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BBy, a medtech company based in New York, has developed a spray drying method that hospitals can use to process human breast milk into a shelf-stable powder. Human breast milk is an incredibly important source of nutrition for neonates in intensive care units (NICUs). At present, human donor milk is frozen and must be defrosted prior to use in such facilities. This is highly labor intensive for staff and is very wasteful, as excess defrosted milk must be thrown away and large freezers use a lot of electricity.

The spray drying technology developed by BBy converts human breast milk into a shelf-stable dry powder that can be dissolved in water by medical staff as needed. Moreover, staff can make exactly as much reconstituted milk as needed, helping to reduce waste. The company reports that the spray drying process preserves the bioactive components in breast milk, such an antibodies.

Medgadget had the opportunity to speak with Dr. Vansh Langer, CEO at BBy, about the technology.     

Conn Hastings, Medgadget: Why is breast milk the best source of nutrition for young babies in neonatal intensive care units? What bioactive components are present in the milk and how do they aid neonate health?

Dr. Langer, BBy: It sounds almost cliché to say that “breast milk is best.” The truth is that for neonatal intensive care units, breast milk is critical. Its unique concoction of nutrients (water, proteins, carbs, fats, minerals and vitamins) can literally mean the difference between life and death for a child.

To give a quick example, our team recently worked with a baby who was born 16 weeks premature. This child had an underdeveloped stomach, so there was no way that it could digest infant formula. (In comparison to formula, breast milk is much easier to digest). We fed the baby our company’s powdered breast milk in diluted form through a tube that went down the baby’s nose all the way to the intestine (nasopharyngeal), bypassing the stomach. I am thrilled to say that today this child is four months old with a fully-formed stomach, and thriving!

Breast milk is not only nutrient-rich, it also provides antibodies (proteins) that help babies fight off infections. A couple of examples of these proteins include lactoferrin and secretory IgA that help protect against infections, both viral and bacterial.

Again, this sounds cliché until you experience it firsthand in the NICU. I did my medical intern year at the University of Chicago, and there was one experience in the NICU that really drove this aspect of breast milk home for me. A group of young babies who had just traveled from Vietnam came in, with their adoptive parents. All the babies were sick with infections. Obviously, adoptive parents cannot provide breast milk to their infants.

Sadly, five of the babies passed away in the NICU, but one little girl was still holding on. Heartbreakingly, her adoptive parents were told to hold her one last time because she wasn’t expected to make it through the night. I happened to see a mom that I knew at the clinic; I knew she was nursing a baby, and as a medical intern I just went up and asked her if she would be willing to give us some of her breast milk to save a dying child? Of course she said yes. We fed the baby this breast milk slowly through the night, and I am delighted to say that she not only pulled through, this child is eight or nine years old today.

Even though breast milk is best for NICU infants, a 2020 CDC report said that 13% of U.S. hospital NICUs don’t have stocks of donated breast milk. Clearly this is an equity issue as breast milk is needed to give every sick child the best chance of health and survival.

Medgadget: Please give us an overview of the current approaches used to store and deploy donor breast milk in healthcare facilities. What are the limitations of these procedures?

Dr. Langer: The way storing and deploying donated human milk works in healthcare facilities today is that first, mothers nursing infants who pump more breast milk than they need can go through a screening process that allows them to bring their extra milk to the NICU. They usually pack the milk in a cooler with ice packs, (assuming they have the time and the resources to make the trip!)

Neonatal intensive care units (NICUs) store this donated breast milk in large freezers, ideally for no more than six to 12 months according to CDC guidelines. When it’s time to feed the babies, the donated breast milk is carefully defrosted in small batches by NICU nurses, where it can be refrigerated for up to 48 hours.

In my experience in a NICU, three out of 35 NICU nurses would spend their entire shift just defrosting milk so that the other nurses could do the feeding. They always had to defrost more milk than they needed, and whatever a baby didn’t drink was thrown away. It’s a waste of nurses’ time, as well as human milk–both of which are extremely valuable.

Many people wonder, why is human milk so challenging to preserve? Obviously we’re used to seeing cow’s milk sold at the grocery store, including powdered milks and creamers. Ultra-high temperature (UHT) milk is shelf-stable and doesn’t need to be refrigerated (if unopened). The problem is that when you treat human milk in these same ways, the essential immunological proteins break down. You’re left with something that is no better than a very expensive and hard-to-obtain baby formula, which isn’t the goal.

Medgadget: Please give us an overview of the BBy condenser technology, and how it works. How does the technology provide convenience for healthcare staff?

Dr. Langer: The BBy condenser is essentially a spray dryer. The result is very similar to the cheese powder on Cheetos or cheese puffs. What happens is you take the liquid milk, put it in a vacuum, and then use heat to remove the water.

To avoid “sterilizing” the milk (and to preserve the important bioactive components that make breast milk what it is), at BBy we use a laser and an algorithm to keep the breast milk in what we call the “bio-retentive zone.” Basically, the laser maps out the flow rate and the temperature and the weight of the product until it is reduced to a shelf-stable powder.

This entire process is incredibly convenient for hospital staff. From start to finish: every two weeks, BBy technicians pick up frozen donated breast milk from the hospital. We bring it to our regional facilities and convert it into human milk powder. We then deliver the powder in aluminum packets back to the NICUs, where the packets can stay on the shelf (with no refrigeration!) for up to six months.

Feeding the powdered milk to a baby is also very simple; all that nurses have to do is mix the powder with a corresponding amount of water.

Our own estimates would suggest hospitals in the United States spend $12 billion annually on obtaining and managing breast milk. A large portion of that is labor and electricity.

The wonderful thing about this innovation is that research shows that ultimately, babies who get fed breast milk will spend less time in the NICU. It’s a win all around.

Medgadget: How does the condensed breast milk compare with fresh or frozen breast milk in terms of its nutritional value and other bioactive components?

Dr. Langer: BBy has done extensive research to compare our self-stable powder with both fresh and frozen breast milk. Based on our testing, BBy has a near 1:1 retention of both IgA and IgG, the building blocks of cell immunity, compared to frozen or fresh breast milk. This means that BBy’s powdered breast milk is able to provide all the same benefits as breast milk in its other forms.

Medgadget: How do you screen donor milk to detect pathogens and ensure safety?

Dr. Langer: It’s true that donated breast milk obtained from the hospital is pre-screened and considered safe, however it was very important that our team also verify that no infections or contaminants were present in the milk that we condensed.

Our condensing process has been proven to denature viral infections such as hepatitis, COVID-19 and HIV among others.

In order to detect pathogens and ensure safety, we performed several tests on our milk product. For a very specific example, one of our tests was to look for hemolytic activity (or the destruction of red blood cells) signifying the presence of an infection. In a culture medium rich with erythrocytes (red blood cells), we determined that none of the lactic acid bacteria from the human milk presented hemolysis (red blood cells being destroyed).

For anyone interested in learning more about this study, you can read our published results on the NIH website, “In vivo assessment and characterization of lactic acid bacteria with probiotic profile isolated from human milk powder,” Nutr Hosp. 2021 Feb 23;38(1):152-160. doi: 10.20960/nh.03335.

Other tests we’ve conducted include lactoferrin tests, fatty acid retention tests, and in vivo studies in mice, all suggesting that the milk we provide is safe.

Medgadget: Where is the technology in use at present? Do you intend to market the condensed breast milk alone, or also the condenser technology?

Dr. Langer: Today, BBy has partnered with 17 different hospitals, including large research hospitals in Massachusetts, Connecticut and Texas. We plan to expand our services to even more regional locations in the future.

One other idea we are working on is a self-service kiosk that would enable parents to process their own breast milk to powder for easier storage. Few families have the freezer space at home to store large quantities of breast milk, and this would make feedings much easier for everyone involved.

Other projects are in the works as well, the goal being to provide access to breast milk to as many infants as we possibly can.

Link: BBy homepage…

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