Prolacta Bioscience Provides Update on Latest SARS-CoV-2 Data and Continued Safety of Its Human Milk-Based Nutritional Products

DUARTE, Calif., Jan. 9, 2021 /PRNewswire/ -- Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products, today provided updated data reinforcing the continued safety, quality, and supply of its human milk-based nutritional products during the COVID-19 pandemic. In the update, Prolacta reiterated how the vat pasteurization method is highly effective at inactivating SARS-CoV-2, the virus that causes COVID-19, should it be present in breastmilk. Used by neonatal intensive care units (NICUs) throughout the world, Prolacta's products as part of an exclusive human milk diet (EHMD) address nutritional risks for low birth weight premature infants.

"We continue to closely review all of the emerging scientific data around the coronavirus and are committed to providing up-to-date guidance regarding the use of our human milk-based nutritional products," said Scott Elster, president and CEO of Prolacta. "We are confident in our pasteurization, quality/safety processes, and the data showing the ability of pasteurization to inactivate the virus."^1-4

Breastmilk and COVID-19 Infection

• While three studies have suggested that transfer of the virus into breastmilk is a possibility,^1,5,6there have been no confirmed cases of an infant contracting SARS-CoV-2 via breastmilk.
• Even if it is possible for SARS-CoV-2 to pass into breastmilk, several studies have now demonstrated that Holder pasteurization inactivates SARS-CoV-2.^1-4
• 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. Two studies were done in diverse carrier media for plasma-derived products,^7,8 and another study was conducted using animal milk⁹ in which the virus was found during epidemic infection.

Prolacta's Effective Pasteurization Protocol
As of now, evidence indicates that pasteurization inactivates SARS-CoV-2 should it be present in breastmilk. All of Prolacta's products are pasteurized using time and temperature profiles defined by the Food and Drug Administration (FDA) in its Pasteurized Milk Ordinance (PMO) to ensure the destruction of pathogens. Prolacta's pasteurization process has been independently validated using the same study design principles as the pathogen inactivation studies used in the biologics industry. This validation demonstrates that Prolacta's pasteurization provides appropriate bacterial killing and viral inactivation, including inactivating enveloped viruses. SARS-CoV-2 is an enveloped virus. 

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 clean rooms 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 more than 20 donor milk screening tests to ensure the quality and safety of its human milk-based nutritional products.

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 as part of an EHMD have reduced complications and improved the health of more than 63,000 extremely premature infants globally.¹⁰ In addition, the company is 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, California, and can be found online at www.prolacta.com, on Twitter @prolacta, on Instagram @prolacta_bioscience, on Facebook at www.facebook.com/prolacta and LinkedIn at www.linkedin.com/company/prolacta-bioscience/.

Media Contact: 
Loren Kosmont
Lkosmont@prolacta.com310-721-9444

References

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SOURCE Prolacta Bioscience