The company has already teamed up with US firm CP Kelco for production and marketing support, and expects the ingredient will be ready for commercialization by mid-2009.
The launch follows Fluxome’s development of a patented technology that allows it to produce nutraceutical ingredients through fermentation of microorganisms – in this case baker’s yeast.
This produces a reasonably priced, high purity resveratrol ingredient, which is not subject to by-product contamination or supply insecurities, explained Fluxome CEO Steen Andersen.
Resveratrol challenges
Resveratrol is an antioxidant naturally found in grapes and red wine, mulberries, peanuts and 'knotweed' (polygonum cuspidatum). It has been shown to have positive anti-aging benefits, and has also demonstrated benefits in diabetes, heart health, obesity and some cancers.
These documented health benefits have generated significant interest in the ingredient from the supplements industry in particular.
However, the natural sources of resveratrol do not deliver the ingredient at high enough levels in order to receive the maximum benefits. For example, red wine of the pinot noir variety is thought to contain only 3.1mg of resveretrol per liter.
Because there are so few clinical studies conducted on humans related to the compound, there is no golden standard for the necessary dosage levels. However, using animal studies as a guideline, minimum levels are thought to be 30mg per person per day.
This means that suppliers have often turned to synthetic forms of resveratrol in order to obtain adequate levels. DSM, for example, earlier this year launched its synthetic Resvida reesveratrol. To read the NutraIngredients-USA.com article on that, click here.
Yeast fermentation
Fluxome says its production process is able to produce a “natural” ingredient.
It works using genetically modified yeast. The company uses a recombinant yeast strain (Saccharomyces cerevisiae), and removes the genes that would normally produce ethanol and carbon dioxide in the fermentation process.
In their place are inserted other genes that are able to produce resveratrol. These genes are typically taken from other microorganisms or from plants, said Andersen.
Although the firm would not specify the exact pathway chosen in its production process, it said that trans-resveratrol production can be achieved through the aromatic amino acids such as L-phenylalanine or L-tyrosine.
The controlled fermentation using this modified yeast results in a biomass consisting of yeast and resveratrol. The resveratrol, which is extracted through a separation process, has a minimum 98 percent purity, said Andersen.
This is priced at a competitive level to other high quality 98 percent purity products, he said.
Approvals
Fluxome is first targeting the North American market with its new ingredient, as GMO concerns in Europe mean that a Novel Foods application is likely to take at least three years.
Andersen said the firm is in the final process of putting together its safety package for the ingredient’s use in supplements in the US. By March 2009, it expects this will be ready to go, with full-scale production and safety documentation in place.
Fluxome will also be submitting a self-affirmed GRAS (generally recognized as safe) status to FDA in order to open up the food and beverage market for the ingredient. It expects this will be ready in March 2009, and that it will receive the regulator’s letter of non-objection by mid-2009.
The company, which introduced its concept to industry at the Supply Side West trade show in Las Vegas last month, said its trans-resveratrol can be also be used in the cosmetics and pharmaceutical industries.
CP Kelco will undertake the production of the ingredient, as well as its sale to the food market. Fluxome will supply the dietary supplement market.
Future development
With the technology off the ground, Fluxome expects to soon be able to use it for the production of omega-3s. Within 12 months, it said it should have a yeast-fermented EPA ready for commercialization. In two years, it expects to market DHA and ARA ingredients.
Andersen said the company has identified around 18 nutraceutical ingredients that could be manufactured using its fermentation process, and it expects to be able to bring one new ingredient to market per year.
“The production of nutraceutical ingredients by fermentation through fermentation of microorganisms will play an increasingly important role in supplying high quality nutraceutical ingredients,” it said.