Purifying 2’FL – the most abundant HMO in breastmilk – from bovine or human milk is unsustainable, prompting several firms to develop approaches utilizing genetically engineered microbes such as E.Coli to produce 2’FL more efficiently in fermentation tanks.
“We leveraged our industry-leading technology for production of non-GMO certified natural sweeteners to instead make HMOs with simple enzymes rather than recombinant organisms,” explained VP of R&D Dr Casey Lippmeier, who said infant formula manufacturers could anticipate market entry of Conagen’s 2’FL “in the next few months.”
“We have made impressive investments in our capabilities for high-throughput, automated enzyme identification, design and screening,” he added.
“From this expanded platform, we were able to identify and improve upon an interesting natural pathway for the biosynthesis of 2’FL which is more efficient than established routes. A patent application has been filed on this process…
“Our new process is much more efficient than existing production processes. We are actively scaling up for production in the near future,” he told FoodNavigator-USA.
Human milk oligosaccharides (HMOs) are the third largest solid component in breastmilk after fat and lactose, and are responsible for stimulating the immune system by promoting good gut bacteria, strengthening the gut barrier function and blocking pathogens.
The GMO factor
As for the importance of the Non GMO factor, he said: “A number of infant formula brands are sold with non-GMO labels. For consumers of these brands, HMOs were simply not available until now. We simply want these important molecules to be available to as many infants as possible. We do intend to submit our process for evaluation by the Non-GMO Project as we have for our other enzymatic processes which have met their criteria for food ingredients.”
‘The GRAS self-affirmation is underway right now’
Asked about the regulatory status of Conagen’s 2’FL, he said: “The GRAS self-affirmation is underway right now. We will then send our GRAS notification to the FDA for anticipation of the ‘No Objection letter.’”
But given that HMOs are the third largest solid component in human milk after fat and lactose, does adding a tiny amount of just one HMO to infant formula really confer any meaningful benefits?
“Although more studies are warranted, the weight of evidence indicates that fortification with 2’FL does indeed confer meaningful health benefits to infant formula-fed babies,” claimed Dr Lippmeier.
“More conclusive data on the benefits will come from larger controlled studies using dose range effects on standardized, measured outcomes. Vandenplas et al., ably reviewed the literature on this subject in 2018.”
Beyond their use in infant formula, HMOs also have potential in the dietary supplement market for immune and sports performance products for adults, claimed Dr Lippmeier.