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Kyowa’s HMO

Quality and Production Certificates

Kyowa’s HMOs are identical to HMOs naturally found in human breast milk.
Each of our HMOs are produced through fermentation technology and are not derived from human milk.
Our HMOs are produced under FSSC22000 and are certified as HALAL and Kosher Diary.


Kyowa’s HMOs (2’-FL, 3’-SL, 6’-SL) are notified as Generally Recognized as Safe (GRAS) to U.S. Food and Drug Administration.


Kyowa Hakko Bio has started filing applications for approval of 2’-FL, 3’-SL and 6’-SL as food ingredient in various countries.
We are also working on the development of other HMOs to expand our pipeline.
Please contact us for more information where our products are available as food ingredients and which HMOs are available as samples for your research and product development.

History of HMO Development in Kyowa Hakko Bio

Mass production of HMOs was difficult due to their complex chemical structure. Therefore, it has not been possible to formulate them in infant formula for a long time. However, by applying our amino acid fermentation technology, we established a HMO production process and achieved mass production. *

[Manufacturing process]

Saccharides (starting material) → Microbial fermentation → Sterilization → Purification → HMOs

1998 World 1st invention for large-scale production of oligosaccharides by fermentation*
1999 Received Nikkei BP Technology Award in Medical Biotechnology section for “World’s First Industrial-Level Production System Technology for Sugar Chains”
2013 Establishment of plant-scale production process of HMOs
Present Production facility for HMOs (HOT-1) has been constructed and 2’-FL, 3’-SL and 6’-SL will be launched successively from 2023, subject to regulatory approval

* T. Endo et al. Large-scale production of CMP-NeuAc and sialylated oligosaccharides through bacterial coupling. Applied Microbiology and Biotechnology, 53, 257-261 (2000)