NAMUH teams up with Ginkgo Bioworks on HMOs via precision fermentation as race to improve the nutrition of infant formula gathers pace

Human breast milk contains upwards of 200 HMOs, which comprise about 10% of the dry weight of mother’s milk and are not easily digested, but make their way to the large intestine, where experts postulate that they jump-start the infant’s microbiome, serving as food for certain gut bacteria such as B.infantis ​and acting as prebiotics.

While breastmilk is always best, infant formula brands have endeavored to get closer to the real thing in recent years for mothers unable to breastfeed for as long as they would like, by adding HMOs manufactured by genetically engineered microbes (typically E.Coli​ bacteria) via precision fermentation.

A growing number of startups also are developing platforms to produce other health-promoting components in breast milk, from immune-supporting proteins produced via yeast fermentation (Helaina) to bioactive peptides and lipids such as MFGM produced by lactating mammalian cells (Wilk Technologies​​).

The most prevalent HMOs in breastmilk​​​ ​can all be produced in fermentation tanks, with the top five (-​​ 2'-FL, 3-FL, LNT, 3'-SL and 6'-SL ) now featuring in Abbott’s Similac 360 Total Care formula​​​, for example.

San Diego-based startup Debut Bio, meanwhile, is working with Korean firm GeneChem to develop HMOs that have never been commercialized before using a novel 'cell-free' biomanufacturing ​​process.

Yeast as second generation production platform for HMOs​

While E.Coli​ bacteria has typically been used as the production microorganism for HMOs, NAMUH is carving out a distinct path in the space by using yeast, and is now tapping into Ginkgo's expertise in yeast strain engineering and fermentation process development to accelerate its commercialization plans, founder and CEO Dr Chaeyoung Shin told FoodNavigator-USA.

“The most abundant HMOs, around 10, account for over 90% of the concentration. We think abundance hints at the importance, so the most abundant 10 are likely to play more crucial roles. They have also been the most widely studied and their nutritional benefits are quite established.”​

While the FDA has not raised any objections to GRAS (Generally Recognized as Safe) determinations for HMOs produced by E.Coli, Shin said yeast was potentially a more ‘food-friendly’ host:  “We believe that yeast is a superior organism because there is zero endotoxin risk and yeast is an extremely food-friendly organism with a good, long track record for usage in human food.”​

The business model​

While the original plan was to serve as a b2b player, NAMUH now plans to launch its own infant formula featuring HMOs it produces in-house, said Shin.

“We are formulating with our HMOs and other human milk-like products – with more partnerships coming - to formulate an infant formula product closest to human breast milk at the molecular level. We will also sell our products directly to consumers.”​

Regulation, funding, manufacturing setup​

As for the regulatory pathway, she said: “We will be filing for GRAS for the HMOs and will go through the infant formula clinical trials, which is mandatory for new infant formula formulations in the US. Could this take years? Yes, but not more than two to three years, fingers crossed.”​

Asked about funding for the company, which is based in Alameda and backed by 8VC, Berkeley Catalyst Fund, SOSV, and private investors, she said: “I can't disclose too much but we're seeking funding that will bring us to market. ​

“​We don't need too much fermentation volume, as we are just starting out as a formula company and HMOs are also one of the components of the formula. ​

“We are at the piloting stage currently and we have a very seasoned CTO in Dr. Paula Hicks​ [who has worked in the precision fermentation field for years at companies including Evolva] who was involved in bringing multiple ingredients from bench to commercialization.”​

She added: “We have a partner and are speaking with more potential partners for piloting/manufacturing.”​