ImmuCell Corp., a growing animal health company that develops, manufactures and sells products to improve health and productivity in the dairy and beef industries, announced Oct. 11 that it has broken ground on construction of its new pharmaceutical facility in Portland, Maine, to produce nisin — the active ingredient in its Mast Out product.
“Initiating the site construction phase of this extensive project is a key milestone resulting from over 15 years of investment in product development and production scale-up for this novel mastitis treatment for dairy cows,” ImmuCell vice president of manufacturing operations Elizabeth L. Williams said.
Stantec Consulting Services Inc. is providing design and engineering services. Consigli Construction Co. Inc. is serving as construction manager on this project, so in connection, ImmuCell entered into a guaranteed maximum price contract with Consigli valued at approximately $5 million during the third quarter. The company expects to amend this contract during the fourth quarter to increase the value to approximately $11 million.
“Through its construction and when it is complete, this facility will ultimately result in many local jobs,” Consigli project executive Dave Thomas said. “We are excited to be a part of something that will have a lasting impact on our community and will continue to contribute to the regional economy in such a significant manner for years to come.”
The two-story facility, which is being built near the company’s headquarters and a U.S. Department of Agriculture-licensed production facility in Portland, will provide more than 16,800 sq. ft. of fermentation, processing, laboratory and warehouse space on a footprint of 12,625 sq. ft. for the production of nisin. The estimated budget for this project is $20 million, with TD Bank N.A. providing debt financing for a portion of the cost.
Plans call for construction to be completed by the third quarter of 2017 and for equipment installation to be completed by the first quarter of 2018. Photographs displaying progress on the construction project will be posted periodically on the company’s website at www.immucell.com in the “What’s New” section.
To gain regulatory approval of Mast Out, validation batches must be produced, and a detailed Chemistry, Manufacturing & Controls (CMC) Technical Section must be prepared and submitted to the Food & Drug Administration. Additionally, it must undergo a successful site inspection. Allowing for two 6-month reviews of the CMC Technical Section by FDA, ImmuCell said it anticipates product approval in 2019.
The city of Portland approved a tax increment financing credit enhancement package for ImmuCell that reduces the company’s real estate taxes on this facility by 65% over the first 11 years and by 30% during the 12th year, after which the rebate expires. This financing is still subject to standard approvals by Maine’s Department of Economic & Community Development.