Wednesday, December 4, 2013

Focus on Manufacturing Culture

Today we feature an excerpt from our partners at BioProcessing International Magazine "Focus On… Manufacturing Culture," authored by Justin Neway.

Life sciences company leaders need to put the right people, processes, and technologies in place to create evolutionary cultures. Such cultures would embrace advanced manufacturing process intelligence and reap related business benefits. Since the late 1990s, my software company has helped biomanufacturers improve their process understanding. In that time, we’ve seen regulatory drivers such as quality by design (QbD) and process analytical technology (PAT) guidances call for improved manufacturing process performance through better process understanding and optimization. We define process intelligence as the technology and systems needed to design, commercialize, and sustain robust manufacturing processes that provide predictable high-quality outcomes cost-effectively based on scientific process understanding. Through our experiences, we see three key elements helping successful companies reach an advanced level of process intelligence: people, processes, and technologies. Combined correctly, those three components create a process intelligence culture that evolves through distinct levels of advancement. Drawing from “Management 101” lessons, we know that when our customers’ leaders foster cultural change by empowering people and leveraging the right business processes and technologies, organizations reap greater, measurable rewards, including risk reductions, faster times to market, and greater operational efficiencies. Business teams need to drive organizational change before information technology (IT) experts can implement solutions that are measured on their business value. 

Continue reading the article here.

This spring in San Diego, the Biopharmaceutical Development and Process Week will feature a track dedicated to Process Validation & Continued Process Verification featuring speakers from organizations and companies including University of Sheffield, Genentech, Lonza Biologicals and more. Download the agenda to find out more. If you'd like to join us, as a reader of this blog when your register online and mention code BLOG14JP and save 20% off the standard rate.

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