Large-scale production of sialylated human milk sugars

Scaling-up flow processes for the chemoenzymatic synthesis of a sialylated glycan

NIH-funded research Zymtronix Catalytic Systems, INC. · NIH-11176054

This project develops methods to make specific human milk sugars more efficiently so they can be used in infant formulas or as therapies for gut inflammation, allergies, and autoimmune conditions in infants and adults.

Quick facts

Grant typeSbir 2 grant
Study typeNIH-funded research
Funding institutionZymtronix Catalytic Systems, INC. NIH-funded
Lab location1 site (Durham, UNITED STATES)
Project IDNIH-11176054 on NIH RePORTER

What this research studies

From a patient perspective, the team is working to produce human milk oligosaccharides (HMOs)—including sialylated sugars—at much larger scale using a cell-free, enzyme-based manufacturing approach. They use immobilized enzymes and continuous flow processes to increase yield and purity compared with small-batch methods. Phase I showed they could make several HMOs, and this Phase II work focuses on scaling and process improvements so the sugars are available in quantities needed for testing and use. The work is being done by Zymtronix in Durham using their multienzyme immobilization technology.

Who could benefit from this research

Good fit: Future studies enabled by this work would be most relevant to infants (via formula) and to people of any age with gut inflammatory disorders, allergic diseases, or autoimmune conditions who might try HMO-based interventions.

Not a fit: People without gut, allergic, or autoimmune conditions or those seeking an immediate clinical treatment are unlikely to benefit directly from this manufacturing-focused project.

Why it matters

Potential benefit: If successful, this could make pure human milk sugars widely available for safer infant formulas and new therapies for gut inflammation, allergies, and autoimmune diseases.

How similar studies have performed: Earlier small-scale and Phase I production work successfully made multiple HMOs, but clinical benefit in humans remains to be established.

Where this research is happening

Durham, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Allergic DiseaseAutoimmune Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.