The Massachusetts-based biotechnology company announced Monday [February 18], that it received a generally regarded as safe (GRAS) designation for its single-cell protein feed ingredient, KnipBio meal. The protein ingredient is reportedly the first of its kind to gain a GRAS designation in the US for use in aquafeed.
The GRAS certification permits the use of the protein ingredient in feeds for salmonids and other species of finfish, said the company. It was awarded by the US Food and Drug Administration (FDA’s) Center for Veterinary Medicine.
The change in status is an exciting step for the company, said Larry Feinberg, CEO with KnipBio. The recognition helps establish a path for other approvals of novel ingredients in the future.
“It’s rewarding for us as a company, and it helps set the precedent,” he told us. “This is the first one approved in the US, and presumably won’t be the last one.”
“There will be a path forward for the next technologies and the next proteins that come online,” he added.
Previously, it would have been challenging for producers in the US to use the single-cell protein, but the change in status allows for its adoption as a feed ingredient, he said.
The recognition is a “milestone” for KnipBio as several countries consider an FDA GRAS designation an indication that a feed ingredient has been “tested and reviewed,” Feinberg added in a release.
“Our GRAS designation now cements KnipBio Meal as a leading protein complement to fishmeal,” he said. “This milestone also provides us with opportunities to broaden industry access to our products, while eliminating any concerns about their safety and efficacy. For the first time, US aqua feed manufacturers will have access to a sustainable and affordable fishmeal replacement made from a traceable single cell protein.”
KBM’s approval process
The designation change followed a review of feed trials by an independent panel, the company said. The group sought to establish that the feed ingredient was safe for use in finfish diets.
The recognition from the FDA also brings a “validated sense of safety,” for customers, Feinberg told us.
To achieve the designation the protein product had to traverse a lengthy process of regulatory oversight, he said. “It’s different than my saying, ‘It’s safe because I said so,’” he added.
KnipBio also is in the process of expanding the approved use of its protein ingredient, he said. Adding, “Those will build off the foundation that this sets.”
In addition to use in finfish diets, the company is looking to have the protein ingredient approved for use in crustacean feeds along with having alternative versions of feed ingredient recognized – including strains that provide astaxanthin.
The company first met with officials from the FDA to discuss KBM in 2014, said Feinberg. From that stage, the company had to create and provide a dossier about the product, which, once submitted, took multiple months to evaluate.
However, the company also experienced some delay in the review during the partial government shutdown, he said. “There’s a call to figure out how to do this better as a community,” he added regarding the ingredient approval process.
Past research trials and company expansion
KnipBio previously tested KBM in the diets of several aquaculture species as a potential replacement of fishmeal.
In December, the company shared results looking at using the ingredient in the diets of juvenile rainbow trout. The feeding trials compared the use of the single-cell protein against poultry meal, fishmeal and soy protein concentrate.
At the time, the ingredient was found to out-perform poultry meal and soy protein concentrate, the company said. Compared to fishmeal use, KBM was found to support similar fish growth and feed efficiency when added at up to 15% of the total diet.
The company also has been working to expand production levels and is currently in the process of scaling to a 200,000L production facility, according to company information. As part of that ongoing effort, KnipBio signed a JDA with the Kansas-based engineering company ICM in April of 2018.