Manufacturing and Quality Assurance.
Wellmune® is manufactured by multiple co-manufacturers that are cGMP compliant with U.S. Food and Drug Administration regulations. In addition, our facilities are certified Kosher, Halal and against a GFSI compliant standard. All of our facilities are required to have an independent, third-party audit. The patented, proprietary manufacturing process for Wellmune includes three essential steps:
- The growth of proprietary baker’s yeast (Saccharomyces cerevisiae).
- Isolation of the cell wall of Saccharomyces cerevisiae by autolysis.
- Water-based purification method to separate the Wellmune from other cell wall materials.
To produce soluble Wellmune, additional patented and proprietary steps are performed to separate insoluble portions of the matrix.
Kerry has developed highly effective methods for analyzing yeast beta glucan content of raw ingredients as well as finished food, beverage and supplement products. The Glucan Enzymatic Method (GEM) enables food, beverage and supplement manufacturers to confirm scientifically the purity and quality of the ingredients they are adding to their products. GEM was published in the Journal of Agricultural and Food Chemistry, a peer-reviewed publication of the American Chemical Society. Your consumers can have confidence that GEM-tested products contain the yeast beta glucan amount as labeled.