FAQs – Marketing
The nine human clinical studies with Wellmune can provide support for a wide range of unique structure function claims. Examples of claim areas include immune system support, maintaining overall health and wellness, energy and vitality, stress protection and sports nutrition. Biothera is pleased to support efforts of our customers to develop marketing claims with products containing Wellmune. Our Regulatory Department worked closely with Covington & Burling, a Washington, DC, law firm specializing in food, beverage and supplement law, to develop claims that we believe comply with FDA and FTC regulations. We encourage our customers to consult with their own legal counsel before finalizing their label claims.
Wellmune is currently in more than 100 foods, beverage and supplements in more than 50 countries worldwide. Applications include juices, smoothies, yogurt, toddler formulas, soups, gummies, cookies, bread, fruit chews, functional drinking straws, freezer pops, powdered beverages and single serving shots. Here are some examples of these products. Wellmune also is in numerous developmental projects for a wide range of food, beverage and supplement applications.
Wellmune is a natural ingredient, a beta 1,3/1,6 glucan from a proprietary strain of baker’s yeast. The term “beta glucan” can be confusing because there are many sources of beta glucans (yeast, oats, barley, algae) with widely different health benefits. For example, oat beta glucans are known for cholesterol management properties while yeast beta glucans are identified with immune health. But research shows that even among yeast beta glucans, slight differences in chemical structure can affect biological activity. There are nine clinical studies that support the safety and efficacy of Wellmune. This science cannot be applied to other yeast beta glucans. The U.S. FDA recognized name for this ingredient listing is “baker’s yeast beta glucan.”
The market for immune health products continues to grow rapidly. Biothera is working with numerous food, beverage and supplement companies on product formulations that span a wide range of application categories. There also is plenty of evidence that immunity continues to be a high priority among consumers. A recent survey among 1,579 adults age 18+ found that immune health is one of the top three reasons that people took supplements in the past two years. It was cited more than pain relief, weight control and reducing heart risk.
- Wellmune is a one-of-a-kind technology that is the culmination of more than $300 million in research and development.
- Wellmune is supported by a significant body of research covering safety, mechanism of action, and human clinical studies. Wellmune’s nine clinical studies consistently demonstrate its ability to strengthen the immune system, even during periods of high physical or lifestyle stress. The vast majority of Biothera clinical studies have been published in peer-reviewed science or medical journals.
- All of the research supporting Wellmune was conducted with our own ingredient. Other companies rely on borrowed research that was done with ingredients that were not their own.
FAQs – Serving
The amount of Wellmune uptake is impacted by multiple factors and may vary by individual. Based on published research, Wellmune has efficacious bioactivity at the recommended serving of 250 mg per day. The recommended serving for children is 24 mg per day for children aged 1-2 years and 100 mg or more per day for older children (depending on age and weight). For formulation purposes we recommend 2.5 mg of Wellmune per kg of body weight.
Wellmune should be taken daily to provide maximum immune health benefits. The reason is linked to Wellmune’s unique mechanism of action. Wellmune works by safely boosting neutrophils, the most abundant immune cells in the body, without over stimulating the immune system. The average life span of a neutrophil is approximately 24-36 hours, so it is important to continually take Wellmune to boost new immune cells that the body is constantly producing.
Biothera has conducted multiple studies with Wellmune and has demonstrated bio-equivalent response in pill and liquid forms.
FAQs – Product Formulation/Manufacturing
Biothera manufactures Wellmune at multiple GMP-qualified facilities in the Americas.
There is no chemical and clinical difference between Wellmune soluble and dispersible. They are simply different grades of the same ingredient. Dispersible Wellmune is an easily dispersed but insoluble particulate form of Wellmune and can be formulated into the majority of food, beverage and supplement applications. For those applications requiring a soluble form, water-soluble Wellmune may be more appropriate because of clarity or manufacturing requirements.
In water at 1 mg per milliliter, soluble Wellmune is virtually odorless, clear and has mild to no taste.
Wellmune is packaged in 10 kg boxes. Other packaging can be developed as customer requirements warrant.
Adequate inventories are maintained in Eagan, Minnesota, to supply current demand and forecasted growth. Lead times are typically one week or less.
FAQs – Stability and Quality Standards
Yes. Wellmune has a five-year shelf life from the date of manufacture. Biothera has not encountered food processing conditions that diminish our product’s efficacy.
Wellmune is a stable ingredient and not degraded by temperature, pH or pressures encountered in food or beverage processing. Wellmune is well suited for virtually any manufacturing process.
Quality systems are critical to maintain Biothera’s success. Independent external audits conducted in 2011, 2012 and 2013 rewarded Biothera’s facility with a superior ranking through AIB International.
FAQs – Research
Wellmune is clinically proven to safely boost or prime the immune system to keep the body healthy. While the terms may be used interchangeably, the preferred term we use is boost. Products that stimulate the immune system can create an inflammatory immune response that may be harmful. Wellmune initiates a natural immune response that has evolved over thousands of years. Activated by Wellmune, innate immune cells called neutrophils are now ready, or primed, for activity. Neutrophils primed with Wellmune do not behave differently until a challenge is present. Then with Wellmune, the neutrophils respond more quickly and effectively to signals from the immune system.
Nine human clinical research studies have consistently demonstrated the ability of Wellmune to naturally enhance human immune responses even during periods of high physical and lifestyle stress. Double-blind, placebo-controlled studies involving marathoners, firefighters and other individuals with stressful lifestyles found that Wellmune reduces incidence of upper respiratory tract infection symptoms and improves a sense of overall health.
These findings are not surprising based on the large body of published research demonstrating Wellmune’s unique mechanism of action. Scientists understand how Wellmune works in the body at a molecular and cellular level, making it one of the best understood functional ingredients in the world. Equally important, research also documents that Wellmune does not over stimulate the immune system. Some immune health ingredients stress the immune system in ways that may be harmful over time. Wellmune enhances natural immune function and is safe for daily consumption.
Biothera developed the Glucan Enzymatic Method (GEM®) as a solution to shortcomings of traditional glucan assays. 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. The GEM analytical methods were adopted by the United States Pharmacopeia for the development of the first official monograph for beta glucan from baker’s yeast. The monograph was published 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.
Research on Wellmune has been published in leading peer-reviewed science and medical journals, including Nature, British Journal of Nutrition, Journal of the American College of Nutrition, Journal of Sports Science and Medicine and Journal of Applied Research and Biotherapy. View a complete listing of scientific journals here. In addition, our research has been presented at numerous scientific forums, including Experimental Biology, the American College of Nutrition, the American Society of Sports Medicine and the British Society of Immunology.