Biothera Analytical Methods Adopted for New Industry Standard
EAGAN, MN — September 8, 2011 — The United States Pharmacopeia (USP), in collaboration with Biothera, has developed the firstofficial monograph for beta glucan from bakers yeast (Saccharomyces Cerevisiae), a natural food, beverage and dietarysupplement ingredient widely recognized for its immune health benefits.
The monograph was recently issued in the Third Supplement of the Seventh Edition of the Food Chemicals Codex, an internationally recognized compendium of standards for the purity and identity of food ingredients.
Biothera is a biotechnology company dedicated to improving immune health. The company manufactures Wellmune WGP®, a proprietary bakers yeast beta glucan clinically proven to prime key immune cells that help keep the body healthy and vital. Biothera contributed the reference standard and two methods for identifying and quantifying the beta 1,3/1,6 branched glucan polymer derived from the cell walls of bakers yeast as well as additional methods to assure the purity of the material.
The Biothera identification method uses Nuclear Magnetic Resonance Spectroscopy to detect glucan branch linkages. To quantify the purity of the beta glucan content, Biothera developed the Glucan Enzymatic Method (GEM™) Assay that was recently published in the ACS Journal of Agricultural and Food Chemistry.
“Biothera is pleased to share its expertise in carbohydrate chemistry to help set the industry standard for characterizing and analyzing beta glucan from bakers yeast,” said Rich Mueller, Biothera chief executive officer.
“We are pleased the USP recognized the technical merit of our analytical methods, and validated and adopted our analytical methods aspart of the new monograph,” said Andy Magee, Ph.D., Biothera vice president of Chemistry.
The USP Expert Committee approved the proposed monographs after being published in Pharmacopeial Forum for public comment. USP sets standards for manufacturers to comply for products legally marketed in the U.S. These monographs address quality, identification, labeling, purity, and potency, among other tests. All beta glucans from bakers yeast must fulfill the requirements of the USP monographs, at a minimum. The monographs will facilitate FDA’s determination of compliance of the marketed products to these public standards.
USP—Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a nonprofit, nongovernmental, standards-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations.
About Biothera, the immune health company
Biothera is a biotechnology company dedicated to improving immune health. The company’s Healthcare Group is a leading provider of natural immune health ingredients for the functional food and beverage, dietary supplement, cosmetic and animal nutrition markets. Biothera’s flagship ingredient is Wellmune WGP, a unique food, beverage and supplement ingredient that is Generally Recognized as Safe (GRAS) under U.S. FDA regulations. It is also patented, Kosher, Halal, non-allergenic and GMO-free. Theingredient is recipient of an IFT Innovation Award and a Frost & Sullivan Excellence in Research Award. More information is available at www.wellmune.com.