Prolacta Bioscience reassures hospitals of the safety of its human milk-based nutritional products during the coronavirus pandemic

DUARTE, Calif., April 1, 2020 – Prolacta Bioscience^®, the world’s leading hospital provider of 100% human milk-based nutritional products, today notified hospital customers of the safety, quality, and continued supply of its human milk-based nutritional products. Prolacta’s products are used by neonatal intensive care units (NICUs) throughout the world to address the nutritional crisis of prematurity.

“We realize these are uncertain times and there are many questions surrounding the coronavirus. We are providing hospitals with the latest scientific data needed to make informed decisions,” said Scott Elster, president and CEO of Prolacta Bioscience. “We also want to reassure these dedicated clinicians that the pandemic will not affect our commitment to supply their premature infants with life-saving nutritional products.”

Latest Data on Breastmilk and Coronavirus

• The U.S. Centers for Disease Control and Prevention (CDC),¹ the Union of European Neonatal and Perinatal Societies (UENPS),² and the European Center for Disease Prevention and Control (ECDC)³ have all issued statements either that SARS-CoV-2 (coronavirus) does not appear to be present in breastmilk and/or that breastmilk does not appear to be a source of disease transmission.
• Currently, data from China show an absence of detectable coronavirus in breastmilk. Chen et al. studied lactating mothers with coronavirus. Breastmilk of six of those mothers was tested for the presence of SARS-CoV-2.⁴ The virus was not found in any of the milk specimens tested. Kam et al. looked at breastmilk from one mother with coronavirus and this testing also failed to show the presence of the virus.⁵

Prolacta’s Effective Pasteurization Protocol

Prolacta exceeds all state and federal regulations for human milk quality and surpasses the quality and safety standards of all currently operating milk banks.

• All Prolacta products are pasteurized using time and temperature profiles defined by the U.S. Food and Drug Administration (FDA) in its Pasteurized Milk Ordinance (PMO) to ensure destruction of pathogens.
• Prolacta’s pasteurization process has been independently validated using the same robust pathogen inactivation studies used in the biologics industry. This validation demonstrates that Prolacta’s pasteurization provides appropriate bacterial killing and viral inactivation including enveloped viruses. Coronavirus is an enveloped virus.
• Studies of other epidemic coronaviruses, such as the virus responsible for the 2003 SARS epidemic and the virus responsible for the 2012 MERS outbreak, demonstrate that pasteurization is highly effective in inactivating these viruses. These studies were done in diverse carrier media such as plasma products^6,7 and various animal milks⁸ in which the virus was found during epidemic infection.
• Only human milk products manufactured with the FDA-defined pasteurization process, such as Prolacta’s, are clinically proven to be safe and improve health in the NICU.^{9,10,11,12,13} No published clinical data show similar results using human milk products treated by any other method.

Setting the Highest Standard for Human Milk Safety

Prolacta operates the first and only pharmaceutical-grade manufacturing facilities for the testing and processing of human milk. Its two facilities have standard ISO-7 and ISO-8 cleanrooms totaling nearly 21,100 square feet.

• Prolacta modeled its stringent quality and safety protocols on those used in the plasma and blood industries.
• Prolacta has developed, validated, and implemented 19 donor milk screening tests to ensure the safety of its human milk-based nutritional products.
• Prolacta also has implemented the world’s first nucleic acid amplification test (NAAT) capable of directly detecting the presence of infectious disease-causing pathogens and bacteria in donated breastmilk. Since 2018, all donor milk received by Prolacta has been tested using NAAT.

“All Prolacta products, including pasteurized and nutrient-standardized donor milk, are manufactured in the same manner and undergo the same quality and safety protocols,” said Elster. “We are maintaining a full inventory of finished product, as well as raw materials, and have multiple shipping partners to ensure deliveries continue as planned. Our team remains available to handle orders and any issues that arise.”

About Prolacta Bioscience
Prolacta Bioscience^® Inc. is a privately held life sciences company dedicated to Advancing the Science of Human Milk^®. Prolacta is the world’s leading hospital provider of 100% human milk-based nutritional products. These life-saving products have reduced complications and improved the health of more than 63,000 extremely premature infants. The company is also exploring the therapeutic potential of human milk across a wide spectrum of human diseases, including applications for infants requiring surgery for congenital cardiac and gastrointestinal disorders. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta leads the industry with the highest quality and safety standards for the screening and testing of donor milk. Prolacta is a global company with headquarters in Duarte, Calif., and can be found online at prolacta.com, on Twitter @prolacta, on Instagram @prolacta_bioscience, on Facebook at facebook.com/prolacta, and LinkedIn at linkedin.com/company/prolacta-bioscience/.

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Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310.721.9444

References:

1. Coronavirus disease (COVID-19) and breastfeeding. Centers for Disease Control and Prevention. https://www.cdc.gov/breastfeeding/breastfeeding-special-circumstances/maternal-or-infant-illnesses/covid-19-and-breastfeeding.html. Published March 2020. Accessed April 1, 2020.
2. Davanzo R, Mosca F, Moro G, Sandri F, Agosti M, Union of European Neonatal & Perinatal Societies. Breastfeeding and SARS-CoV-2 infection. https://www.uenps.eu/wp-content/uploads/2020/03/14marzo.SIN_UENPS0.pdf. Published February 2020. Accessed March 31, 2020.
3. European Centre for Disease Prevention and Control. Novel coronavirus disease 2019 (COVID-19) pandemic: increased transmission in the EU/EEA and the UK – sixth update. Published March 2020. Accessed March 31, 2020.
4. Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020;395(10226):809-815. doi:10.1016/S0140-6736(20)30360-3
5. Kam KQ, Yung CF, Cui L, et al. A well infant with coronavirus disease 2019 (COVID-19) with high viral load. Clin Infect Dis. 2020. [Epub ahead of print]. doi:10.1093/cid/ciaa201
6. Groner A, Broumis C, Fang R, et al. Effective inactivation of a wide range of viruses by pasteurization. Transfusion. 2018;58(1):41-51. doi:10.1111.trf.14390
7. Yunoki M, Urayama T, Yamamoto I, Abe S, Ikuta K. Heat sensitivity of a SARS-associated coronavirus introduced into plasma products. Vox Sang. 2004;87(4):302-303. doi:10.1111/j.1423-0410.2004.00577.x
8. van Doremalen N, Bushmaker T, Karesh WB, Munster VJ. Stability of Middle East respiratory syndrome coronavirus in milk. Emerg Infect Dis. 2014;20(7):1263-1264. doi:10.3201/eid2007.140500
9. Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016 ;36(3):216-220. doi:10.1038/jp.2015.168
10. Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592-1595. doi:10.1016/j.jpeds.2013.07.011
11. Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012;7(1):29-37. doi:10.1089/bfm.2011.0002
12. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567. doi:10.1016/j.jpeds.2009.10.040
13. Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024