Biothera has multiple co-manufacturers that are cGMP compliant with U.S. Food and Drug Administration regulations. In addition, our facilities are certified Kosher and ISO 9001 or equivalent. All of our facilities are required to have an independent, third-party audit. The patented, proprietary manufacturing process for Wellmune WGP® includes three essential steps:
1. Growth of primary yeast Saccharomyces cerevisiae.
2. Isolation of the cell wall of Saccharomyces cerevisiae.
3. Purification to separate the Wellmune WGP® from other cell wall materials.
To produce soluble Wellmune, additional proprietary steps are performed to separate insoluble portions of the matrix.
Biothera has developed a method for analyzing beta glucan content of raw ingredients as well as finished food, beverage and supplement products that is more accurate and precise than previously described methods. The Glucan Enzymatic Method (GEM™) was published in the Journal of Agricultural and Food Chemistry, a peer-reviewed publication of the American Chemical Society.
Biothera received a “Superior” rating in an independent AIB International audit of the company’s Good Manufacturing Practices (cGMP) at its distribution center in Eagan, Minnesota. The AIB food safety and hygiene standard is one of the strictest standards in the world.
GEM is a solution to shortcomings of traditional glucan assays. Methods employing acid hydrolysis, for example, break down the beta glucan and all other polysaccharides present into glucose. The inability to distinguish between polysaccharides often results in an overestimation of the actual beta glucan content. GEM relies upon selective enzymes that detect beta glucan and break it down to glucose while leaving other polysaccharides intact.
GEM enables food, beverage and supplement manufacturers to confirm scientifically the purity and quality of the ingredients they are adding to their products. Consumers also can have confidence that GEM-tested products contain the beta glucan dosage as labeled.