ImmuCell prepares for nisin manufacture

Process validation and optimization to complete manufacturing objectives started regulatory submission on nisin-based mastitis treatment.

ImmuCell Corp., a growing animal health company for the dairy and beef industries, announced July 9 that it has completed modifications to its manufacturing facility to produce pharmaceutical-grade nisin, the active ingredient in its Mast Out product, to address subclinical mastitis in lactating dairy cows.

ImmuCell will commence validation and testing of the new facility and processing equipment to complete the manufacturing requirements of the new animal drug application (NADA) submission to the Food & Drug Administration.

Once these data have been compiled, the company expects to make its first submission of the Chemistry, Manufacturing & Controls (CMC) Technical Section to FDA around the end of calendar year 2014.

At the same time, company scientists are working with FDA to transfer the analytical method to detect nisin in milk to an FDA laboratory. Once this method is successfully transferred, the company expects to receive the Human Food Safety Technical Section Complete Letter from FDA.

ImmuCell anticipates two, six-month reviews of the CMC Technical Section submission by FDA during 2015, setting up potential NADA approval from the FDA during 2016. This would allow test marketing of Mast Out in 2016.

ImmuCell president and chief executive officer Michael F. Brigham said, "We are pleased with the progress achieved during the first half of fiscal 2014 in completing the necessary modifications to our manufacturing facilities on time and on budget. We will now begin to utilize the newly installed equipment and space to demonstrate to FDA our ability to effectively produce pharmaceutical-grade nisin while verifying process yields."

Mastitis is considered the costliest disease to the U.S. dairy industry and major dairy producing regions of the world. Annual losses are presently estimated to be upwards of $2 Billion in the U.S. alone. These losses are comprised of reduced milk production, discarded milk, replacement animals, labor, drug treatments and veterinarian services.

Mastitis refers to an inflammation of the udder, most commonly caused by a bacterial infection. This infection is commonly treated with traditional antibiotics. Mast Out, an intramammary infusion product containing nisin, is under development as an alternative to traditional antibiotics for the treatment of subclinical mastitis in lactating cows. The safety profile of nisin may allow for the use of Mast Out in the U.S. without "milk discard" or "meat withhold" requirements.

In late 2013, the company announced a $3 million capital improvement investment, allocating approximately half of this total to build out modifications of its facility and acquire equipment necessary to produce pharmaceutical-grade nisin. The remaining amount has been allocated to a 7,100 sq. ft. facility addition intended to increase production capacity for current products, maintain compliance with current good manufacturing practice regulations in all operations and integrate the production of pharmaceutical-grade nisin. The company is preparing to break ground on this second project during the third quarter of 2014.

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