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

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.

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.

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.

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.