ImmuCell Corp., an animal health company that develops, manufactures and markets products to improve the health and productivity of dairy and beef cattle, announced the completion of the construction phase of its nisin production facility in Portland, Maine, and said the installation of process equipment has progressed significantly.
A ribbon-cutting ceremony and facility tour will be held on Nov. 8. Maine Department of Agriculture, Conservation & Forestry commissioner Walter E. Whitcomb and other city of Portland officials are expected to attend the event.
“This is a significant milestone on a project worth over $20 million. We are right on the planned timeline and within a few percentage points of the dollar budget,” ImmuCell president and chief executive officer Michael F. Brigham said.
“We have come a long way since breaking ground in September 2016,” added ImmuCell vice president of manufacturing operations Elizabeth L. Williams, who is in charge of this project. “This would not be possible without the top-quality work performed by the multiple contractors that participated with us on the project.”
Financing for this project was provided by the company's stockholders and by TD Bank N.A.
The active ingredient, nisin, to be produced in this facility will form the drug substance for a novel treatment for subclinical mastitis in lactating dairy cows that can be administered without a milk discard or meat withhold requirement (which is a label requirement for traditional antibiotics on the market today).
ImmuCell said it expects equipment installation and qualification to be complete by year-end. Commercial-scale process validation batches must be produced, a detailed manufacturing technical section must be prepared and submitted to the Food & Drug Administration and successful FDA site inspections must be achieved.
The company anticipates making the first submission to FDA during the middle of 2018. It is expected that two submissions will be required, each subject to a six-month review by FDA. After approval of the manufacturing technical section comes a 60-day administrative review before product license approval can be issued. Adherence to this anticipated timeline could lead to potential approval by the end of 2019, with subsequent market launch.
ImmuCell's purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell has developed products that provide immediate immunity to newborn dairy and beef livestock and is developing a novel treatment for mastitis, which causes significant economic loss to the dairy industry.