Software Platform for Quality by Design Implementation.
Bend, OR (PRWEB) December 24, 2008
Blue Reference, Inc., a leading developer of process analytics software, has officially announced the formation of the Quality by Design Product Development Consortium (QbD PDC). Blue Reference will work in cooperation with participating global pharmaceutical development and manufacturing companies to identify and develop methods for planning, execution, and management of Quality by Design (QbD) principles in pharmaceutical research and development. A roadmap for the QbD PDC project can be found at http://www.InferenceForQbD.com.
The QbD PDC was launched on the heels of recent steps taken by the Food and Drug Administration (FDA) to promote its Process Analytics Technology (PAT) initiative. PAT embraces the basic tenet of Quality by Design: To design and develop processes that consistently ensure manufacture end quality. Such processes reduce risks to regulatory concerns, increase drug product quality, lower manufacturing costs, and speed time-to-market.
"According to findings of the largest empirical study ever performed on the interplay of pharmaceutical manufacturing and the Food and Drug Administration (FDA), by postponing implementation of Quality by Design practices the pharmaceutical industry is, in effect, wasting more than $50 billion a year in manufacturing costs," said Paul van Eikeren, founder, President, and CEO of Blue Reference.
Through the QbD PDC, participating companies will leverage Blue Reference's expertise in process analytics software, while contributing their knowledge of regulatory workflow requirements, to determine cost-effective and reliable methods for achieving process understanding. These methods will be integrated into a comprehensive software solution for implementing QbD practices in pharmaceutical development. The QbD PDC will employ Blue Reference's novel Inference software platform (http://www.Inference.us) to efficiently prototype, develop and test QbD solutions at participating companies.
Van Eikeren added, "Through collaboration with several global pharmaceutical companies, Blue Reference is creating an umbrella software solution for Quality by Design that enables companies to substantially improve drug development productivity and timelines while reducing drug manufacturing costs and risks."
About Blue Reference, Inc.:
Blue Reference software and services power the discovery and application of knowledge; revolutionizing how scientists, engineers, technical professionals, and business professionals analyze data, design experiments, test quality, document results, and share information.
Blue Reference is operated by the founders of IntelliChem, which pioneered the use of Electronic Laboratory Notebooks for R&D in the world's largest pharmaceutical companies and is now owned by Symyx Technologies. Blue Reference's work in QbD is supported, in part, by the National Science Foundation Small Business Innovation Research program for the project entitled "Software Platform for Quality by Design Implementation."
For more information please visit http://www.BlueReference.com.
Contact: Ben Hinchliffe, (541) 350-3620 ext. 115, ben.hinchliffe at bluereference dot com.
Reference: J. Macher and J. Nickerson, 'Pharmaceutical Manufacturing Research Report: Final Benchmarking Report,' McDonough School of Business (Georgetown University) and Olin School of Business (Washington University in St Louis), September 2006.