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Should human milk-based nutritional products for premature infants be homogenized? More research is needed, new journal article says

DUARTE, Calif., Mar. 23, 2022 – Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk-based nutritional products for premature, critically ill infants, announced today the publication of a journal article that summarizes existing evidence on the impact of homogenization on human milk-based nutritional products. The article focuses on changes to the macromolecular structure of the milk fat globule (MFG) and the subsequent impact on digestion and was published in December in the peer-reviewed journal Current Developments in Nutrition.1

Authored by Sarah M. Reyes, Ph.D., MSc, and colleagues, “The Impact of Homogenization on Donor Human Milk and Human Milk-Based Fortifiers and Implications for Preterm Infant Health” uses published data to create a conceptual framework for the potential implications of homogenized human milk-based nutritional products on preterm infant health and suggests avenues for future research.

“Homogenization disrupts the milk fat globule, which may lead to premature digestion of bioactive components, including sphingolipids and long-chain polyunsaturated fatty acids (LCPUFAs), linked to favorable neurological outcomes. The implications of these changes for infant health are unknown,” according to Reyes, scientific liaison, human milk and clinical research, at Prolacta.

Homogenization is a process that evenly disperses two liquids to create a single uniform mixture. In the dairy industry, homogenization is used to improve cow milk’s taste, consistency, and appearance, as well as to extend its shelf life. Dairies homogenize cow milk to disperse fat droplets and prevent the cream from rising to the top.

Human milk is a complex, dynamic bioactive fluid with a myriad of compounds that make it the preferred nutrition for infants to support their immunity, growth, neurodevelopment,2 and overall long-term health.3

“The well-established clinical benefits of human milk-based nutritional products only apply to currently available non-homogenized products. The safety and efficacy of homogenized human milk-based nutritional products have not been established,” Reyes wrote.

“Human milk-based nutritional products are not created equally,” said Melinda Elliott, chief medical officer for Prolacta, practicing neonatologist, and a study co-author. “As human milk researchers and medical professionals, it is our opinion that the use of industrial processing techniques such as homogenization, with or without high-heat processing, should be avoided for human milk-based nutritional products until their safety and efficacy have been established.”

About Human Milk-Based Products

The major difference between cow milk-based and human milk-based products is the composition — notably, the bioactive components that are unique to human milk. These include immunoglobulins, lactoferrin, milk fat globule membrane, and the wide spectrum of prebiotics known as human milk oligosaccharides (HMOs), which are not easily manufactured and thus are greatly decreased or missing from cow milk-based nutritional products.4 Bioactivity is thought to support infants’ immunity, development, growth, and long-term health.2

Prolacta’s 100% human milk-based nutritional products have the highest bioactivity in the human milk industry.5 Prolacta’s nutritional products are vat pasteurized using profiles defined by the U.S. Food and Drug Administration (FDA) to ensure pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible.5 Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.6,7

About Prolacta Bioscience

Prolacta Bioscience® Inc. is a privately held, global life sciences company dedicated to Advancing the Science of Human Milk® to improve the health of premature, critically ill infants. Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals. More than 80,000 premature infants have benefited from Prolacta’s nutritional products worldwide to date.8 Established in 1999, Prolacta is the world’s leading provider of human milk-based nutritional products for hospital use and is also exploring the therapeutic potential of human milk across a wide spectrum of diseases. Prolacta maintains the industry’s strictest quality and safety standards for screening, testing, and processing donor human milk. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented, FDA-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional composition and bioactivity of its human milk-based products. Prolacta is a global company with headquarters in Duarte, California, and can be found online at, on Twitter, Instagram, Facebook, and LinkedIn.

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Media Contact:
Loren Kosmont


  1. Reyes SM, Patra B, Elliott MJ. The impact of homogenization on donor human milk and human milk-based fortifiers and implications for preterm infant health. Curr Dev Nutr. Published online December 8, 2021.
  2. Gila-Diaz A, Arribas SM, Algara A, Martín-Cabrejas MA, López de Pablo ÁL, Sáenz de Pipaón M, Ramiro-Cortijo D. A review of bioactive factors in human breastmilk: a focus on prematurity. Nutrients. 2019;11(6):1307. doi:10.3390/nu11061307
  3. American Academy of Pediatrics. Breastfeeding and the use of human milk. Section on Breastfeeding. Pediatrics. 2012;129(3):e827-e841. doi:10.1542/peds.2011-3552
  4. Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002. PMID: 23178060; PMCID: PMC3586783.
  5. Data on file.
  6. Meredith-Dennis L, Xu G, Goonatilleke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks. J Hum Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635
  7. Lima HK, Wagner-Gillespie M, Perrin MT, Fogleman AD. Bacteria and bioactivity in Holder pasteurized and shelf-stable human milk products. Curr Dev Nutr. 2017;1(8):e001438. doi:10.3945/cdn.117.001438
  8. Estimated number of premature infants fed Prolacta’s products from January 2007 to December 2021; data on file.