DUARTE, Calif., 9 January, 2021 – 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 pasteurisation method is highly effective at inactivating SARS-CoV-2, the virus that causes COVID-19, should it be present in breast milk. 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 birthweight 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 pasteurisation, quality/safety processes and the data showing the ability of pasteurisation to inactivate the virus.’1,2,3,4
As of now, evidence indicates that pasteurisation inactivates SARS-CoV-2 should it be present in breast milk. All of Prolacta’s products are pasteurised using time and temperature profiles defined by the Food and Drug Administration (FDA) in its Pasteurised Milk Ordinance (PMO) to ensure the destruction of pathogens. Prolacta’s pasteurisation 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 pasteurisation provides appropriate bacterial killing and viral inactivation, including inactivating enveloped viruses. SARS-CoV-2 is an enveloped virus.
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 totalling nearly 21,100 square feet.
▪ Prolacta modelled 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, USA, 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/.
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