturing process for PhytoSquene® involves enrichment and purification. It is made from amaranth oil and then enriched using nanomembrane filtration. Purification of the squalene is carried out with chromatography to Ph. Eur. specifications/Ph. Eur. monograph 2805.

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