A Memoir of a Mother’s Determination and Her Micro Preemie’s Struggle to Beat the Odds
I recently had the pleasure of being part of the Prolacta Bioscience Education Day and Facility Tour in City of Industry, CA. in late January of this year. Many of the participants flew in from various locations across the United States and the group was made of up assorted careers and stakeholders- all of which have an interest in helping our most fragile patients- premature babies.
As most of the great ideas of the past began, the idea of Prolacta Bioscience began with a few like-minded and passionate people sitting around a dining room table discussing ways to help premature babies thrive.
They had a vision and were able to take their dream and turn it into a reality. This reality is something that many parents across the country are thankful for today.
Prolacta Bioscience, Inc. is the pioneer in standardized human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, they believe infant nutritional products should be human milk-based. As a privately held, for-profit and scientifically driven company, committed to improving premature infant nutrition, Prolacta is using human milk to change the standard of care in the NICU.
In premature infants, breast milk feeding is associated with reduced infections and inflammatory diseases such as Necrotizing enterocolitis (NEC). NEC is a very serious disease where the intestinal tissue is injured or begins to die off and then a perforation occurs that allows bacteria and waste products to enter a baby’s blood stream. This very often leads to surgery requiring sections of the bowel to be removed and in many cases (about 40%) can lead to death. Human milk holds the power to reduce many of these cases.
For the first time in over six years, the American Academy of Pediatrics (AAP) has issued a policy statement regarding breastfeeding and the use of human milk. Their recommendations include a reaffirmation of exclusive breastfeeding for the first six months; use of human milk for all preterm infants, whether mother’s own milk or pasteurized donor human milk; and human milk should be fortified, with protein, minerals, and vitamins to ensure optimal nutrient intake for infants weighing less than 1500 grams at birth.
Prolacta Bioscience takes these recommendations very seriously.
They are the only company that provides standardized donor human milk fortified to a minimum of 20 Cal/fl oz and provides an average of 1.1 g protein/100ml. Moreover, they are they are the only company that provides a human milk-based fortifier essential for these tiny preemies. Their breast milk has a two-year shelf life supported by real-time stability studies. They also offer the only donor-matching program that tests for common drugs of abuse, nicotine or other “adulterations”. They screen all milk for HIV-1, HCV and HBV by polymerase chain reaction (PCR).
Here is the kicker- the type of analysis/testing that puts Prolacta Bioscience ahead of their competitors- far ahead!
Wait for it…
They store the DNA of all breast milk donors and are able to guarantee that mothers who were removed from the donor list for various reasons (drugs, alcohol, and other adulterations) cannot simply “try again” at a later date and donate milk in the future. Once you are removed from the donor program you cannot donate again and no one else can ever donate your milk under another name because they can match it to your specific forensic DNA profile. This protects all recipients from receiving human milk that was donated by someone who had unfit milk in the past.
You may be wondering why I attended the Prolacta Bioscience Clinical Discussion and Facility Tour.
First, I am a member of the Preemie Parent Alliance (PPA for short). Our Organization is dedicated to representing the needs and best interests of preemie families in all facets of healthcare policy, care guidelines, advocacy, education and family support. As a national network we are establishing a unified parent voice to advocate for infants, who cannot speak for themselves, and their families. PPA is a proud supporter of Prolacta Bioscience and their mission to make human milk available to all premature babies.
Second, I am a member of The Morgan Leary Vaughan Fund’s Board of Directors. The Morgan Leary Vaughan Fund (Morgan’s Fund) is an all-volunteer, public charity dedicated to Necrotizing Enterocolitis (NEC). Our mission is to promote public awareness about NEC and the potentially devastating effects it can have on preemies and their families, and to advance research to prevent, diagnose, treat, and ultimately cure NEC. I am a proud member of Morgan’s Fund and our mission fits in quite well with the goals of Prolacta Bioscience. We look forward to supporting all of Prolacta’s future research.
There is one more reason that I became interested in what Prolacta is doing. I have been teaching the secondary sciences at my local high school for over 18 years and all of this stuff is just plain fascinating!
Our day began with a delicious breakfast where Dr. Martin Lee (VP, Clinical Research and Development) and Dr. Victoria Niklas (Chief Medical and Scientific Officer) spoke to us about how Prolacta started, what they do, products they offer, and what they have accomplished since inception.
Right away I felt a vibe that you don’t often feel when visiting an industrial corporation. Everyone loves their job! From the people that spoke- to the people you passed in the hallways or chatted with in the labs- they all enjoy working at Prolacta and believe in what they do.
There is something to that.
Many Prolacta employees have a personal connection to a premature baby and that seems to motivate them even more. I can’t think of a better group of people to work on ways to improve the standard of care in the NICU, can you?
After our breakfast we were schooled on just how much effort goes into the guaranteeing the quality and safety of all Prolacta products. Scott Eaker (VP and Director of Quality and Regulatory Affairs) gave an impressive presentation on how they operate.
Next we learned about how the donor milk program works during a presentation by Raoqi Dulman (Director of Business Development). Since I already explained how detailed their milk donor screening process is, I will not do it again- but I will say that the processes they have in place puts Prolacta’s donor milk ahead of any other donor milk program out there, as far as quality and safety.
After after the presentations were done we were broken up into two groups and escorted around the facility. Joe Fournell (VP of Operations) was the leader of my tour. He was a great guide and he also has a connection to a premature birth.
The building is so clean that you could eat off their floors, although you are not allowed to eat in any other room but the conference room, for sanitary purposes. Lol!
Prolacta even has their own reverse osmosis water filtration system that they use just to clean any instruments that their products touch. They don’t add any water to their breast milk but they wanted to be sure everything is sanitary so they built their own water filtration system to ensure it. That’s pretty impressive!
The labs themselves far surpass any other science lab I have been to- and I have been to many as a career science teacher who takes a chemical engineering class each summer in various pharmaceutical companies on the east coast. The procedures in place and methods they use to guarantee that their donated breast milk is not only free from bacteria and viruses, but is also completely unsullied by anything from the lab, is downright amazing!
All employees who handle breast milk or other materials used in their products must be fully covered in gowns, gloves and masks. They look more like Hazmat inspectors than scientists working on human milk, but you can be sure that nothing is getting past those suits.
All labs are kept at a very cold temperature so that the milk remains stable. Because of this, many of the employees walking around in the lab areas are wearing snowsuits and winter gloves under their gowns. This is to ensure the quality of all of their human milk products.
What I also thought was incredible was how the coolers of breast milk are handled once they arrive. Each cooler is put in a window that is sealed on both sides and only one side can be opened at a time. This ensures that any outside dust or particles (but I did not see ANY- ANYWHERE!) cannot get sucked into the lab due to a draft or wind tunnel, and it also keeps the temperature at a constant refrigeration temperature. Once a mother’s cooler enters the lab side, a sample is taken from EACH cooler and tested for various diseases, bacteria, and viruses. EACH cooler of milk from EACH mother is also tested for opiates, tobacco, and a number of other substances that a mother could have in her system. They call this type of milk “adulterated” and they will not use ANY milk if any of those substances are found in the breast milk. I explained a lot of this earlier but it’s so impressive that I had to mention it again.
Each conference room and science lab has photos of babies hanging up and many rooms are named after babies that were successful and thrived because of using either Prolacta’s donor milk or a product made from Prolacta’s donor milk. It was beautiful to see so many success stories hanging up and I am sure that this motivates the employees each and every day.
Our tour ended with a Q & A session over lunch after a brief presentation from Scott Elster (CEO of Prolata Bioscience). He is pretty entertaining!
A shuttle took us back to our hotel where we had a few hours to rest before our networking dinner. It was nice to be able to sit and have some casual conversation with so many people who share the same goals and who feel just as much of a drive to help premature babies thrive.
Prolacta Bioscience is also participating in some very cutting edge scientific studies at the moment- looking into how human milk and it’s products can help with other diseases and disorders afflicting all types of children and not just premature babies.
One such study is in full-term babies diagnosed with single ventricle physiology (sometimes called a “single ventricle defect” or “single ventricle anomaly”). This is a disease where the babies functionally have only one heart ventricle (most of us have two). Typically these babies require corrective surgery within the first week or so of life. These babies are similar to premature babies in part because their heart condition renders them unable to take in large amounts of fluid, so feeding them sufficiently enough to allow them to grow is a challenge. This study is investigating whether the approach that has been proven successful in preemies of using a human milk-based fortifier modified to meet their particular needs will be able to deliver enough additional nutrition to allow these babies to grow and recover from their surgery faster than they currently do.
Prolacta is also conducting another exciting study in children between six months and five years old who require a bone marrow transplant. This study is testing whether the use of a human milk-based product to deliver a portion of their nutrition will have effects both on the bacterial population of their guts and on their immune systems, such that the rate of occurrence of a serious complication called graft-versus-host disease will be reduced.
I can’t wait to hear about these results and I wonder about the plethora of other medical issues that can be addressed by the science of human milk in the future. I’m sure that the scientists at Prolacta Bioscience are already brainstorming about it!
Well, I will finish with once again saying how impressed I was with Prolacta Bioscience and I feel honored that I was invited to participate in their Education Day and Facility Tour.
They even left a gift for me in my hotel room! And look at my view!
For more information on Prolacta’s cutting edge research in the field of human milk and to learn more about their donor milk program and products, please visit http://www.prolacta.com.
Click HERE to watch an exclusive “Behind-The-Scenes” video about Prolacta’s state-of-the-art human milk processing facility.
I hope I”m invited back for another event in the future!
I am once again proud to be a member of The Morgan Leary Vaughan Fund’s Board of Directors because today we sponsored our second education lecture at UConn Health in Farmington, Connecticut entitled “Influence of Gut Bacteria and Human Milk on Neonatal NEC”, as part of their Pediatric Translational Research Seminar Series.
Today’s lecture featured two of our Scientific Advisory Board members: presenter Dr. Michael Caplan and host Dr. Adam Matson. Stephanie Vaughan (President and Co-founder of The Morgan Leary Vaughan Fund) gave a heartfelt introduction into why she started The Morgan Leary Vaughn Fund and how Necrotizing Enterocolitis (NEC) has affected her family since her twins were born prematurely six years ago. You can read Stephanie’s story HERE.
Stephanie’s introduction was followed by Dr. Michael Caplan’s educational (and entertaining!) lecture on how human milk and probiotics may be helping to reduce the amount of premature babies afflicted with NEC.
In premature infants, breast milk feeding is associated with reduced infections and inflammatory diseases such as Necrotizing enterocolitis. NEC is a very serious disease where the intestinal tissue is injured or begins to die off and then a perforation occurs that allows bacteria and waste products to enter a baby’s blood stream. This very often leads to surgery requiring sections of the bowel to be removed and in many cases (about 40%) can lead to death. As more and more babies are surviving births at earlier gestations we must take a larger look into how to prevent this devastating disease and give our future premature babies a better chance at survival.
Dr. Caplan took us through the history of NEC and some of the original studies regarding different theories on what causes NEC and some ways it was treated in the past. He then showed us evidence from various clinical studies on how human milk diets and exclusive human milk diets (including fortifiers made from human milk) are showing some promise reducing the number of cases of NEC in premature babies. Dr. Caplan also showed us some studies on how probiotics are influencing the number of cases of NEC, but he was very careful not to endorse any particular strand or combination of probiotics as they all can have negative side effects because the physiology of each and every baby is very different.
Dr. Caplan endured quite a trip after canceled flights and long Uber rides to get to us and we are very thankful he came. He even showed up with a smile!
Below are a few of Dr. Caplan’s slides for you to view so that you get a feel of what was being discussed.
The Morgan Leary Vaughan Fund was proud to sponsor today’s event at UConn Health and we look forward to future collaborations.
The Morgan Leary Vaughan Fund (Morgan’s Fund) is an all-volunteer, public charity dedicated to Necrotizing Enterocolitis (NEC). Our mission is to promote public awareness about NEC and the potentially devastating effects it can have on preemies and their families, and to advance research to prevent, diagnose, treat, and ultimately cure NEC.
Thank you for your support!