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Human milk access and safety webinar

Speaker:

Scott Eaker, Prolacta Chief Operations Officer

Scott Eaker joined Prolacta in 2007 and currently serves as our COO. Scott is responsible for our manufacturing, milk resourcing, quality, supply chain and regulatory affairs. He has over 20 years of experience in the bioscience and nutrition sectors. Scott began his career in the microbiology laboratory at Baxter’s first recombinant factor-VIII manufacturing facility. He supported the start-up of the bulk manufacturing and fill/finish operations, implemented numerous test protocols, led failure investigations, and rapidly became a supervisor of laboratory operations.

Scott also held a role serving as the subject matter expert in the areas of microbiology and aseptic processing for Baxter. In this position he was responsible for developing and deploying standardized quality systems across multiple biologic and medical device manufacturing facilities in the US and Europe. Scott was also responsible for quality in the plasma fractionation area and ultimately served as director of quality technical support for the bioscience division at Baxter.

Scott received a bachelor of science degree in microbiology from the University of California at Davis.


TRANSCRIPT

Scott Eaker:

Human milk has tremendous benefits for babies. Particularly those babies in the NICU who are born at very low birth weight, and the issues that go along with that.

And the clinical studies are telling us that it's more than just nutrition. Nutrition really is medicine for these infants. There are many clinical studies, over 35, that show that an exclusive human milk diet in these babies drives improvements in comorbidities. Things that you would expect, NEC and surgical NEC, but also things that you might not expect, like even BPD and ROP improving in these babies that receive exclusive human milk. But the current definition of milk and the products made from human milk is not that they are medicines, but that they are only foods.

So, as a food, there are many nutritional aspects of human milk. But like blood and plasma and other biologics, this food is not without risk. And, we know that many things from biological agents such as viruses and bacteria, to molecular entities such as drugs, can be transmitted through breastmilk to these babies, and that is a risk.

Coming from a background in plasma, we really look at dealing with human milk as a multifactorial approach, and that means that we have to be thinking about not only what do we know today about the risks of human milk, but what do we anticipate might be the risks in the future? And we have to build systems that anticipate and deal with those risks. And that means that we have to be very forward-thinking, mainly because there are no national minimal requirements and standards that have been put out there that are in place for every milk bank and every manufacturer of human milk-based products.

Each milk bank is developing its own and following its own set of protocols to ensure the safety of the products. And, that is really problematic when you start to look at the growth of the industry as it's occurring today.

There are a number of different ways that we approach safety. We start with the screening of donors, and then we test the milk as the process goes along.

So, what's the difference here between screening and testing? Well, you can see here, there are a number of things that fall into the category of screening. We do a screening of our donors and we have a questionnaire that they fill out, that is truly just a screening process. It's asking a set of questions and getting answers from the donor, and that is a one-time or an infrequent process that we're going through.

Testing, on the other hand, indicates that you are actually interrogating the milk that you're receiving to ensure that the answers that you got from the donor during the testing process are matched by the answers you're getting. Or during the screening process, matching the answers that you're getting from the milk during the testing process. And that is what we found to be critical when you are dealing with biologics. We learned that from the plasma and blood industry.

You can certainly screen donors, and that is a very important part of the process, but it is not the be-all, end-all. You really do have to do the testing to ensure that you're getting the answers that you expect.

The distinction between screening and testing, I think is lost on many legislators. We are really trying to educate people on why this distinction is so important.

And here's one example. A screening of a donor and even testing of a donor at the beginning of their donation process might tell you what their risk is from a viral standpoint at that moment, but it doesn't tell you anything about their future risks. A donor can be free of infection at the time of screening and blood testing and become positive and seroconvert later. Without some sort of testing of the milk on an ongoing basis, you won't know whether that donor seroconverts unless you do some testing at a later date. And, there are no requirements to do that other than in a few very limited circumstances.

The other thing is that screening can help you understand what a donor's risk is with respect to their environment and their behaviors, but only to the extent that they're willing to disclose those pieces of information honestly. And that doesn't change on an ongoing basis. So, harmful chemicals, drugs, and even exposures to things like heavy metals in the environment might not be obvious, or might not be the case at the beginning of their donation journey, but that might change over time.

One example that we use, because it's really very easy for people to understand, is we screen every donor by asking them, and every milk bank screens their donors by asking, do you smoke? The answer needs to be "no." And for us, that needs to be a "no, not for the past 12 months, no use of nicotine, no smoking or anything." But what the data tells us is that it is a hard thing for some donors to maintain. And in fact, up to 40% of women who smoked prior to pregnancy but quit will relapse at some point in the first six months postpartum. When we look at the data that we've generated internally by doing an actual cotinine or nicotine test of milk, we do see that while 40% is not reflected in the numbers, some level of compliance or lack of compliance is reflected in the numbers.

And, the interesting thing always to take away from this is, we looked at it from the perspective of non-paid donors, with non-remunerated donors, and remunerated donors. There is really no statistical difference between those two populations. We see cotinine failures in both at essentially the same rate. So clearly, if we are not monitoring compliance on an ongoing basis, then there's just things that we're going to be missing, even if we're screening our donors every six months, as is the requirement of, say, for the state of New York tissue bank licensing.

And there's a lot of misconception around the risk associated with these things. We pasteurize the product. Doesn't that ultimately make the product safe? Well, in fact, pasteurization is a pretty amazing, amazingly good viral reduction and risk reduction technique, and it's used across a variety of different industries. Every drop of albumin that is produced out of human plasma is in fact pasteurized. It's pasteurized under requirements in the CFR for biologics. Very effective. Albumin is a very safe product. There has not been a transmission of the virus using albumin in decades. Many, many decades.

It's also used, as we know, in the dairy industry, and that pasteurization is one of the ways that dairies do pasteurize. And in the dairy industry, pasteurization is highly controlled and regulated. There is the pasteurized milk ordinance. That is the FDA's set of requirements for equipment process monitoring of pasteurization, and it is incredibly rigorous and very specific. So every drop of dairy milk follows that process.

And then we also have other processes that are kind of like pasteurization, like retort processing. It's really more of a sterilization. It's a high temperature, high-pressure sterilization. It falls slightly short of what we would consider sterilization like would be used for the production of surgical instruments, but it's pretty close. It produces a commercially sterile product. It also, as we know, destroys a lot of the bioactivity and bioavailability of the components of milk, but it is highly effective in pasteurization.

What none of these do is universally address small molecules and contaminants that might be in the milk. So, while there are likely some contaminants that are sensitive to heat, even at lower pasteurization temperatures, the vast majority of these molecular entities are going to make it through just fine.

A great example is THC. At these temperatures that you're going to expect to see in pasteurization, you're going to have very little effect on THC. Up to 200 degrees Celcius, then you might see a small reduction in THC coming through in the final product, but pasteurization is not a panacea. It is a great step in the process for safety, but it does not address a large number of problems.

And I'll highlight one other area that pasteurization does not deal with, and that is bacterial enterotoxins. Many of the enterotoxins produced by bacteria, such as staph, bacillus cereus, are not destroyed even in retort processing. So, if the bacteria is present and allowed to produce toxin in the milk upfront, that toxin will remain and will end up going in, fully active into the patient. These are all the things that need to be considered when we talk about human milk donations.

We talked about the regulation of dairy milk. Is human milk regulated the same way? It is not. Dairy milk has its own specific set of regulations. Human milk is regulated in a variety of different ways. At its most basic, donor milk is regulated as a food by the FDA. It's covered by the Center for Food Safety and Applied Nutrition. There are no specific regulations at the federal level for human milk, but it does, in theory, need to comply with all regulations that all other foods comply with.

For some types of human milk products, like our fortifiers, the FDA has applied a stricter standard of infant formula. Infant formula has its own set of regulations. They're still foods, but they have their own set of regulations, and they're much more strictly managed. For example, there are very strict requirements for the testing of and labeling of infant formula products. There are notification processes with the FDA before you can market a new infant formula or a modified infant formula, and we do get inspected much more frequently than your average food producer. We see the FDA, in theory, we should see them every year. In practice, they get around to us about every two years. But like clockwork, they come into our facility and audit us every two years.

And then there's another set of state-level regulations that have been in place for a while, and those are tissue bank regulations. California, Maryland, and New York do classify human milk as tissue and require that you hold a valid tissue banking license. In our case, both California and New York inspect us. California, more frequently. New York, obviously less frequently. About every five years, they show up and they do a full compliance inspection against their regulations.

So, as I said, human milk, donor milk itself, though, is just regulated as a food. That means that it has a lower level of inspection. Food manufacturers are generally not inspected on a routine basis. They are generally inspected on a for-cause basis. When there's a problem, the FDA will show up. They do not require any pre-market notification, so a new donor milk bank would not be required to notify the FDA and provide any information to the FDA beyond registering their facility as a food manufacturing facility.

So the question is, why is it that the milk that you're seeing on the left of your screen, the dairy milk going to these kids, how is it that that's more regulated than the donor milk that's going to the baby in NICU on the right side of the screen? And that's really why we're here today and why we are talking with different states about the level of regulation of human milk.

What we've been able to do is to work with different states like Arkansas, New Jersey, and Pennsylvania to put in place common-sense law that says we are at least going to require that the donor milk and human milk-based products in our state that are given to fragile NICU babies meet some minimum standard of safety and purity. And so as you can see here, there are six states now that have some level of regulation, some level of a law in place, and that are actually putting licensing requirements in place and writing regulations to oversee donor milk banks and the milk that's coming into their states. And there are four additional states that are in the process of writing that legislation and are talking with constituents, talking with stakeholders about what that should look like.

As we look at the variety of different ways that the states are regulating human milk, what really is the best approach? Is it to go all the way to calling it a tissue and regulate it just like you would tissue banks that exist in your states? Ultimately, we believe that the best approach is for states to put in common-sense legislation that says we are going to provide state-level oversight, and we are going to provide a set of minimum requirements that the milk banks must meet. And those minimum requirements should address the broad concerns around the safety of the milk provided to these infants.

And, we are getting good response as we talk to state legislatures. As you can see here, you look at the timeline from of the last 20 years of the human milk industry, starting with when we were established and there were really just a handful of donor milk banks in the U.S., until today, where we have well over 25 non-profit milk banks, and we have four different entities, for-profit entities that are in various stages of producing donor milk of a variety of types, or even starting to talk about producing human milk fortifiers and those types of products.

We know, as an industry grows, and the faster it grows, the more risk there is to the patient if there's not appropriate legislation in place. And just to give you an idea, of what that looks like in terms of total volume, this is what HMBANA has put out in terms of the growth of their milk banks in the number of ounces that they are producing. So, that's pretty amazing growth that you're seeing on the donor milk side. And on the one hand, that is fantastic for babies. That means that more hospitals, more preterm infants have human milk available to them. But on the other side, it means that there are more milk banks in play. More people are getting interested in this because they see the volumes and that there is a demand, and that's where we really need to begin managing the risks.