Ophidian outfits pilot plant for antibody-based drugs

MADISON, WI – USING PROPRIETARY technology based on hen eggs and $2 million in financing, Ophidian Pharmaceuticals Inc. (Madison, WI) plans production of experimental antibody drugs that entered Phase II clinical trials in August.

The funds, provided by a company director and a shareholder in a private transaction, will outfit a leased facility in Madison for small-scale pilot manufacturing of the company's lead development drug, OPHD001.

The non-antibiotic product treats serious infections caused by Clostridium difficile, a bacterium that sickens some 350,000 hospital patients each year after they have been given broad-spectrum antibiotics, says chief financial officer Donald Nevins. The drug is a novel formulation of antibodies obtained from the dried yolks of hen eggs.

Scheduled to begin operation in November, the 10,000-square-foot pilot plant includes two HEPA-filtered rooms that meet Class 100,000 standards, two Class 100,000 dry product handling areas that were designed to meet Class 10,000 specs, and a Class 100 laminar flow area within one of the rooms.

The cleanrooms handle freezing, drying, blending and packaging of the bulk product material, which is then sent out to a contract manufacturer for final dosage formulation. The hens are housed indoors in a separate facility under USDA rules for raising the birds for meat or eggs.

The $2 million will purchase infrastructure improvements to the building and process equipment, according to Jay Jett, director of manufacturing. An additional 15,000 square feet is available in the leased building for commercialization of the product.

The plant will also manufacture clinical trial material for a second product derived from hen eggs. That product, which treats inflammatory bowel disease, is scheduled for toxicology studies and Phase I clinical trials next year.

Sheila Galatowitsch


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