“We have had it for some time,” Michael Shahani, director of operations at Nebraska Cultures told NutraIngredients-USA. What’s new is the company is compiling new stability data, which Shahani said should be ready by early November.
The new ingredient shares with other bacillus coagulans strains the ability to form spores, hard shells around the mircroorganisms that protect them from harsh conditions until they enter an environment ripe for germination, such as the human GI tract. This species of microorganism has been known for almost 100 years, having first been isolated and described in 1915.
This makes them far hardier than their non-spore forming brethren. Spore formers don’t need refrigeration, and they can survive a much wider temperature range than other species and still retain their viability.
Spore forming probiotics proliferate
Nebraska Cultures, based in Walnut Creek, Calif., isn’t the only player making news in the space. Ganeden Biotech, long the sector leader, recently announced it had achieved FDA no-objection GRAS status for its bacillus coagulans strain, labeled BC30. Ganeden, based in Mayfield Heights, Ohio, which sold the supplements side of its business to Schiff Nutrition in 2011, has had success in placing its ingredient in a wide variety of food and beverage applications. Clearing the highest GRAS hurdle will open up fresh fields for the ingredient, as many major CPG companies want to see a no-objection letter before they begin considering whether to use a particular ingredient.
And Sabinsa, a longtime developer and supplier of branded ingredients, has had a bacillus coagulans strain of its own called LactoSpore on the market for a number of years (the species has also been known as lactobacillus sporogenes). Recently the company announced the placement of the ingredient both in a national self-serve frozen yogurt brand as well as a bread sold in Colombia. It is part of planned push into the foods realm, according to Shaheen Majeed, marketing director for Sabinsa.
“A few years ago, after receiving self-affirmed GRAS, we began working with several marketing companies to bring out functional foods with LactoSpore,” he said. New applications are under development, Majeed said.
According to Nebraska Cultures, ProDURA’s stability shows no loss in potency at room temperature for three years and is highly resistant to stomach acid and bile. It survives at temperatures up to 100°C with almost no loss in potency, so it can be used in processed food, softgel and gummy applications; and can even be stable for various applications at 200°C or more. With stability at both very high and low pH conditions, ProDURA can deliver higher counts to the digestive tract, the company said.
With new research on the human microbiome, especially in the arena of enterotypes, the question becomes, which of the many strains of probiotics perform best? Should suppliers stick to strains that are already present in the gut? Are bacillus coagulans strains already represented in the human microbiome?
“The bacillus strains are pretty much all transient strains. They don’t really take up residence in the gut. But that’s true of a lot of probiotic strains,” Shahani said. That’s why consistent supplementation is necessary. Research has indicated that while addition of probiotics can alter the population numbers of different probiotic species in the human gut, the microbiome tends to return to a pre-intervention state after supplementation ceases.
Strain specific science
As in the discussion of any probiotic, strain specific science is paramount. Even though all the bacillus coagulans strains share common characteristics, such as their spore-forming life cycle, they can vary widely in other ways, such as temperature and pH tolerance ranges.
“The big difference between BC30 and the other spore formers on the market is we invest tens of millions of dollar in strain-specific science,” said Mike Bush, vice president of Ganeden. Shahani said there were some studies (beyond the stability studies) on the strain offered by Nebraska Cultures, though this science had not been conducted by the company per se.
Nebraska Cultures has an exclusive contract manufacturing arrangement with an overseas manufacturer to supply the ingredient, Shahani said. The company is most known for its Lactobacillus DDS 1 strain, the special strain of lactobacillus acidophilus that was isolated by Shahani’s father, the late Dr. Khem Shahani, at the University of Nebraska in the late 1950s. Generally, when working with bacillus coagulans, Shahani said, a separate, dedicated facility is required to avoid cross contamination with other strains.