Human milk-based nutritional fortifiers: Prolacta CEO unpacks regulatory considerations amid Japan expansion

14 Dec 2021 --- Mounting clinical evidence highlighting the benefits of human milk-based nutrition is driving demand within industry, particularly for premature and critically ill infants, Prolacta CEO Scott Elster tells NutritionInsight.

The US company is laying the groundwork to enter the market in Japan for its human-based milk nutrition. However, regulatory differences mean that while in the US the fortifier is classed as exempt infant formula, Japan classes the item as a drug – meaning there are strict requirements for conducting drug trials. 

“This is another industry first, led by Prolacta, which will allow us to introduce an exceptional level of human milk-based nutritional care for preterm infants in Japan,” Elster says. The drug trial began in October 2021 and is expected to be completed in 2023.

Scrutinizing fortifiers
The study will focus on three of the company’s products. Prolact+6 H2MF and +8 H2MF human milk fortifiers are the  first commercially available human milk fortifiers made from 100% human milk.

It is intended for premature/very low birth weight infants and provides concentrated nutrition to help support appropriate growth by providing essential calories, protein and minerals.

Prolacta’s focus at the moment are the markets in Japan and Europe.The third product is Prolact CR human milk caloric fortifier, targeting neonatal infants receiving low caloric content. 

“Prolacta is the only human milk company to qualify under Japan’s strict Pharmaceuticals and Medical Devices Agency drug trial standards for its products that have already been clinically proven in the US and are regulated by the US Food and Drug Administration (FDA),” says Elster.

“We are seeing that more and more premature infants born as early as 22 weeks are not just surviving, they are thriving – going home from the NICU sooner and developing into healthy, happy kids and then adults. This was not the case two decades ago,” he notes. This is a result of years of research on human milk-based nutrition that helps premature infants.

Benefits of human-based milk
Breast milk is the gold standard for infant nutrition, being especially critical for infants born prematurely, Elster highlights. A UK study earlier this year unraveled why breastfeeding provides better immunity than infant formula.

“While most full-term infants do well with cow milk-based nutrition, it is known to increase the risk of severe complications and feeding intolerance in preterm infants,” Elster underscores.  

Compared to cow milk-based nutrition, using pasteurized donor breast milk plus Prolacta’s 100% human milk-based nutritional fortifiers has been clinically proven to lower mortality and morbidity, support adequate growth and reduce hospital costs, he adds.  

It also reduces incidences of feeding intolerances and bronchopulmonary dysplasia, retinopathy of prematurity as well as improves long-term outcomes such as neurodevelopment. 

“Not all human milk-based fortifiers are created equally. Some human milk fortifiers are cow milk-based, others are derived from human milk. The major difference between cow milk-based and human milk-based fortifiers is the composition,” Elster states.

“Notably, the bioactive components unique to human milk such as immune cells and the wide spectrum of prebiotics known as human milk oligosaccharides are not easily manufactured, thus are missing from cow milk-based nutritional products.”

Surpassing food safety standards
As Prolacta’s human milk-based nutritional products are made using breast milk donations, there are stringent procedures to be adhered to so as to ensure quality and safety standards. 

The company says it is the first and only company to have developed, validated and implemented over 20 different tests for screening donor milk.

“Our breast milk donors are carefully screened and instructed on best practices; all human milk is DNA matched to the donor and tested for pathogens, viruses, adulterants and the presence of nicotine, marijuana, opiates and other substances. We are also the only company to test for BC enterotoxins, which heat will not inactivate,” Elster states. Breast milk is the gold standard that companies are trying to emulate.

“Our stringent processes for donor milk screening and testing were modeled on those used in the US plasma and blood industries and surpass food-product safety standards.” Additionally, the manufacturing process allows for a better quality end-product, he adds. 

“Prolacta’s human milk-based nutritional fortifiers have the highest bioactivity in the human milk industry due to our patented manufacturing process, which is demonstrated to retain the highest levels of essential bioactive components in human milk while ensuring pathogen inactivation.”

“We are proud to lead the human milk industry in the adoption of human milk-based nutrition and to have set the bar for quality and safety of donor human milk,” Elster notes. 

Ongoing progress
Developments in the infant nutrition space are fast-growing, with innovation and consumer demands spearheading developments. Last month, nutrition start-up Helaina raised US$20 million in series A funding, which it plans to use to deliver the first humanized infant formula.

Also last month, US-based Abbott launched its Similar 360 Total Care infant formula, described as the “closest formula to breast milk” in the US, which contains five human milk oligosaccharides identical to those found in human breast milk. 

TutleTree Labs is currently researching cell-based breast milk ingredients, a development it is accelerating after it landed US$6.2 million in an oversubscribed pre-series-A funding round from new and existing global investors. 

Similarly, Biomilq is on track to launch the world’s first cell-cultured human milk produced outside of the breast, according to the company, which received proof of complexity. 

By Andria Kades

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