Scott Eaker is the chief operations officer at Prolacta Bioscience, responsible for operations, quality, regulatory affairs, and supply chain. Prior to Prolacta, Eaker worked at Baxter Healthcare, overseeing the development and deployment of standardized quality systems across multiple biologic and medical device manufacturing facilities in the U.S. and Europe.
The full potential of human milk has yet to be realized. Speaking of Human Milk provides healthcare professionals with information on the latest science and clinical research. Each episode features an interview with a thought leader passionate about uncovering the unknown potential of human milk or better understanding the science of neonatal nutrition.
In addition to hosting Speaking of Human Milk, Keli Hawthorne is the director for clinical research for the Department of Pediatrics at the University of Texas Austin, Dell Medical School. In her current role, she trains faculty and staff on effectively executing high-quality protocols for research. She has authored more than 40 peer-reviewed publications on neonatal nutrition.
Keli Hawthorne (KH): Hi y’all, welcome to Speaking of Human Milk, where we give you bitesize episodes on the latest science and innovation surrounding human milk. This podcast is brought to you by Prolacta Bioscience, a company dedicated to Advancing the Science of Human Milk. I’m your host Registered Dietitian Keli Hawthorne.
Today, we will be discussing what makes Prolacta unique in its dedication to safety and quality of its human milk-based neonatal products. Mr. Eaker is the Chief Operations Officer at Prolacta. Prior to working at Prolacta, Mr Eaker worked at Baxter where he was responsible for developing and deploying standardized quality systems across multiple biologic and medical device manufacturing facilities in the US and in Europe. Thank you for joining us today, Scott!
Scott Eaker (SE): Yes, its my pleasure.
KH: To start with, what sets Prolacta apart in terms of donor milk safety compared to other milk banks? SE: The safety of Prolacta’s products begins with our donor selection and qualification process. Before someone can qualify to donate their breast milk they have to have undergo a medical and social screening. The donor is also required to obtain written confirmation of health status from her doctor and her baby’s doctor to ensure that the baby is receiving breast milk and to verify any medications the donor may be taking.
Once the donor passes these steps, a phlebotomist is sent to their home where a blood sample is taken to test for diseases such as HIV-1 & 2, HTLV 1 & 2, HBV, HCV, Syphilis. We also take a sample of the donor’s cheek cells to create a genetic profile of the donor. This is done so that we can verify that the milk received matches the qualified donor – it’s called DNA matching and we are the only one in the human milk industry to take this extra step. KH: That’s great. So you aren’t required by the FDA or any outside agency to perform this extra step of DNA matching, but you do it– what was the impetus to take this extra step?
SE: Many of the original employees at Prolacta, including myself, came from the plasma industry. Because you’re working with blood, the plasma industry adheres to a very high level of safety standards to ensure that the plasma is free of disease and contamination. One key requirement is to be able to trace each donation from the arm of the plasma donor to the arm of the patient receiving the product. Like blood, human milk is also a biologic and because our products are being used by the most fragile infants whose immune systems are not finished developing we really wanted to make sure that we could provide the safest and best human milk products for these babies and so we modelled our safety standards after the plasma industry. Using DNA matching, we can ensure we have traceability from the donor all the way to the baby receiving our products.
KH: So you can verify that the milk received is from the qualified donor through DNA matching and you also test the donor herself for diseases but how do you ensure that the milk received doesn’t still have some traces of a disease or virus?
SE: We directly test each milk donation for the nucleic acid of HIV 1 & 2, HTLV 1 & II, HBV, HCV, syphilis, Zika virus and tuberculosis. We also directly test all donated milk for drugs of abuse including nicotine.
KH: I know that online milk sharing like through Facebook groups where moms buy someone else’s milk online is cropping up everywhere. And one of the major concerns is that the milk is sold by volume so there’s a temptation to top off the breast milk with cow’s milk, water, or infant formula. How does Prolacta ensure that the donated milk you have doesn’t have that problem?
SE: Each donation we receive is tested for adulteration, which includes dilution.
KH: What other safety precautions does Prolacta take in the manufacturing of its donor human milk products?
SE: Well we also perform microbiologic testing throughout multiple points in the manufacturing process where we test for things such as total aerobic bacterial count, Bacillus cereus, E. coli and other coliforms, Salmonella, Pseudomonas, Staph aureus, yeast and mold. Also, we recently built a second facility near by our original one. One facility is where our raw donor milk is first received and where the milk is tested for adulteration, drugs of abuse, disease causing organisms and verified through DNA matching. Only milk that has passed these tests will be sent to our second facility. This provides an extra measure of safety by ensuring that only “approved” milk is processed and pasteurized for use in our final products.
KH: What about medications? For example, what if a mom is sick and needs short-term antibiotics? Is this milk used?
SE: Prolacta has developed an extensive database of prescription and over-the-counter drugs, as well as vitamins and supplements, health conditions and travel restrictions that we use to determine if milk is acceptable for donation. Our milk bank staff work with donors to make sure that any milk that can’t be donated due to, for example, antibiotic use will be segregated by the donor. The compensated donor can still send that milk in, but it needs to be placed in a “yellow” bag separate from the milk that is good for donation. Donors that choose to be remunerated for their time and effort will receive the same remuneration for the milk in the yellow bag, however, because this milk is typically fine for a healthy term baby, most mothers decide to keep this milk for their own use. Donors who choose to donate to our charity milk bank are instructed not to send in the segregated milk. That “yellow bag” milk may be used for research and development purposes, but it cannot be given to the fragile, preterm infants.
KH: I’m going to ask you the question that everybody is asking right now – what about the coronavirus. What do we know about the transmission of the virus through breastmilk.
SE: A couple of things that are very positive in that area. Number one, the data that has been generated so far does not seem to indicate that a mom who has coronavirus will be passing that coronavirus in her milk. Now those are small samples of moms that they looked at but that’s definitely promising data. I think more importantly is what we know about pasteurization and coronavirus. Fortunately, coronavirus is a reasonably heat-sensitive virus and so there is very good data on the temperatures that you need to achieve in order to inactivate coronavirus and pasteurization is a very good way to inactive coronavirus. Not only s there published out there but we’ve actually done our own internal validation of pasteurization against model viruses in the same class of virus as coronavirus and pasteurization is very effective against coronavirus.
KH: That’s a great update about the safety of the donor human milk. Now, what about the quality. What process do you have in place to make sure that each fortifier, ready to feed, cream product has standardized nutrient amounts?
SE: The nutrient content of the feedings for preterm infants is very important. That’s why we carefully measure things like protein and calories at many different points using both rapid and traditional chemistry methods. We then target a specific concentration of key nutrients using processes like centrifugal separation and ultrafiltration. We also utilize as much of the donated milk as possible. For example, we are able to use excess cream from our fortifier manufacturing to standardize the calories in Prolacta HM to a minimum of 20 Cal/oz. This means that doctors, nurses and dieticians can deliver the precise levels of nutrition to get the best outcomes.
KH: There is a lot of time and effort involved in pumping and storing breastmilk. Does Prolacta compensate women for this when they donate milk?
SE: Because of the fragile nature of the babies receiving our products, we require our donors to follow a lot of rules about things like how they wash and sanitize their pumps or how they store and ship their donations. Also, many of our donors fall into the high-producer category. That means that they are pumping every few hours around the clock. It’s really a lot of work! That’s one of the reasons that we remunerate our donors for their time and effort.
What triggered us to look at remunerating donors was something that we noticed back in 2010-2011. We started to see mom’s going online to buy milk to supplement their own supply. It didn’t take long before sites dedicated to connecting mom’s selling milk to mom’s buying milk appeared. There are a lot of reasons why that is a bad idea, and recent publications have confirmed some of these risks. But we wondered whether remunerating donors for their time and effort could be done safely. We spent several years identifying risks with remunerating donors and finding solutions to mitigate those risks. The yellow bag process mentioned above is a good example of a risk mitigation.
KH: Thanks so much for helping our listeners understand more about the quality and safety issues that Prolacta values. Is there anything else you’d like to make sure our listeners know?
SE: We are very proud of our testing and manufacturing process, so much so that we give several tours of month to healthcare providers, donors, and parents at our two facilities.
KH: Thanks again Scott for this very informative discussion on the quality and safety of donor human milk. For our listeners, links to information discussed will be available in the show notes and we look forward to bringing you future topics on the science of human milk.