OSIsoft & Broadley-James

OSIsoft announced August 16 that it has signed an Original Equipment Manufacturer (OEM) agreement with Broadley-James that will enable the analytical instrument manufacturer to bundle OSIsoft's OEM Historian technology with its BioNet reactor product line for pharmaceutical and biotech/life sciences manufacturing applications. The agreement supports the Food and Drug Administration's (FDA) Process Analytical Technology (PAT) Framework, which establishes guidelines to incorporate and integrate accurate data throughout the pharmaceutical manufacturing lifecycle, from research and development to production and back again. Enables Integrated Tech Transfer Between R&D and Production Data Broadley-James' BioNet reactor product line (20-liter vessel is pictured at right) is used in the pharmaceutical and biotech industries to develop and test drug recipes for production at pilot plants on a small scale prior to full-scale manufacturing. Such activities help manufacturers prepare for scaleup of new compounds by determining what factors impact the growth and behavior of cells within the bioreactors. The bioreactor itself includes a controller as well as a utility tower with the instrumentation, pumps, motors, sensors, valves, and meters necessary to monitor and control parameters such as pH, dissolved oxygen, temperature, level, gas flow and agitation. The data from various sensors inside the bioreactor provides insight into how the recipe behaves under various conditions. The OEM Historian from OSIsoft captures data from automated control systems within a pharmaceutical or biotech plant and transforms that data into instant intelligence. By incorporating the OSIsoft technology with the bioreactors, Broadley-James will deliver an R&D solution that enables supervisors and operators to compare research studies with actual production runs. This tech transfer helps enhance quality into drug design by feeding results back into research and development, consequently speeding up process understanding, better quality products and scaleup. "With this OEM agreement, we continue our commitment to the pharmaceutical industry and continue to expand our ecosystem of partners," said Matt Miller, who leads OSIsoft's OEM business development. "Manufacturers are seeking ways to have quality by design in their products, and this agreement will help them do that." "The ability to integrate online production data with offline lab data puts more information in the hands of operators," said Larry West, vice president of business development for BioNet, "and used effectively, brings better decisionmaking at all levels, from operators to supervisors." Broadley-James Corp. contact information:19 Thomas, Irvine, CA 92618 USA Phone: 1-949-829-5555Toll-Free: 1-800-288-2833E-Mail: [email protected]Website: www.broadleyjames.com