It all starts with having a specific strain, Bush said. The low end of the probiotics space is filled with distributors pushing generic strains. While what the ingredients these brokers sell might in fact be the correct genus and species, just going for the cheapest lactobacillus as an example is not serving the consumer, Bush told NutraIngredients-USA during a recent tour of the company’s Mayfield Heights, OH headquarters and lab. Probiotic organisms can vary so widely on a genetic basis that one strain can’t be called upon to perform the work of another. And in many cases the generic ingredients on the market might contain a mix of strains, Bush said.
“It’s about the strain, it’s not about the genus and species. Humans have closer similarity to chimpanzees than one strain of bacillus might have to another,” he said.
“Customers need to understand that so that they are not buying a generic strain that might have no functionality to it.”
100 year history
Bacillus coagulans is not a newcomer to the probiotic scene; it was first identified as an individual organism in 1915 at the Iowa Agricultural Experiment Station associated with the coagulation of evaporated milk. Ganeden’s patented strain is identified as GBI-30, 6086, a gram-positive, lactic-acid forming bacterium. The organism is unique among probiotics in that it forms spores when in a dormant state, which greatly improves the flexibility of the organism from formulation, shipping and shelf-stability standpoints.
From the start, Ganeden had a strong commitment to the science backing its ingredients, said David Keller, vice president of scientific operations. The company has 18 published studies on its specific strain, including the most recent study conducted at the University of Reading in the UK showing the ingredient supports gut and immune health in a healthy population of seniors. That study helped work around one of the sticking points in gut studies, namely that they tend toward disease end points in their design.
“We’ve done a lot of work around BC30 in general and have shown that it supports digestive and immune health,” said David Keller, for Ganeden. “But how do you study digestive health in a healthy population? It has been something that the industry has been struggling with and there really isn’t a good model out there as of yet.
“We chose a senior population that has had a decline in their general digestives and general immune health. Not because of any disease conditions but generally just due to aging. It was an ideal population to study,” he said.
After developing the science behind the organism for almost a decade, the company sold the supplement rights to Schiff Nutrition, now part of Reckitt Benckiser. Ganeden is paid a royalty on the sales of GanedenBC30 in supplements, which is now a very welcome part of the bottom line, Bush said.
Functional food applications
It was the organism's stability and formulation flexibility that led Ganeden to concentrate on the functional food market, Bush said. The organism can stand harsh processing and even the heat of baking. And it has very specific germination conditions, which include a fairly lengthy period above 30 degrees C (86 degrees F) with appropriate pH and moisture levels. This has allowed Ganeden to place it in a wide variety of foods, including baked goods, beverages, soups, nutrition bars and even gums.
Adding the ingredient into a capsule is fairly straightforward from a manufacturing standpoint. But putting it into food is another matter altogether, and requires a lot more support from the manufacturer, Bush said. It was a big part of the reason that Gandeden invested in a state-of-the-art lab at its Ohio headquarters to help customers with formulation and contamination challenges. The lab includes automated equipment that can almost instantaneously identify and count GanedenBC30 colonies on a plate, eliminating the time consuming (and possibly error-inducing) process of counting the colonies by hand. GanedenBC30 colonies have a very distinctive morphology as they grow, which eases the process.
FDA GRAS status
That commitment to quality was borne out in the no objection letter the company received on its GRAS notification to FDA in 2012, Keller said. Ganeden said its strain is the only bacillus coagulans ingredient that has achieved this level of GRAS. The typical no objection letter is usually a page or a page and a half, he said. But FDA’s response to Ganeden ran to four pages, and recounted some of the key features of Ganeden’s initial application. While FDA never comes right out and praises something, it did seem to acknowledge the thoroughness with which Ganeden in its initial submission laid out its quality controls during the manufacturing of the ingredient.
“It was as if they were saying these are the things they really liked about our submission,” Keller said.
"Giant companies won't work with self-affirmed GRAS ingredients," Bush said. "So we felt it was worth the many millions of dollars it took to get it."
Bush said the company’s commitment to the performance of the ingredient at the consumer level is also enshrined in its contracts with its customers. Efficacious doses are specified. For GanedenBC30, 1 billion CFU per day is the daily dose that supports gut health claims, while 500 million CFU supports immune health claims, Bush said. And those levels are far below the safety limit, which is set at 94 billion CFU, he said.
“We have stopped customers form launching products because they either couldn’t or were unwilling to put in an efficacious dose,” Bush said.