PALO ALTO, Calif., March 27 /PRNewswire/ -- Genencor International, Inc. announced today a European Notified Body has assessed and certified the first enzyme technology designed specifically as a prion disinfectant for medical devices. Prions, the causative agents of Bovine Spongiform Encephalopathy (BSE) and its human form, variant Creutzfeldt-Jakob Disease (vCJD), have been a concern in countries like the United Kingdom in recent years due to a lack of technology to reduce the risk from the protein-based particles on medical instruments. Developed jointly with the United Kingdom's Health Protection Agency (HPA) and independently certified for use by a European Community Notified Body, Prionzyme(TM) carries the CE mark (Conformite Europeenne). The product can be used to disinfect medical instruments utilized in invasive surgeries, such as procedures related to the central nervous system, eyes and tonsils, where prions have been shown to accumulate in the body. Genencor plans to further develop its Prionzyme line of products targeted for disinfecting general instruments and for sanitizing equipment for the meat processing industry.
Enzymes are proteins that help a chemical reaction take place specifically, quickly and efficiently and offer a number of advantages over traditional harsh and caustic chemical disinfectant methods such as reducing worker safety issues and are environmentally friendly and simple to use. With the launch of Prionzyme, hospitals and sterilization units now have access to a new, highly efficient technology to help them reduce the risk of prion contamination.
"Using the tools of biotechnology to address important issues facing the world today, Genencor is very pleased to commercialize the first enzyme technology to target this unconventional, infectious agent," said Thomas Pekich, president of Genencor. "Our partnership with the HPA combined with the protease technology expertise we've built over the past two decades has been key to addressing this difficult problem."
The use of Genencor's Prionzyme for medical instruments combines the proprietary enzyme with temperature and pH conditions. The product is added as the first step in a presoak process with stainless steel instruments. "This technology will be easily adaptable to current procedures and equipment already in place in hospitals and clinics," said John Gell, vice president, Industrial Specialties for Genencor. "Prionzyme also offers a number of benefits including minimizing worker safety issues by reducing exposure to harsh chemicals; lessening the environmental impact as enzymes biodegrade in disinfectant solution versus concern about disposal of caustic chemicals and providing material compatibility where proteases have been used in conjunction with stainless steel and other components for decades. We are now identifying marketing partners to bring the technology to the medical industry quickly and effectively."
Prionzyme M, the first enzyme from the new line of products, carries the CE mark indicating that the protease conforms with the essential requirements established by the European Medical Device Directive 93/42/EEC. Genencor plans for its additional Prionzyme products to also carry the CE designation. Genencor also recently received the ISO 13485:2003 registration at its Cedar Rapids, Iowa production site, where the Prionzyme products are manufactured. Following an extensive audit of the site's quality systems, Lloyd's Register Quality Assurance, a leading International Standards Organization (ISO) registrar and European Community Notified Body, awarded the ISO 13485 certificate of registration.
For more information about Prionzyme enzymes, contact Genencor at +1-800-847-5311 (USA only) or +1-800-256-5200.
Genencor International, a division of Danisco A/S, is a leading industrial biotechnology company that develops innovative enzymes and bioproducts to improve the performance and reduce the environmental impact of the cleaning, textiles, fuels and chemicals industries.