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® 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® from other cell wall materials.
To produce soluble Wellmune, additional proprietary steps are performed to separate insoluble portions of the matrix.
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.