Company retrofits manufacturing facility for proprietary antimicrobial development
EL CAJON, Calif.-PURE Bioscience (www.pure-bioscience.com) has begun conversion of part of its manufacturing space here to a dedicated, FDA-compliant, cGMP facility for production of pharmaceutical-grade silver dihydrogen citrate (SDC).
The company's proprietary aqueous antimicrobial is an electrolytically generated source of stabilized ionic silver that is colorless, odorless, tasteless, and non-caustic. The company believes SDC shows promise as a broad-spectrum antimicrobial for human and veterinary healthcare products.
"As we move forward with testing and regulatory work on SDC for use in prescription and personal care products, we are required to produce silver dihydrogen citrate raw material in compliance with the FDA's current Good Manufacturing Practices,"; says Michael Krall, PURE Bioscience president and CEO. "Fortunately, the space required to produce SDC concentrate is small, so design and construction costs are economical."
Therapeutics Inc. (San Diego; www.therapeuticsinc.com) has assumed responsibility for funding and managing the testing and regulatory process for potential FDA-regulated products. The company is focusing on development of SDC-based products for the treatment of bacterial, viral, and fungal-mediated diseases and conditions-beginning with women's health and acne treatment products.
PURE Bioscience has already secured Environmental Protection Agency (EPA) registration for its 2400-parts-per-million technical-grade SDC concentrate under the trade name Axenohl, as well as for its Axen and Axen 30 hard surface disinfectants. III