Major Advancement in High Purity Human Breast Milk Fat Ingredient Development for Infant Nutrition, Using Precision Fermentation
A mom bottle feeding an infant.
Aug 5, 2025
South San Francisco, CA
Scientists at a San Francisco food biotech startup called Yali Bio have announced the successful completion of a NIH funded research to produce a high purity, human breast milk fats called OPO, using precision fermentation.
Human milk fat accounts for about 50% of the energy in breast milk and is crucial for infant growth and development. The importance of long-chain fatty acids arachidonic acid (ARA) and docosahexaenoic acid (DHA), the two primary long-chain omega-6 and omega-3 fatty acids are widely recognized for cognitive, visual, and immune development. Advancements in biotechnology and precision fermentation by companies like DSM have made possible a global scale adoption of DHA and ARA in infant formulas. While these bioactive lipids components have become standard additions to most formulas, the main structural fat in human milk (OPO, chemically described as 1,3-dioleoyl-2-palmitoyl-glycerol or 1,3-dioleolyl-2-palmitate), which has been shown to be crucial for regulating fat and calcium absorption, both vital for energy and bone growth during an infant’s first 1000 days, remains mostly produced by an enzymatic manufacturing process developed by speciality fats and oils companies such as Bunge, AAK and Wilmar. The enzymatically produced OPO fat ingredient has been successfully commercialized in major Chinese infant formulas (the largest infant formula market by geography), but remains absent in U.S. & European infant formula products. The complexity of the production method, the reliance on high-purity palm fractions and cost of the enzymes may have likely limited its adoption in Western markets.
Scientists at Yali Bio completed a grant from the National Institutes of Health’s (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development, and shared the exciting results. ‘Within a 24-month of R&D effort, which one full year of it is fully funded by the NIH grant, Our team of scientists have advanced the development of a very high purity sn-2 palmitate OPO product, a bit to our surprise, reached 66-78% sn-2 level, which is typically seen in human breast milk.’ Explains Yulin Lu, Ph.D. the founder and CEO of the company. 'The technology has been advanced to a very reproducible fermentation scale in our laboratory, with an integrated downstream process developed to make the final product, purified OPO.’
Figure 1: Yali Bio’s precision fermentation platform produced OPO fat sn-2 palmitate % demonstrated at 66-78%, in comparison to > 70% in human breast milk, and two commercially available OPO products (Betapol and Infat) using the traditional enzymatic processes.
The San Francisco-based company is well positioned to continue commercializing the OPO technology, with key milestones planned for FDA GRAS filing, and is in close engagement with infant formula manufacturers for partnering. “We are learning a great deal about infant nutrition, the significant science-based approach and rigor the broader industry has been committed to for novel bioactive ingredients development, and now have a global reach of commercial interest from North America, Europe and Asia markets”, the company states.
