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On-line process tools, improved sensor calibration and analytical and data analysis methods are among the technological challenges facing the biomanufacturing industry over the next 10 years to greatly increase manufacturing efficiency for protein drugs while ensuring safety, according to industry, government and academic experts.
The analysis was developed during a special brainstorming session as part of the annual meeting of the International Foundation for Process Analytical Chemistry (IFPAC) held at the end of January. Representatives from the National Institute of Standards and Technology (NIST), the National Institutes for Health (NIH), the U.S. Food and Drug Administration (FDA) and the Massachusetts Institute of Technology (MIT) co-chaired a session to develop a vision for the future of biomanufacturing that attracted representatives from pharmaceutical companies, vendors, academia, research and development labs and other interested parties.
These improved measurement standards and technologies are essential initial steps towards the group's "blue sky vision" for the future of biomanufacturing. In this vision, bioreactors will mimic the cellular signaling and regulation systems of higher order living systems by regulating nutrients and waste with built in mechanisms to allow real-time analysis and control of fermentation, monitor metabolism and impact of variables within the system.
The group detailed some of the challenges facing the industry over the next 10 years and announced their intention to stimulate discussion and cooperation among stakeholders, including the federal government, academia, and research interests, as a way to address those technological and scientific hurdles.
The team also planned future sessions for the rest of the year, including conferences and site visits scheduled for the summer and fall of 2008 and further workshops to set research priorities during the fall of 2008. To read the full report, see IFPAC 2008: A 10 year Vision for Biotechnology Manufacturing Session.