The Californian-based biotechnology company was granted Current Good Manufacturing Practice (cGMP) certification for its manufacturing facility which produces silver dihydrogen citrate (SDC) concentrate as an Active Pharmaceutical Ingredient (API).
SDC is an electrolytically generated source of stabilized ionic silver which has been shown to have antimicrobial action. The ingredient is currently manufactured for use in disinfectant products and as an active ingredient, additive or preservative for inclusion in third party products, but is now being explored for its use in pharmaceuticals.
"This [certification] is a necessary step for PURE to be able to fulfill our requirement to provide SDC as an Active Pharmaceutical Ingredient to our current and prospective pharmaceutical development partners," PURE Bioscience president and chief executive Michael Krall said in a statement.
"Establishing the cGMP facility and production processes ensures that we meet the highest industry guidelines for the safety and quality of our API product."
The company had previously outsourced the API manufacturing, but with the company's pharmaceutical programs progressing it was "necessary and economically prudent" to manufacture SDC in-house, PURE spokeswoman Donna Singer told US-PharmaTechnologist.com.
The 13,500 sq ft. facility currently manufactures SDC concentrate and SDC-based disinfectant products for non-pharmaceutical uses, but has a current capacity to produce 550,000 gallons of API SDC annually.
The first US Food and Drug Administration (FDA) New Drug Application filed for an SDC hand sanitizer was submitted earlier this year and the company has several applications expected to be submitted over the next two years, including products for athlete's foot, onychomycosis (nail fungus), bacterial vaginosis, acne and wound care.
SDC is colorless, odorless, tasteless, non-caustic and formulates well with other compounds. It has been shown to have superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it, Singer said.
The product also offers 24-hour residual protection against standard indicator bacteria.
SDC is manufactured using a patented, proprietary process of electrolytically generating silver ions and complexing the ionic silver with an organic acid.
Manufacturing of the API will commence following regulatory approvals.
PURE has completed the Registration of Drug Establishment with the FDA.
A facility with cGMP production certification is recognized as having proper equipment, technical expertise, controls and procedures to produce API for human applications.