108Labs is pioneering mammary cell agriculture lab that produces human milk molecules and secretory antibodies to supplement infant and adult nutrition, in developing countries and beyond. In this interview, co-founder and CEO Shayne Guiliano describes this revolutionary technology and its potential impact on public health.
Please describe the story behind the company: What sparked the idea, and how has it evolved so far?
My background is in organic chemistry and software development. I’ve been running independent software and biotechnology projects for 20 years now. I became interested in cellular agriculture about eight years ago, with the notion that even though there are a lot of amazing cells in the world, very few of them are utilized for biotechnology.
Our initial intention in the summer of 2013 was to experiment with meat and leather tissue reproduction. On September 11, 2013, I acquired a lab space in Research Triangle Park, NC, and started planning what reagents to buy and cells to play with. Later that day, while discussing what other types of cells we should request from the slaughterhouse for meat and leather, we pondered what else could we make with cow cells? The obvious answer was milk, and the basic question was, could we milk cells instead of milking cows?
The basics of working with mammary cells have been established for decades, but nobody had tried to produce milk from cells at a scalable level for food production. That became our primary focus.
The basic idea that we coined and which led us to this vision for biotechnology of milk production, Cellufacturing, refers to the utilization of cells as manufacturing platforms. We figured that there must be a way to separate any cell from any organism and utilize it as a factory.
I call it a collection of milk molecules instead of milk because milk comes from an organism and contains elements that our cells don’t produce. Fresh mammalian milk also has a microbiome while ours is produced microbe-free. That said, we discovered that most of the important milk molecules made by mammary cells in a person can be made in a bioreactor. Also, the lack of a microbiome in our milk molecules means we don’t have to pasteurize and degrade the molecules before packaging them in sterile containers to maintain maximum bioactivity, from the bioreactor to the mouth.
Around 2016, we began thinking bigger in terms of 3D cell culture and went for a major proof of concept in late 2019. In early 2020, I also discovered how to make secretory antibodies, which was the final piece of the puzzle to replicate the major bioactive benefits of mother’s milk. Our proprietary antibody production is novel biotechnology and should compete with classic antibody production biotechnologies on quality and cost, much less the world’s first therapeutic whole-human secretory IgA. Combined with human milk molecules, we can now approach the immunological benefits of human milk in a brand new way, starting with the antibodies and moving into major milk proteins, lipids, complex sugars, nucleotides, and cytokines that already have a well-studied impact on infant health – and likely to also impact adult health one day.
Maybe, if we had started with millions of dollars, we could have invested more in the research and preparation before performing our big proof of concept experiment. But, as we were completely self-funded, we had to skip many steps to go for scalable production and almost guess what the ideal conditions would be. We just went for it with the last of our savings, and it worked!
The hypothesis was always that if you can create the right conditions to keep enough mammary cells happy and figure out how to turn their levers and knobs, they would produce milk.
We didn’t set out to build a business, we were just pursuing a scientific curiosity, but once the list of milk molecules we created was in hand, we immediately saw the potential impact. That was a long journey but things have accelerated since then as we started attracting capital and hiring more scientists.
To make a long story short, we discovered how to make oral immunoglobulins and human milk molecules, special molecules created by 300 million years of evolution. They can be personalized or commoditized into an infant formula or other therapeutic substances and may have a big impact on human health one day.
With so many alternative options, why should parents choose your product?
It’s hard to move the needle in infant nutrition because bovine milk is already well formulated and highly regulated to simulate the basic nutritional profile of human milk.
In a world where there’s not enough mother’s milk for all babies, bovine milk does a good job of providing a basic nutritional foundation for human life, but bovine formula lacks the immunological benefits of mothers’ milk.
Infant formulas have a foundational baseline of growth that they need to adhere to during infant nutritional trials, but they are not tested for antimicrobial benefits at all. Bovine formulas have been striving to become human-like because raw bovine milk is actually toxic for newborns and lacks some basic human needs like sufficient tryptophan levels. For this reason, bovine formulas are heavily processed and regulated. The nutritional makeup of bovine milk is sufficient but still problematic because it has evolved for bovine, not humans. So, the protein content is higher than normal, which isn’t ideal, but better than not having enough tryptophan.
Bovine formula manufacturers have to prove that their product is suitable for human infants, whereas for us, that’s just our starting point. We know we already have the molecules best suited for human infant nutrition. I think that’s a fundamental advantage.
Even donor milk is not neutralizing pathogens the same way as mother’s milk because any milk with a microbiome should be pasteurized before consumption – which degrades its antimicrobial properties. That donor milk market is almost completely unregulated, so we have no way of knowing what’s really in any given donor milk sample.
Our milk molecules go beyond donor milk and bovine formula into something closer to Mother’s milk. We can now replicate the nutritional and antimicrobial profile of a mother’s milk, including the immunological spectrum of her immune memory reflected in her wild-type antibodies, and her resistance against environmental pathogens.
From the consumer perspective, what are the differences between commercialized and personalized human milk?
Even though our milk biotechnology is personalizable, I don’t think personalization will be the most important feature when it comes to nutrition. As long as all the functional nutritional molecules are present at reasonable ratios, it doesn’t matter who’s cell is making the proteins. Any single cell donor might be deficient in a key protein. The ratio of the proteins may vary based on who is donating them and what time of day they are being made, but shifting the ratio of proteins is not going to have a very big impact on the final nutritional profile.
However, reflecting a mother’s immune system through antibody personalization is likely to produce antibodies that are effective for a baby in the environment where they are going to spend the first months of their lives. Personalization may matter to the development stage of the baby. A preterm is going to have different needs than a full-term newborn, and then six months in, the baby will already be making their own immunoglobulins. Until they are six months old, babies are highly susceptible to pathogens. So, personalization of antibody production is likely more important for immunological benefit than for nutritional benefits.
A similar situation happens with bone marrow transplants who lose their immune memory. When you don’t have antibody immune memory, you are vulnerable even to the most basic environmental pathogens.
Milk molecules have amazing anti-microbial properties, especially when combined with antibodies. There are broadly neutralizing antibodies that we can develop to add to all the formulations, whether personalized or commercial, to have the biggest impact on reducing the risk of pathogen infection in newborns.
There is some amazing data out there regarding the bioactivity of oral immunoglobulins in mothers’ milk. Currently, there’s nothing comparable to mother’s milk on the market. We think we’ll become the first infant formula comparable to mothers’ milk.
I also think there’s some level of emotional attachment to it, potentially, from the parent’s perspective, so personalized mammary cell agriculture may still matter to consumers.
Here’s a thought experiment: men and women can produce milk, so potentially, a same-sex couple of two men can use their own cells to feed their child. That may sound like sci-fi, but this is basically what I’m doing in my lab right now with primary cells.
We can give parents the feeling that they have contributed a piece of themselves to sustain the health of their child, even if it didn’t involve nursing from a breast or pumping around the clock. I think that appeals to all people, it just may not move the needle much in terms of actual nutritional benefit compared to commercially formulated human milk molecules.
What do you think is your potential impact on public health?
The biggest impact we can have is bridging the immunological gap between mother’s milk and bovine or donor milk in preterm newborns. Babies born anywhere between week 28 to week 38 are very vulnerable to adverse outcomes like sepsis and Necrotizing Enterocolitis. So, oral immunoglobulins and non-pasteurized human milk molecules may significantly improve the immunological protection compared to donor milk, accelerate energy consumption, and have all the special properties of unpasteurized mother’s milk.
Additionally, we can supplement donor milk with the same non-pasteurized, fully bioactive milk molecules that already align with the standard of care in preterm infants. We can further bridge that gap for mothers by adding neutralizing antibodies to protect babies at this critical stage of life.
It was only around the 1960s and 70s that neonatal science was invented. Around the 1990s, it became clear that any baby born before the 32nd week should be on an exclusive human milk diet. If the mother can’t nurse, those milk molecules will come primarily from donor milk.
The standard of care now is donor milk plus donor extracts, in other words, concentrated milk molecules that supplement donor milk. Donor extracts have proven that if you concentrate some of those molecules, you get an energy-dense substance that these tiny stomachs with extremely fragile epithelial layers do better with.
There is no approved substance for early term infants to prevent outcomes like late-onset sepsis and necrotizing enterocolitis. Developmental brain and heart diseases are pretty common in early-term infants, too. It’s a race against time to absorb calories and prevent pathogen infection.
By supplementing that immunological gap that is missing from pasteurized donor milk, I believe we can move preterm feeding closer to mothers’ milk, and that’s the biggest impact we can have in saving lives.
According to WHO, access to immunoglobulins between 0-6 months can save 2,000 babies today from pathogen infection. Another 2 million are in danger of preterm adverse outcomes worldwide, especially in underdeveloped nations. All of these segments of early life are very susceptible to immunological and environmental pathogens, so the earlier in gestation you look, the greater the impact our molecules can have.
There are places in the world with a 90% mortality rate in early term infants. They might have a hospital nearby, but it wouldn’t have the type of sterile environment needed to protect early-term babies. Oral immunoglobulins and fully bioactive human milk molecules may have a big impact on those disadvantaged communities.
In the US, we spend about $5 billion per year on preterm intervention in cases of adverse outcomes, yet we still lose about 1000 babies every year, and another 5,000-6,000 are at risk of lifelong disability. Without access to mother’s milk, every baby is at risk of falling into that category, from the earliest preterm up until six months. Therefore, our focus is on bridging the immunological gap between mother’s milk and donor or bovine milk.
Mother’s milk will always be the gold standard and we’re not here to replace it, there’s just not enough of it in the world. About 20% of mothers can’t nurse because they have immunological deficiencies, a medical condition, or some other reason, and even then, few can sustain nursing for 6 months. They might be the CEO of a company and practically can’t do it because it would disrupt their lives too much. We believe that all parents should have choices that don’t compromise the health of their baby.
I think it’s unfair that today, mothers carry this burden exclusively. There’s a lot of guilt associated with breastfeeding or not breastfeeding, and if a child has an adverse outcome, that’s pinned on the mother, whether she is breastfeeding or not.
We’re developing a well-regulated option with antimicrobial benefits that you can’t get from donor milk or extracts. It’s not a quick win opportunity like some of the other competitors in the field. It’s a longer, harder path to take to have the biggest health impact and save the most babies.
Could Colostrupedics™ substitute cow milk?
From a commodity perspective, human milk molecules are going to have a big impact one day. People have been afraid to think about human milk as a product because the commercialization of farmed human milk is unethical. After all, we don’t want to end up with human milking farms. But if you take the cell out of the human and turn it into a factory, you end up with ethically sourced milk molecules.
So far, there’s never been a source of fully human milk molecules that didn’t come from a woman, so this negative connotation of human milk was inevitable. If you break out of the normal conversation of whether or not mothers should nurse and what’s better, the only barrier to human milk replacing bovine milk is cost. The day we achieve cost parity, it’s just a matter of time before bovine gets replaced.
Human milk is always going to be better for humans because it evolved for us. It has the perfect amino acid pattern and bioactivity, without the allergen risk of non-human milk.
Of course, there are many reasons to move away from bovine milk: its contribution to climate change, animal cruelty, and other emotional reasons that can help the cultural acceptance of human milk.
When we have enough therapeutic proof that human milk is the best single substance humans can consume, we’ll be able to produce enough milk to feed not just babies, but also people suffering from cancer who need passive immunity. It may take 20 years until we have just as much access to human milk as we do to bovine, but I think it’s inevitable.
How do you deal with prejudice associated with the commercialization of human milk?
The debate about breast milk has almost become political. That’s why I don’t even want to call it milk because that’s not really the debate that I care about. It’s really about who we can help and which lives can be saved.
Consumers may have prejudice against human milk today, but doctors tend to choose and recommend whatever leads to the best health outcome. I’m not too worried about the uptake in the short and medium-term because I think that, as long as we’re pursuing a better health outcome than bovine can provide, it doesn’t matter where it comes from. If a biosynthetic human formula can save lives, it is going to be adopted, but we have to take care in how we talk about it. I shy away from calling it milk. I prefer the term milk molecules because it’s a better way to navigate the discussion and give mothers the respect they deserve.