Breastfeeding has long been promoted as the most effective way to ensure child health and survival. According to the World Health Organization’s (WHO) ‘breast is best’ philosophy, breastmilk is the ideal food for infants.
“It is safe, clean and contains antibodies which help protect against many childhood illnesses,” notes the UN agency.
However, nearly two out of three infants are not exclusively breastfed for the recommended six months – a rate that has not improved in 20 years. Globally, three in five babies are not breastfed in the first hour of life.
This is largely due to insufficient supply, suggests Shayne Giuliano, CEO of cellular agriculture start-up Pure Mammary Factors. “There’s not enough human milk in the world to feed all babies human milk,” he told delegates at the Mylkcubator demo day last week.
“Because it’s never been possible to make enough human milk for babies…until now.”
Developing human milk proteins, without the human
Pure Mammary Factors, a recent graduate of Spanish incubation programme Mylkcubator (established by dairy major Pascual’s innovation arm, Pascual Innoventures, and food tech accelerator Eatable Adventures), is on a mission to disrupt the infant nutrition sector.
Human milk proteins are ‘perfect’ for babies, Giuliano stressed. When human milk is unavailable, babies are fed infant formula – to ensure the child consumes enough tryptophan.
Tryptophan is an essential amino acid required for normal growth in infants, as well as for the production and maintenance of the body’s proteins, muscles, enzymes, and neurotransmitters.
“Do you know what truly has the perfect amount of tryptophan?” asked Giuliano. “Human milk. And cell-cultured human milk.”
Pure Mammary Factors is leveraging cellular agriculture to develop human milk, without the human. “It starts with the cell,” explained the CEO. The start-up stimulates and feeds it, turning it into a ‘cell factory’.
The ‘bottleneck’ of the entire process lies in feeding the cells. Giuliano said a ‘new industry’ is required, one that is ‘dedicated to mixing mountains of amino acids’ and fermenting ‘mountains of stimulating proteins’ that feed cells, so that in turn, Pure Mammary Factors can ‘feed the world’.
“This is what Pure Mammary Factors is doing. We are preparing the world to feed the cells, we are mixing the raw materials, we are fermenting the stimulating proteins, we are incubating the breast milk substitutes with corporate partners around the world.
“As we scale our team, we will relentlessly innovate to make human milk cheaper and safer and bigger, until the world has a surplus of human milk.”
‘Humanizing’ bovine formula
Pure Mammary Factors has produced its first cell lines for fermentation of its ‘most viable’ stimulating protein, and expects to have proteins ready for commercialisation by the end of the year.
Its first pilot production facility, based in Hillsborough, North Carolina, is in operation, where it is scaling its first fermented stimulated protein production and optimising its first research-grade pure cell culture medium.
“With the supply chain struggling to keep bovine formula on the shelf, there’s never been a better time to invest in bovine replacement research,” said Pure Mammary Factors COO Scott Matthews.
“We’ve already signed our first letter of intent (LOI) with Big Dairy to incubate humanised bovine formula research. We believe babies and mothers deserve whole human breastmilk substitutes as an ultimate feeding option, without compromise.”
The profit-potential is significant. Breast milk substitutes is a ‘big business’, and the fastest growing food segment in terms of CAGR, said CEO Giuliano.
Valued at $24.2bn back in 2018, Allied Market Research estimates the global infant nutrition market will grow at a CAGR of 7.7% from 2019 to 2026, when it will reach $61.6bn.
In the nascent cell-cultured human milk sector, Pure Mammary Factors believes it can capture 50% of all spend, by being first to market. “Pure is poised to dominate this emerging field from two major phases of business development,” we were told.
Business strategy
To begin with, the start-up will help established infant nutrition businesses ‘humanize’ their own bovine infant formula products.
“Formula is a big business, a competitive business, [and will be] dominated by whoever has the most humanized products on the market,” said Giuliano.
One litre of Pure’s human milk is capable of humanizing 10 distinct premium infant formulas, we were told.
“We can humanize with human milk oligosaccharides (HMOs), human lactoferrin, human lysozymes, human whey fraction, human casein, human lipids, human milk fat globules…all using one cell,” said the CEO. “This means we don’t need to compete with the cost of bovine formula.
“Our clients can spread the cost of production over 10 humanised products to shorten the path to profitability.”
Once Pure Mammary Factors has established the possibility of achieving a surplus in human milk supply, it plans to replace ‘all’ bovine formula.
“One day, our future selves may look back and slap our heads: ‘Why did we ever drink bovine formula?”
Having graduated from Mylkcubator, the start-up is now fundraising to support its growth over the next 18 months. With this investment, Pure Mammary Factors hopes to ‘lead the field’ of cell-cultured milk through to commercialisation, with revenue being generated within 12 months.