Knowledge Center

Company

1. What does Prolacta do?
   Prolacta is a research driven company dedicated to advancing the science of human milk. We produce specialty nutritional formulations made exclusively from human milk for critically ill premature infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit.. All our products are clinically proven to meet the needs of these infants. Prolacta is the first and only company to produce an HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. made from 100% human milk, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk.™. It is added to mothers' own milk or to donor milk. 

2. Are there other companies or organizations that offer HMFs made from human milk?
   Prolacta is the first and only company to provide a fortifier made from 100% human milk; Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk.. Our products are specialty formulations of human milk that meet the nutritional needs of critically ill, premature infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit., as prescribed by neonatologists. 

3. Is Prolacta a for-profit company?
   Yes. We have invested over 30 million dollars in research, clinical studies and facilities to develop and test our human milk derived products. This world class research and development would not have been possible in a non-profit business model. 

4. Is Prolacta a milk bank?
   Prolacta has set up a network of affiliated milk collection organizations. These organizations can be found in hospitals, birthing centers, or associated with charities. Depending on the organization, they share the responsibilities of qualifying the donors and collecting the milk with Prolacta. All affiliated milk collection organizations have all milk sent to Prolacta for processing. 

5. Does Prolacta participate in milk sharing?
   No. We are not involved with nor do we promote milk sharing. Human milk that is exchanged through informal processes may not always be screened, tested nor pasteurized. Additionally, the donors may not always be pre-screened or tested for viruses and drugs of abuse, which can be very dangerous to the recipient. 

6. What does Prolacta do with the milk they collect through the affiliated milk banks?
   The milk that is collected through affiliated milk banks is tested, pasteurized and formulated into nutritional products exclusively for in hospital use. The formulations are made specifically to treat critically ill and premature babies that are in the NICUNICU
   Neonatal/Newborn Intensive Care Unit.. The donations do not serve as substitutes for mother's milk if a baby in not under hospital care. 

7. Are you competing against non-profit milk banks?
   No. Prolacta's lead product, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., is specially designed to be used with mother's own milk, which is the best possible nutrition for critically ill premature infants. We are the only organization to provide HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. made from 100% human milk. It is our objective to provide the best possible nutritional formulations made from 100% human milk for the premature baby while receiving care in the NICUNICU
   Neonatal/Newborn Intensive Care Unit.. 

Products

1. What are your products?
   Prolacta's commitment to advancing the science of human milk™ has led us to develop and offer the only liquid HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. derived from 100% human milk, as opposed to other HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients.s, which are derived from cow's milk. Our line of liquid human milk-based fortifiers, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., provide Very Low Birth Weight (VLBWVLBW
   Very low birth weight; a baby weighing 1,500g or less.) premature infants with the nutrition necessary to support appropriate growth and development. Prolacta's human milk-based products have been formulated to deliver exact caloric and protein levels every time. These products are critical to premature infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit. who require higher levels of protein and calories than can be provided by mothers' milk alone. Prolacta's commitment to advancing the science of human milk™ has led us to develop and offer the only liquid HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. derived from 100% human milk, as opposed to other HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients.s, which are derived from cow's milk. Our line of liquid human milk-based fortifiers, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., provide Very Low Birth Weight (VLBWVLBW
   Very low birth weight; a baby weighing 1,500g or less.) premature infants with the nutrition necessary to support appropriate growth and development. Prolacta's human milk-based products have been formulated to deliver exact caloric and protein levels every time. These products are critical to premature infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit. who require higher levels of protein and calories than can be provided by mothers' milk alone. 

2. Where are your products being used?
   Prolacta's completely human milk formulations are used in NICUsNICU
   Neonatal/Newborn Intensive Care Unit. across the nation, for the most fragile babies. 

3. How do you get human milk for your products?
   Prolacta receives donated breast milk from dedicated, healthy, nursing women who have undergone extensive medical and social screening similar to the blood donor screening process. 

4. How do I know my preemie will benefit from Prolacta's fortifier products?
   A recent study published in the Journal of Pediatrics showed that when added to human milk, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. clinically reduced the odds of developing NECNEC
   Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants. by 77% in premature infants weighing 500 g – 1250 g at birth, when compared to infants receiving a cow's milk-based HMF (also commonly called breast milk fortifier) or, when mother's milk was unavailable, preterm infant formula. Earlier studies have also demonstrated that for infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit., human milk decreases the incidence of diseases such as necrotizing enterocolitis (NECNEC
   Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants.), bronchopulmonary dysplasia (BPD), and sepsis (infection). 

5. Are there any side effects?
   Currently, there are no known side effects based on the six clinical trials and significant commercial use of the products. Prolacta continues to monitor the products in the same way that other therapeutic products are monitored. 

6. Why is it vital that critically ill premature infants get additional calories, fat, protein and minerals?
   Critically ill premature infants have special dietary needs requiring higher levels of protein and calories than a full-term baby would need. These needs are usually met by blood delivered through the mother's placenta during the last trimester of pregnancy. Unfortunately, premature infants miss out on this important period of development, so the increased nutrition is provided by supplementing mother's own milk with HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients..  

7. What is the current standard of care for fortification of human milk in the NICU?
   Clinical trials were conducted which showed major improvements with the use of human milk fortifier (also commonly called breast milk fortifier) in growth and developmental outcomes for premature infants. Fortification is now considered standard of care for these infants and not to fortify their milk would be considered unethical under almost all circumstances. 

8. What is the average size baby that uses Prolacta products?
   The average baby that was evaluated in our clinical studies was approximately 950 grams (2.14 pounds) at birth. Prolacta recommends the use of its products in babies weighing 1250 grams (2.lbs. 12 oz) or less at birth. 

9. Should a mother try to produce breast milk while her baby is receiving Prolact+ H²MF in the NICU?
   Absolutely. A mother's milk is the gold standard of nutrition. Prolacta's human milk fortifier (also commonly called breast milk fortifier) was specially designed to be used with mothers' own milk. This combination will provide infants with the best possible nutrition. 

10. Does Prolacta have proof that human milk is better than formula?
    There are numerous studies that demonstrate the superiority of human milk over cow's milk as the best nutrition for babies. These and other data have led the American Academy of Pediatrics to state that breastfeeding is important for optimal infant and child health. Additionally, a recently completed randomized, controlled clinical trial demonstrated that a completely human milk-based diet, including Prolact+ H²MFProlact+ H²MF
    Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., reduced the incidence and severity of NECNEC
    Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants. in premature infants weighing 500 g - 1250g at birth when compared to infants receiving human milk fortified with cow's milk-based HMFHMF
    Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. or, when mother's milk was unavailable, preterm infant formula. 

11. What were the changes Prolacta made to their bottles this year and why?
    The changes to the Prolact+ H²MFProlact+ H²MF
    Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. and Neo20 bottles were: a new, very sturdy cap and bottle system which is more durable than the previous bottles; the shape is now cylindrical, which makes the bottle more conducive when withdrawing mixed feeding solutions; the size of the bottle is reduced (from 150mL to 125mL) so less storage space is needed; and they are now manufactured by Nalgene®. 

12. Were there any other changes made to the formulations or preparation instructions associated with the new bottle?
    No changes have been made to the formulations of either the Prolact+ H²MFProlact+ H²MF
    Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. or Neo20 line of products. Preparation, handling and thawing of the products remain the same as well. However, we have made a change to the bottle itself; there are no longer graduations on the outside of the bottle. These markings were meant only to be a guide. 

13. If the graduation lines are not on the bottle anymore, how do I measure the final product volume?
    To ensure accuracy, each bottle of Prolact+ H²MFProlact+ H²MF
    Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. is filled using a filling unit that can dispense a volume within the 0.25mL. The filling unit has gone through a rigorous testing protocol to ensure that the unit does fill within 0.25mL. In manufacturing, we ensure that the minimum listed on the label is dispensed in the bottle by setting the target fill higher to account for the tolerance in the filling machine. 

14. Can you give me an example of how you ensure the proper amount is provided in each bottle?
    For example, when we are filling Prolact+4 20mL, the target fill for each bottle is 20.3mL. With this target, the amount dispensed by the filling unit is between 20.05mL and 20.6mL. This ensures that there will always be a minimum of 20mL of product dispensed in each bottle. 

15. What is the proper way to prepare Prolacta's products for use?
    Always refer to the corresponding product insert of the formulation you are administering for proper use and administration of all Prolacta products. If you would like to request more copies, please contact us at (626) 599-6260, info@prolacta.com or go to the Products page to download a PDF. 

Product Costs

1. Does Prolacta sell milk to non-health care professionals?
   No. All human milk-based formulations made by Prolacta are administered exclusively under a physican's supervision while the infant is in the hospital. 

2. If a mother cannot provide breast milk for her baby, can she purchase some from Prolacta for at home use?
   No. Prolacta's formulations are only sold to hospitals specifically for premature and critically ill babies. 

3. Since parents cannot get human milk directly from Prolacta for their babies, where can they go to get it?
   There are several groups that provide human milk for babies. We recommend talking to your pediatrician to find the best source of human milk for your baby. 

4. If a baby is prescribed Prolacta's human milk products, how much does it cost a parent?
   Prolacta never charges a parent for product. The cost of Prolacta products is, in most cases, under two percent of the total cost of care for a VLBWVLBW
   Very low birth weight; a baby weighing 1,500g or less. infant. Prolacta's products are treated in the same manner as most products used to provide patient care in hospital. In many cases medical insurance covers the cost of the products. In other cases hospitals are willing to absorb the cost. In fact, hospitals and the health care system save money using Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. because of the cost savings realized due to the reduced incidence and severity of NECNEC
   Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants. seen in our clinical trial. 

5. Why doesn't Prolacta pay mothers for their milk donations, but sells the end product?
   The current practice in North America is to accept breast milk donations without compensating the mother for the milk donation. However, we do supply breast milk storage bags, cover all shipping expenses, and bear the cost for complete donor testing. Some of Prolacta’s affiliated milk banks offer charitable contributions on the donors’ behalf based on the amount of milk donated. Prolacta affiliated milk banks receive payment from Prolacta Bioscience for the milk they collect.
   
   Prolacta has invested over $30 million in research and clinical development of our human milk products, which substantiates the benefit of an exclusively human milk diet in these tiny infants and in our pharmaceutical grade processing facility. The primary product produced by Prolacta is a human milk fortifier that is used exclusively in the NICUNICU
   Neonatal/Newborn Intensive Care Unit. to assist premature babies with growth and to reduce the incidence of developing Necrotizing Enterocolitis (NEC). The two clinical studies that were conducted using this product showed the benefit of a 100% human milk diet in EPEP
   Extremely Premature: Infants weighing between 500 and 1250 grams at birth. infants, thus allowing for hospitals to either absorb the cost of the product or obtain healthcare reimbursement. A parent is never charged for our products. If we did not generate any revenue from the sale of our products, we wouldn’t have been able to conduct such clinical trials, nor any other continuing research—both existing and forthcoming— on how our human milk products are helping save premature infants. In addition, Prolacta has built a state-of-the-art facility for the proper screening, DNA testing and processing of donor milk, similar to what is done in the plasma industry. Knowing how closely related blood and breast milk are (in terms of disease transmission), our manufacturing process has been designed for the highest degree of product quality to ensure the safety of all our milk products that go to treat and benefit these tiny, vulnerable babies. 

Parents

1. Why does my baby need a human milk fortifier?
   Premature babies, especially babies that weigh 2 pounds 12 ounces or less at birth, have very special nutritional needs. For example, premature babies need more energy to grow than term babies. Premature babies also grow at a rapid pace, so they need more protein than term babies. Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier (also commonly called breast milk fortifier) made from 100% human milk. is the only human milk fortifier (also commonly called breast milk fortifier) made from breast milk, and it helps provide the additional nutrients your baby needs.*
   
   *Kleinman R, ed. Pediatric Nutrition Handbook. 6th ed. 2009: 31-39 

2. Why isn't my breast milk sufficient nutrition for my baby?
   The American Academy of Pediatrics has recognized that breast milk alone does not meet the increased nutritional needs of premature infants*. Critically ill, premature infants have special dietary needs requiring higher levels of protein and calories than a full-term baby would need. These needs are usually met by blood delivered through the mother's placenta during the last trimester of pregnancy. Unfortunately, premature infants miss out on this important period of development, so the increased nutrition is provided by supplementing mother's own milk with HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients..
   
   *Kleinman R, ed. Pediatric Nutrition Handbook. 6th ed. 2009: 31-39 

3. Are there other fortifiers available other than Prolact+ H²MF?
   Yes, there are other fortifiers for preterm infants, but Prolact+ H²MF is the only 100% human milk fortifier. Other fortifiers are made from cow's milk. It has been shown that babies weighing between 500 g to 1250 g at birth, given a complete human milk diet including Prolact+ H²MF, showed a 77% reduction in the odds of developing NEC when compared with to infants receiving human milk fortified with cow's milk-based milk fortifier. 

4. Where does Prolact+ H²MF come from?
   The breast milk used to make Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. is donated voluntarily by mothers who want to give their extra breast milk to help others. It is pasteurized, concentrated, fortified with minerals, and manufactured under strict quality-control processes to ensure consistent quality and nutrient content. 

5. Can I still give my baby my breast milk?
   Yes, your breast milk is still very important, but for premature babies like yours, it will not provide enough protein, calories, vitamins, and minerals to meet your baby's nutritional needs.* That's why your doctor may decide to fortify your breast milk with a fortifier made from human milk called Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk..
   
   *Kleinman R, ed. Pediatric Nutrition Handbook. 6th ed. 2009: 31-39 

6. Can my breast milk be made into fortifier for my baby?
   The amount of time required to collect, process and test your milk to the highest safety standards as Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., would surpass the time your baby is on fortifier. But if you decide in the future that you have extra breast milk, we would encourage you to donate to a milk bank in order to help other infants in need. For more information on donating, you can visit www.milkbanking.net or www.helpinghandsbank.com. 

Safety & Processing

1. How do I know that Prolacta's products are safe?
   Our dedication to advancing the science of human milk™ has led us to build a one-of-a-kind, state of the art manufacturing facility. Our products have been safely used in NICUNICU
   Neonatal/Newborn Intensive Care Unit.s throughout the United States and Europe. We use the most sophisticated and innovative processes, pasteurization, and filling methods to ensure the highest possible level of product safety and quality. This includes final testing for microbiological and viral contamination. Viruses are detected using polymerase chain reaction, which is a method that can detect as little as one copy of the virus in a sample by amplifying a short sequence of the viral DNADNA
   Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. (or RNARNA
   Ribonucleic acid, in some viruses, performs the role of DNA.) to create many copies.
   
   Please refer to our product processing flow diagram for a summary of the processing (View Diagram) 

2. Is Prolacta regulated by any federal or state agencies?
   Yes. Prolacta products are regulated by the FDA. Prolacta's facility is licensed as a tissue bank by the states of California, New York, and Maryland which all require such a license for human milk banking. 

3. How do you know your process kills bacteria and inactivates viruses?
   Testing performed at independent laboratories has shown that our process inactivates HIVHIV
   Human immunodeficiency virus is the virus that causes acquired immune deficiency syndrome (AIDS). , HBVHBV
   The hepatitis B virus is a cause of hepatitis, a liver disease. It ranges in severity from a mild illness, lasting a few weeks (acute), to a serious long-term (chronic) illness that can lead to liver failure or liver cancer., CMVCMV
   Cytomegalovirus is a group of human herpes viruses that can cause birth defects and can affect humans with impaired immunological systems. and HCVHCV
   The hepatitis C virus is a cause of hepatitis, a liver disease. HCV infection sometimes results in an acute illness, but most often becomes a chronic condition that can lead to cirrhosis of the liver and liver cancer. and is effective against intra and extra cellular virus. It also kills bacteria such as Staphylococcus aureus and E. coli. 

4. How are Prolacta products able to meet the unique nutritional needs of the VLBW premature infants?
   By concentrating human milk proteins and providing them in different volumes, Prolacta formulations give neonatologists the widest range of options to meet the latest nutritional recommendations for critically ill premature infants from leading neonatal experts. 

5. Infant deaths in NICUs have been associated with Enterobacter sakasakii contamination. Do Prolacta's products contain this risk?
   Prolacta Bioscience was saddened to learn of the infant deaths in NICUNICU
   Neonatal/Newborn Intensive Care Unit.s that were reportedly associated with Cronobacter (Enterobacter) sakazakii from powdered fortifier. Contamination by E. sakazakii appears to be limited to the manufacturing processes used to make powdered formula products. We want to assure our customers and the parents of the most delicate babies that Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. is a liquid ? not powder – and meets ADA and CDC guidelines for the use of liquid feedings in the NICUNICU
   Neonatal/Newborn Intensive Care Unit.. 

Donors

1. How are breast milk donors screened prior to donating milk?
   Breast milk donations follow a rigorous screening process based on the blood banking model. Prolacta is the only organization that uses these combined safety steps:

   1. Potential breast milk donors are screened through a medical history survey. After the screening, the donor is entered into Prolacta's secure database and assigned a donor number.
   2. Once the potential donor passes the medical history survey, she must obtain written approval from her physician and her baby's pediatrician before she can continue in the donation process.
   3. The potential donor measures the temperature in her freezer with a thermometer provided by Prolacta. The temperature must be cold enough to store human milk or, unfortunately, the potential donor may not donate.
   4. A blood test and a DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. cheek swab are conducted. The blood test screens for several infectious agents including HIVHIV
      Human immunodeficiency virus is the virus that causes acquired immune deficiency syndrome (AIDS). 1&2, HTLVHTLV
      Human T- lymphotropic virus is a retrovirus that causes some forms of lymphoma, and is in the same class of virus as the AIDS virus, HIV-1. I&II, HBVHBV
      The hepatitis B virus is a cause of hepatitis, a liver disease. It ranges in severity from a mild illness, lasting a few weeks (acute), to a serious long-term (chronic) illness that can lead to liver failure or liver cancer., HCVHCV
      The hepatitis C virus is a cause of hepatitis, a liver disease. HCV infection sometimes results in an acute illness, but most often becomes a chronic condition that can lead to cirrhosis of the liver and liver cancer., and syphilis. The DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. cheek swab is used to create a donor DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. ID. This DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. ID will be used later to ensure the milk received is from the donor that was blood tested.
   5. If the potential donor passes the screening and meets all of the requirements outlined above, she is qualified to be a breast milk donor for a four month period. After four months, if she wishes to continue donating, she must complete a new medical history survey and have another blood test.

    

2. Does Prolacta pay breast milk donors?
   Our aim is to collect and process only a mother's surplus milk – milk that may otherwise be poured down the drain. To that end, we would not want to provide any financial incentive for a mother to donate milk which would, and should, be fed to her own infant.
   
   In addition to the donated breast milk being used to make nutritional products for infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit., Prolacta partners with charitable organizations and provides direct financial contributions for the milk that is collected. Prolacta gives monetary donations to these organizations to honor the gifts of love from these generous mothers. 

3. What are some of the organizations Prolacta is currently working with?
   Prolacta is currently partnered with Susan G. Komen for the Cure? to support the fight against breast cancer. The synergy between Prolacta and Komen for the Cure is natural, as there is a correlation between breast-feeding and a reduced risk of breast cancer in women.
   
   Prolacta's financial commitment is to donate one dollar per ounce of qualified breast milk collected through the Helping Hands Milk Bank (www.helpinghandsbank.com). Their minimum annual commitment will be $25,000, which will help Komen fund life-saving research and community outreach projects. Komen is the world's largest grassroots network of breast cancer survivors and activists fighting to save lives, empower people, ensure quality care for all and energize science to find the cures.
   
   Prolacta has also partnered with the International Breast Milk Project. They signed a five-year agreement (which began November 20, 2010) that states Prolacta will process all of donated breast milk collected through IBMP. Annually, Prolacta will process 25 percent of the first 400,000 ounces of donated breast milk for infants in Africa who have been orphaned due to HIVHIV
   Human immunodeficiency virus is the virus that causes acquired immune deficiency syndrome (AIDS). /AIDS, or who are suffering from HIVHIV
   Human immunodeficiency virus is the virus that causes acquired immune deficiency syndrome (AIDS). /AIDS, malnourishment, poverty and disease. The remaining 75 percent will stay in the United States to make Prolacta's human-milk-derived HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. for critically ill and premature infants in neonatal intensive care units (NICUNICU
   Neonatal/Newborn Intensive Care Unit.). Should IBMP's breast milk donations exceed 400,000 ounces, 10 percent of that amount above 400,000 ounces will be processed for shipment to Africa, and the remaining milk will stay in the U.S. Additionally, Prolacta will donate one dollar to IBMP for every ounce of milk that remains in the U.S. 

Abbott Co-Promotion Agreement

1. What is the co-promotion arrangement between Abbott Nutrition and Prolacta Bioscience^®?
   This co-promotion agreement increases the ability of health care professionals across the U.S. to access Prolacta products, thus giving them more options in the NICU to help support growth and development of the smallest premature infants (≤1250g/2lbs 12 oz). Abbott Nutrition will use its national reach and expertise to broaden the availability of Prolacta Bioscience 100% human milk formulations to health care providers who care for these fragile patients. 

2. What is the value of the Abbott Nutrition and Prolacta Bioscience co-promotion agreement to health care professionals?
   This co-promotion agreement increases the ability of health care professionals across the U.S. to access Prolacta products, thus giving them more options in the NICUNICU
   Neonatal/Newborn Intensive Care Unit. to help support growth and development of the smallest premature infants (?1250g/2lbs 12 oz). Abbott Nutrition will use its national reach and expertise to broaden the availability of Prolacta Bioscience 100% human liquid milk formulations to health care providers who care for these fragile patients.
   
   Prolacta Bioscience is known for its expertise in innovative manufacturing and processing of human milk. When added to human milk, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. was clinically demonstrated to reduce the odds of developing NECNEC
   Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants. by 77% in premature infants weighing between 500g and 1250 g at birth, when compare to infants receiving human milk fortified with cow's milk-based HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. or, when supply of mother's own milk was insufficient, preterm infant formula.*
   
    

3. What are Prolacta's products that Abbott Nutrition will be co-promoting in the NICU?
   Prolact+ H²MF^® line of liquid human milk fortifiers:

   • Prolact+4 is formulated to fortify breast milk to a minimum of 24 Cal/fl oz. (82 Cal/100 mL). It fortifies breast milk to a target of 2.3 g of protein in 100 mL. It is available in 10mL and 20mL volumes
   • Prolact+6 is formulated to fortify breast milk to a minimum of 26 Cal/fl oz. (89 Cal/100 mL). It fortifies breast milk to a target of 2.8 g of protein in 100 mL. It is available in a 30 mL volume
   • Prolact+8 is formulated to fortify breast milk to a minimum of 28 Cal/fl oz. (97 Cal/100 mL). It fortifies breast milk to a target of 3.2 g of protein in 100 mL. It is available in a 40 mL volume
   • Prolact+10 is formulated to fortify breast milk to a minimum of 30 Cal/fl oz. (104 Cal/100 mL). It fortifies breast milk to a target of 3.7 g of protein in 100 mL. It is available in a 50 mL volume

    

4. For more information about Prolacta's Products or to order:
   Orders for Prolacta's products will continue to be processed by Prolacta. In addition Abbott Nutrition representatives will also be able to assist health care professionals in the ordering process. Customers should continue to contact their current Prolacta representative. They may also place an order by contacting Prolacta Customer Service at (888) 776-5228 (888- PROLACT) or email info@prolacta.com.
   Prolacta's products are available for health care professional use only. 

Milk Banking

1. Why should I donate?
   If you have extra milk, it can be processed into specialty formulations for the nutritional needs of premature and critically ill infants in neonatal intensive care units. Many moms donate their extra milk to help babies in need because they have had a preterm baby in the past or know someone who has had that experience. Breast milk donors report a sense of satisfaction knowing they are providing their milk to help premature or sick infants.  

2. How do I know if I am a candidate to donate milk?
   Almost any nursing mother can become a breast milk donor. If you are healthy with a good medical history, you are a likely candidate. You will need to complete a medical survey, get medical confirmation from your doctor and your baby's pediatrician, have your blood tested for diseases and give a cheek cell sample, all at no cost to you. You will be informed of any test results that would indicate a health problem so that you can follow up with your doctor. If all of your results are fine, you can begin donating. 

3. Will I have enough milk for my baby if I donate?
   The milk bank only wants excess milk. Make sure that your own baby's needs are met before donating milk. That being said, your body makes milk on a supply and demand basis and adjusts to the amount of milk needed. If you are worried about your baby getting enough milk, you can express an hour or so after feeding your baby. If your baby's doctor is happy with your baby's weight gain, there is no need to worry about having enough milk. 

4. Can I donate milk I pumped prior to being qualified as a donor (previously collected milk)?
   You can donate previously collected milk as long as it is less than 10 months old and you become a qualified breast milk donor. Also, the following conditions must be met to accept previously collected milk.
   
   

   1. If you become a qualified donor, all previously collected milk may be accepted if it was pumped under the same conditions (i.e. milk bank approved medical conditions) as when you became qualified.
   2. All previously collected milk must have been frozen immediately after pumping and stored in bags or bottles designed to store human milk (e.g. Lansinoh breast milk storage bags). We cannot accept milk that was stored in reused food containers. For example, we cannot take milk that was stored in old dairy milk cartons or juice bottles.
   3. All previously collected milk must have been continuously frozen since the time it was first pumped. The milk could never have been thawed and refrozen.
   4. We can only accept milk with one pumping per container. Please do not store one container in the refrigerator and add to the container over multiple pumpings. The main reasons are to avoid excess bacterial growth that can occur along with increased chance of rancidity of the milk.
   5. All previously collected milk should be fully dated with the month, day and year the milk was expressed. It is also very helpful if you can write the last five digits of your assigned donor number (you will be assigned a number as soon as you start the qualification process) on the container.
   6. All previously collected milk must be received not later than 10 months from the date of expression.

    

5. When can I start expressing milk for the milk bank?
   You should establish breastfeeding for your own baby before you begin donating. We recommend you wait three to four weeks after your baby's birth to begin the application process to become a donor and then only do so if your baby is doing well and gaining weight. 

6. When should I express?
   When and how often you express your milk is up to you. Most donors find it easier to set a time each day to express milk. Most mothers have more milk in the morning, so mornings are a good time to pump. It can be harder to collect milk if you do not express it regularly. Some moms express from one breast while their babies feed from the other. 

7. What equipment will I need as a breast milk donor?
   The milk bank will provide each donor with breast milk storage bags for storing their expressed milk once the donor becomes qualified. Donors will need to obtain a breast pump to express their milk for donation. 

8. How do I prepare to express my milk?
   Because you are pumping for critically ill babies, it is very important to carefully wash your hands with hot, soapy water. The water temperature should be as hot as can be tolerated without burning the skin. If you shower daily, you do not need to wash your breasts before pumping. If you are not able to shower daily, wash your breasts once a day. Take extra time to thoroughly wash your hands because harmful bacteria can be transmitted from your hands to the pumped milk. Though not necessarily dangerous to full term babies, some of these bacteria are dangerous to critically ill infants in the NICU and are not killed through pasteurization. Your donation will be tested for these bacteria and if they are found, your milk will be discarded. Do not handle your pump or your collection containers until you have washed your hands. Wash your pump parts regularly and collect breast milk into a dry, clean container which has been scrubbed with hot soapy water and thoroughly rinsed. The use of a sponge for washing is not recommended unless the sponge is only used to wash your breast milk bottles and the sponge is allowed to dry between uses. If possible, after the bottles and pump parts have been washed, run them through the dishwasher to sanitize them. Breast massage sometimes helps the flow of milk. After massaging the breast, roll the nipple back and forth using your index finger and thumb. Stretch the nipple slightly. This will encourage the release of hormones that help the flow of milk. 

9. How should I store the milk prior to shipping?
   Pump directly into the cleaned bottle connected to the pump. When you have finished your pumping session or the bottle is full, transfer the milk into a breast milk storage bag. Freeze the milk immediately after expressing. Containers should be stored separately from other foods in the freezer. Do not place multiple pumpings in a single breast milk storage bag. 

10. What if I have taken medications?
    Check with your milk bank about any medications you are taking, including over-the-counter remedies (those you can buy without a prescription from your doctor). The milk bank will tell you whether you qualify to donate while taking your medications. 

11. What if I am ill?
    Please contact the milk bank whenever you are feeling ill or if anyone in the family is ill. They will tell you that you should stop donating until your illness passes and inform you when it is okay to resume pumping for donation. 

12. Can I drink alcohol while donating?
    Your milk bank will accept milk from donors consuming up to two units of alcohol per day (a unit is equal to one glass of wine, one beer or one shot of liquor). 

13. What do I do if I go out of town?
    This is up to you. Expressing when you are away from home can help you maintain your milk supply, especially if you are away from your baby. However, any milk that is expressed while you are traveling cannot be donated. 

14. How do I get the milk to the Milk Bank?
    We will provide you with a cold shipping container to ship the milk directly to Prolacta Bioscience. We usually ask that you donate your milk when you have a minimum of 25 breast milk storage bags; however, if you have been pumping and storing milk prior to becoming a donor, we will accept milk that has been properly stored for up to 10 months. 

15. Does the milk bank have a confidentiality policy?
    Any health information collected about donors remains confidential. 

16. Will only babies receive my donated milk?
    Nearly all the breast milk donated will go to sick babies in hospitals after processing at Prolacta Bioscience. Following screening, testing, formulation and processing, the specialized milk formulations are sold to hospitals for use in the Neonatal Intensive Care Unit. A small portion of your donated milk may be used for ongoing human breast milk research. 

17. Will I be paid for my donations?
    The current practice in North America is to accept breast milk donations without compensating the mother for the milk donation. However, we do supply breast milk storage bags, cover all shipping expenses, and bear the cost for complete donor testing. Some of Prolacta’s affiliated milk banks offer charitable contributions on the donors’ behalf based on the amount of milk donated. Prolacta affiliated milk banks receive payment from Prolacta Bioscience for the milk they collect. 

18. What is qualified milk?
    Qualified milk is donated milk which has met all the qualification guidelines. This includes two main phases: qualification of the donor and qualification of the milk she donates. Qualification of the donor includes medical history screening, freezer qualification, DNA profile creation, and viral blood screening. After the donor qualification is completed, she may send her milk to the milk bank. Once the milk is received at Prolacta Bioscience it must undergo and pass several rigorous testing procedures, including but not limited to, bacterial screening, drug screening, and DNA matching. Upon successful completion of these screening procedures, the milk is considered qualified for use in making 100% human milk fortifiers and standardized human milk for use in the NICU. 

19. What if I only want to make a one time donation? I've been pumping extra milk for months and I have more than my baby will ever take.
    One time donations of 100 ounces or more are welcome. Please tell us how much you have in storage and how long it has been stored. 

20. Does Prolacta give the milk to hospitals or sell it? Is Prolacta a nonprofit company?
    Prolacta Bioscience produces human milk fortifier (also commonly called breast milk fortifier). Prolact+ H²MF is the first and only human milk fortifier made from 100% human breast milk (as opposed to cow's milk). H²MF is intended for critically ill and premature infants in the NICU. Although your donated milk forms the precious raw material needed by these infants, extensive testing, formulation and processing must be done so that doctors can feel confident that the human milk formulations they give their patients are as safe as possible. In order to provide this processing and formulation, millions of dollars were invested in processing equipment and testing. Much like the blood banking industry, the blood is donated by individuals, tested, processed and sold by blood processors. Prolacta Bioscience is a for profit company that has built a business model that is sustainable so that parents of preterm babies can trust that there will be a ready source of safe human milk formulations when babies need it. 

21. What resources are available if I have more questions?
    Contact us for more information. 

22. After lactation begins, how long can a nursing mother donate?
    There is no time limit on how long you can donate your milk. Since Prolacta Bioscience blends and formulates the milk specifically for preterm babies, there is less concern about minor variations in nutrients that may occur later in lactation.