Yali Bio develops breast milk compound from yeast for improved infant formula
Specializing in the development of animal-free fats for meat and dairy alternatives, Yali Bio’s production of OPO highlights a significant opportunity to improve infant formula that contains nearly the same nutritional content as human breast milk.
The inclusion of OPO in infant formulas has potential to improve current products (powdered, liquid concentrate and ready-to-fix formats), which typically use plant-based oil and dairy fats for the base formulation, Lu said, adding it is suitable for all current formats.
While the World Health Organization recommends infants in the first six months of life consume breast milk, which contains OPO and a variety of other bioactive components, formula offers a viable option for the 60% of women who do not breastfeed for that long, according to the CDC.
Clinical studies show that OPO provides positive nutritional benefits for infants like improved energy intake, reduced constipation and increased bone mineral density; while qualitative studies show less crying and better sleep with OPO consumption.
Formula shortage triggered a race to market for alternatives
The February 2022 recall of three powdered formula brands produced by Abbott Nutrition in its Sturgis, Mich., facility highlighted the potential risks of contaminated formula to infant health, as the products were linked to at least two infant deaths and several more illnesses from the rare and fatal bacterial, Cronobacrer sakazakii.
With more than 130m infants born around the world who consume formula at some point in their lives, the shortage of formula created a race to bring other options to the market.
Yali Bio’s NIH-backed funding has enabled the company to show that precision fermentation in a yeast host (versus the more common microbial hosts used in the process) to make highly valued fat ingredients that can be used for infant nutrition, Lu explained.
Finding a path to commercialization
The company is currently working with the infant nutrition industry to understand the rigorous regulatory approval process and will move forward with a B2B business model.
While food technology uses a self-GRAS process to meeting safety requirements, infant food safety undergoes both GRAS and FDA compliance around the nutritional quality of a formula, which Lu explained is another layer of complexity in bringing Yali Bio’s OPO to market.
“There are big infant formula brands on the market that really understand the … market, the regulatory complexity and even the supply chain demand and manufacturing risks in the space. So that’s our approach to figuring out what is the best path to commercialize these novel ingredients and how we can work with the stakeholders in this industry to commercialize it,” Lu said.
