biospectrumasiaNovember 09, 2017
Tag: ImmuCell , Michael Brigham
Portland biotech firm ImmuCell completes $20 million expansion The 43-foot-tall, 16,000-square-foot nisin plant took about 13 months to build
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.
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.
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