Inbiose applies for FDA GRAS approval of four new Human Milk Oligosaccharides
PR90471
GHENT, Belgium, July 6, 2021 /PRNewswire=KYODO JBN/ --
Inbiose, a leading biotech company active in the development of Human Milk
Oligosaccharides (HMOs), is pleased to announce that it has submitted its
application for a Generally Recognized as Safe (GRAS) approval by the US Food &
Drug Administration (FDA) of four HMOs, specifically 6'-Sialyllactose (6'SL),
3-Sialyllactose (3'SL), Lacto-N-Tetraose (LNT) and Lacto-N-neoTetraose (LNnT).
Inbiose will also file for Novel Food approval of these HMOs by the European
Commission (EFSA) in the coming weeks and is preparing a global regulatory
roll-out. Inbiose expects to obtain regulatory approval for these HMOs in 2022
and is currently organizing its industrial production for timely deliveries to
customers in infant nutrition, dietary supplements and functional food and
beverages. Product samples are available for interested parties that wish to
develop innovative products with these HMOs.
"Over the years, Inbiose has earned itself a solid reputation of technological
leadership in the development of HMOs. I am really proud of our team that has
allowed us to take the regulatory step on our way to the market. The approval
of these HMOs in the US and EU will mark the beginning of a whole new range of
advanced HMOs produced by Inbiose" said Prof. Soetaert, CEO and Chairman of
Inbiose.
Inbiose has been developing a wide range of human-identical milk
oligosaccharides that can be industrially produced by sustainable fermentation
processes. Inbiose is currently developing its next generation HMOs that will
permit infant formula to better replicate the composition of breast milk. HMOs
are the newest ingredients for premium infant formula and industry watchers
expect this market to reach Euro 500m by 2025 and grow further to well over
Euro 1bn. The HMO market goes beyond infant nutrition as recent scientific
studies have demonstrated that HMOs may play an important role as bio-active
ingredients for improved immunity, gut health, learning ability and brain
health of the general population.
About Inbiose
Inbiose is a Belgium-based biotech company focused on the research, development
and commercialization of specialty carbohydrates, including human milk
oligosaccharides. Our unique proprietary technology platform "GlycoActives(R)"
enables cost-effective manufacturing of a wide range of specialty carbohydrates
by sustainable fermentation processes.
Photo - https://mma.prnewswire.com/media/1556889/Wim_Soetaert.jpg
Logo - https://mma.prnewswire.com/media/1556149/Inbiose_Logo.jpg
Source: Inbiose
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