A Clearwater manufacturing facility will be the production site for a potential treatment for people who suffer from peanut allergies.
Aimmune Therapeutics Inc. (NASDAQ: AIMT), a biopharmaceutical firm headquartered in Brisbane, California, cut the ribbon Wednesday at the new plant on the ICOT Center campus of CoreRx, a contract development and manufacturing organization.
The facility brings about a dozen jobs to the area right away with more to come, while also helping grow the life science and biotechnology sector in Tampa Bay, a key goal for economic developers.
The new plant will produce AR101, Aimmune’s lead product, which is currently in Phase 3 international trials.
It’s a therapeutic approach designed to desensitize patients to peanut allergens and cut the risk of having an allergic reaction, or reduce the severity of the symptoms if a reaction occurs.
“When patients are exposed, they can end up with serious or life-threatening impacts and have to go to the emergency room,” said Jeff Knapp, chief operating officer of Aimmune. “Children in particular often have to go through important events in their life separated from others. They can’t risk exposure to peanut allergens. When they go to school or to a friend’s house, parents are concerned because they don’t have control.”
There are about 3 million people with peanut allergies in the United States, and another 3 million in Europe, Knapp said. More than 50 percent of them react to less than one-third of a peanut kernel.
The new facility includes a 5,300-square-foot commercial manufacturing suite, another 5,300 square feet for future manufacturing, a 2,000-square-foot multi-use clinical suite, and an 8,000-square-foot environmentally controlled warehouse. There are state-of-the-art air handling systems and equipment to prevent cross contamination and other controls to ensure safety and compliance with U.S. and European pharmaceutical manufacturing regulations.
There’s still work to be done at the plant to meet FDA standards, but by early 2018, the plant will operate with the capacity to manufacture up to 450 million capsules per year.