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Monsanto Gets Regulatory Approval for Hormone Production at Augusta, Ga., Plant

Posted on: Tuesday, 21 March 2006, 00:00 CST

By Tony Lombardo, The Augusta Chronicle, Ga.

Mar. 21--St. Louis-based Monsanto Co. announced Monday it has been given regulatory approval to produce its milk-boosting hormone for dairy cows, a product called Posilac, from start to finish at its east Augusta manufacturing plant.

"It's a good day at the plant," manager Rod Denton said. "We're actually in full production." The facility on Lovers Lane has produced a powder form of Posilac since 2003. Until last week, however, the plant did not have Food and Drug Administration approval to complete the process.

Instead, Monsanto shipped the powder to an Austrian company, Sandoz GmbH., which converted the product to a gel and inserted it into syringes before sending it back for distribution to U.S. dairy farmers.

With FDA approval Friday, Monsanto is cleared to do all the processes at the Augusta plant, which has 210 employees and 30 contract workers.

The new production line does not mean new hires, but the 200,000-square-foot plant has the capability for expansion, Mr. Denton said.

Prior to approval, employees were trained on the syringe-filling operation and all equipment was in place. The FDA needed to see the process in action before approving it, Mr. Denton said.

Monsanto now will be able to meet the high demand for the hormone, spokesman Andrew Burchett said.

Supply for Posilac, the trade name for the company's recombinant bovine somatotropin, has been low since 2004 because of production problems at the company's Austrian partner.

That year, the FDA investigated the facility after nine batches of contaminated product were discovered. None of the contaminated batches made it to market.

Currently, Monsanto only has enough supply to meet the needs of its existing customer base, Mr. Burchett said.

"Monsanto's Posilac business will be able to grow once supply is no longer a limiting factor, and Augusta's plant is a big role in that," he said.

Monsanto still has plans to work with Sandoz because of the high demand, Mr. Burchett said.

Monsanto's contract with Sandoz is due to expire Dec. 31, 2008, though Mr. Burchett said, "We expect to reach some resolution with them."

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Copyright (c) 2006, The Augusta Chronicle, Ga.

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MON,

Source: The Augusta Chronicle

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