July 9, 2007 — TUCSON, AZ — BioVigilant announced on July 5 that it has hosted the first consortium meeting for Instantaneous Microbial Detection earlier last month at Amgen corporate headquarters in Thousand Oaks, CA. The meeting was initiated following strong interest from the pharmaceutical manufacturing sector to implement the Instantaneous Microbial Detection (IMD) technology into its environmental air monitoring systems. The
meeting was attended by representatives from 12 pharmaceutical and biotech companies including Alcon, Amgen, Bayer, DSM Pharmaceuticals, Eli Lilly and Company, Genentech, GlaxoSmithKline, Johnson and Johnson, and four others. Members presented results of testing of IMD instruments and discussed strategies to implement this exciting technology.
Dr. Michael J. Miller, Senior Research Fellow for Eli Lilly and Company and a globally recognized leader in rapid microbiological methods, states, “The technology platform being developed by BioVigilant has the potential for significantly enhancing the manner in which
the pharmaceutical industry will monitor and control our manufacturing environments. Furthermore, the ability to provide results continuously and in real time is aligned with the industry’s desire to adopt new technological advances and risk-based approaches that focus on process control strategies and scientific methods in order to meet patient requirements. These concepts are at the core of Quality by Design.”
Doug Rufino, senior director of lab services and analytical development for DSM Pharmaceuticals, notes, “The ability of IMD to provide real-time microbial detection will drastically change the landscape for aseptic training as well. It can be adapted to provide
immediate use for gown qualification and fill-line training on water-based fill-line trials in efforts to pin-point where viables are detected to immediately correct behavior. This of itself can make an enormous improvement in quality of aseptic operations as well as
significant cost-avoidance savings.”
Rainer Newman, executive director of technology of Johnson and Johnson, describes one of the key benefits of the technology: “Using the IMD apparatus as a PAT application will fundamentally change the way investigations into environmental excursions are conducted.”
Miriam Rozo, manager of microbiology from Johnson and Johnson, adds, “The IMD has the potential to provide for a significant cost reduction and quicker detection of shifts in the environment where sterile products are aseptically produced.”
“The gathering of so many thought leaders in the industry is wonderful testament to the interest that the IMD technology has generated within such a short period of time, and we are honored to have this opportunity to continue to strive to provide solutions to pharmaceutical manufacturers’ needs,” says Deward Manzer, BioVigilant’s CEO. “We have collaborated with our pharmaceutical manufacturer customers over the past two years and understand the demands they face internally as well as externally. For example, our technology fits extremely well in meeting the FDA’s PAT (Process Analytical Technology) initiative and will enable our customers to provide continuous, real-time results for their environmental quality assurance testing requirements.” Manzer briefly compares BioVigilant’s Instantaneous Microbial Detection capabilities with the current, conventional plate culturing method: “Our instrument can determine simultaneously for each particle the size of the particle and whether it is biologic or inert, indicating immediately to the user if there has been contamination. This is in contrast with the current method using culturing, which generally takes from two to seven days from test to results. During the waiting time for the current method, production can occur in a contaminated environment, which is detrimental and very costly to pharmaceutical manufacturers. BioVigilant’s instruments can help to reduce significantly, or, in some cases, even eliminate these problems.”
BioVigilant develops, builds, and maintains a family of environmental monitoring instruments for use in pharmaceutical manufacturing, military, homeland security, food processing, health care, and other applications. Through the novel use of Instantaneous Microbial Detection technology, BioVigilant’s scientists have created instruments with entirely new classes of functionality and unparalleled sensitivity and accuracy than had been possible using existing methodology.
BioVigilant vice president of marketing and sales
E-mail: [email protected]