Biotech firm ImmuCell Corp. of Portland has completed construction on a $20 million, pharmaceutical-grade factory that could help reduce the amount of antibiotics used in the dairy industry.

The facility is designed to produce nisin, an antibacterial peptide that ImmuCell plans to sell in purified form as a natural alternative to antibiotics for treating a disease that afflicts lactating dairy cows.

If ImmuCell succeeds in obtaining U.S. Food and Drug Administration approval, the product would give it a competitive edge in the bovine health industry. Completing the production facility is a major step toward obtaining that approval.

“This is a significant milestone on a project worth over $20 million,” said Michael Brigham, ImmuCell’s president and CEO. “We are right on the planned timeline and within a few percentage points of the dollar budget.”

The 43-foot-tall, 16,000-square-foot nisin plant took about 13 months to build, Brigham said. It is located next to ImmuCell’s headquarters building at 56 Evergreen Drive in Portland.

Now that the facility is completed, ImmuCell can finalize the installation of equipment and begin producing test batches of nisin to submit for FDA approval, he said. Brigham estimated that the company still has about two years to go before it could sell the product commercially.

“In the middle of 2018, we’ll make our first submission (to the FDA),” he said.

Betsy Williams, vice president of manufacturing operations at ImmuCell, gives a tour of its new facility Monday. Staff photo by Ben McCanna

ImmuCell plans to produce nisin via a fermentation process that uses a proprietary strain of bacterium. It then would be purified and concentrated to a pharmaceutical grade.

The new production facility’s interior looks like a cross between a pharmaceutical lab and a brewery, with giant steel tanks that will be used for fermentation, filtration and purification. Some areas are built to be International Standards Organization-certified cleanrooms, with strict air-filtration and cleanliness standards.

ImmuCell vice president of manufacturing operations Elizabeth “Betsy” Williams will oversee the process of producing test batches of nisin, analyzing them and submitting results to the FDA.

Once approved, the product would be sold as a treatment for mastitis, an inflammatory disease of the breast tissue, which can afflict lactating dairy cows. Existing antibiotic treatments render the milk unsalable temporarily, causing a loss of revenue to the farmers.

ImmuCell’s product would be different because nisin is a naturally occurring substance that already is approved for use as a food preservative in the U.S. Milk from cows being treated with nisin still could be sold. The close link to human consumption prompted the need for prior FDA approval.

ImmuCell originally planned to call the product Mast Out, but it dropped that name after the FDA expressed concerns that it would lead customers to believe the product prevents mastitis, which is not its function.

The process of obtaining FDA approval is a new challenge for ImmuCell, which has 45 employees. Once the company begins production, it would take about 10 people to operate, some of whom would be new hires.

The company’s flagship product, First Defense, which boosts newborn calves’ immunity to intestinal infections, was subject to less-stringent U.S. Department of Agriculture approval because newborn calves are not immediately consumed by humans after taking the product.

Building the nisin plant was a complex project that involved more than 30 specialty subcontractors working under the direction of general contractor Consigli Construction Co. of Portland, Brigham said.

Consigli project superintendent Stacey Harris said her company has led the construction of pharmaceutical facilities in the Boston area, but she said such projects are unusual in Maine.

“We have a lot of experience in Cambridge doing pharmaceutical buildings,” Harris said. “We’re excited to see something like this coming to Maine.”

ImmuCell, one of only three non-bank publicly traded companies in Maine, used a variety of methods to finance the nisin facility’s construction, including a public offering of shares in February 2016 that raised $5.9 million, and subsequent call for $3.5 million in private equity investment in October 2016.

The company also was awarded $375,000 in tax increment financing from the city of Portland to help offset future operational costs.

ImmuCell is hosting a ribbon-cutting ceremony for the new facility at 11 a.m. Wednesday with local and state officials. The ceremony will be open to the public and will include tours of the building, which is at 33 Caddie Lane.

J. Craig Anderson can be contacted at 791-6390 or at:

canderson@pressherald.com

Twitter: @jcraiganderson

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