Today, DuPont Nutrition & Health and Inbiose NV celebrated regulatory approval of their first human milk oligosaccharide (HMO) ingredient for infant formula in the European market.

Human milk oligosaccharides, complex carbohydrates found in breast milk, are an important breakthrough innovation in infant formula, developing a product with more of the health benefits associated with human milk.

There are more than 100 HMOs found in human breast milk, with 2′-fucosyllactose (2′-FL) being the most abundant. In 2016, Inbiose and DuPont Nutrition & Health (DuPont) announced a joint development and licensing agreement for the exclusive rights to produce and commercialize 2′-FL and other selected fucosylated HMOs for food applications.

"After many years of critical research and significant investment, we are delighted to see the first of our range of human milk oligosaccharides becoming commercially available, thus addressing a major gap in the nutritional composition of infant formula," said Prof. Wim Soetaert, Inbiose executive chairman. "Thanks to our successful collaboration with DuPont, our first HMO is now commercialised, with many others to come."

"The substantial equivalence dossier for 2′-FL received EU Novel Food approval in December 2017," said Paul Tenning, regulatory affairs manager, EMEA, for DuPont, "and we are excited to be able to bring this important new ingredient for infants and children into the European market."

2′-fucosyllactose, which will be marketed by DuPont under the brand name CARE4U™, is already approved for use in dietary supplements, with potential applications related to digestion and immune health.

A production and commercialisation platform for specialty carbohydrates

Until recently, complex carbohydrates such as HMOs were not available in larger quantities from extractive sources (e.g., cow’s milk), and the few that could be chemically synthesized were prohibitively expensive. Inbiose developed a proprietary platform technology to produce specialty carbohydrates such as human milk oligosaccharides. This fermentation-based production method has now been developed to industrial levels, allowing the large-scale production of 2′-FL that is fully identical to the 2′-FL HMO found in human milk.

"Our competency lies in the rapid development of cost-effective production methods for specialty carbohydrates," said Joeri Beauprez, Inbiose CSO. "Through our platform technology, we will continue to excel in the production of such ingredients, making these ingredients and their health benefits available to society at large."

As a leading manufacturer of food ingredients and pre- and probiotics with decades of experience developing ingredients for infant formula, DuPont was a natural partner for commercialization of selected fucosylated HMOs.

"We will be the leading supplier of HMOs for infant nutrition and beyond," said Steen Lyck, global business development leader for DuPont. "Our unique experience and capabilities give DuPont the ability to leverage synergies with multiple HMOs and probiotics; 2′-FL is just the beginning."

2’Fucosyllactose and HMOs

While human milk remains the gold standard for nourishing a baby’s growth, development and immune system, the reality is that not every mother is able to breastfeed; the large-scale production of human milk oligosaccharides brings infant formula an important step closer to human milk.

HMOs are the third-most-abundant solid component in human milk, after fat and lactose, and until now these complex carbohydrates represented the largest compositional gap between human milk and infant formula. HMOs are important for the health of newborns and developing infants: They are believed to exert numerous important physiological functions, including facilitating the establishment of a healthy microbiota, blocking the attachment of pathogens, and promoting immune-system development.

Currently, more than 100 different HMOs have been identified in human milk, with 2’fucosyllactose being by far the most abundant. It has been demonstrated to be safe and well-tolerated, and recent studies show 2′-FL added to infant formula can help in the establishment of beneficial gut bacteria such as Bifidobacteria; published studies show that a healthy balance of bacteria in the gut is linked to a strong immune system.