The BioPhorum organization was formed in 2004 with the mission, “…to create environments where the global biopharmaceutical industry can collaborate and accelerate its rate of progress, for the benefit of all.”
Emerson’s Michalle Adkins alerted me to the release of a new BioPhorum Knowledge Management white paper, A Test Case in CMC Business Processes from Late-Stage Development to Commercial Manufacturing.
Here is its description:
The management of knowledge in biopharmaceutical organizations has been recognized as an important challenge over recent years. Defining the pain points and designing successful knowledge management (KM) solutions have proven difficult. To address this challenge, BioPhorum Technology Roadmapping applied a KM best practice methodology to capture a process-based knowledge map for a major business process; this was performed by companies who develop and commercialize new therapies. The resulting assessment of knowledge flows revealed that there are significant challenges to both explicit and tacit knowledge flow across the control strategy and method development / technology transfer processes. Some generalized solutions have been proposed. As part of this work, a detailed spreadsheet tool was developed so that organizations can repeat this work on their business processes to understand their knowledge–flow issues and develop fit-for-purpose solutions.
Michalle joined a team of biopharmaceutical industry professionals, consultants, OEMs, and BioPhorum staff members to develop best practices & tools to improve this flow of knowledge in the creation and commercialization of new therapeutics.
In the introduction section, the authors highlight the fact that KM is not only a strategic challenge unto itself, but also:
…can support the other five strategic challenges, such as in-line monitoring and realtime release, accelerating the adoption of new process technology and the automation of manufacturing (including better data capture and analytics).
Better managing knowledge requires an understanding of:
…how it flows through an organization. The value of knowledge is maximized when it is applied by the right person at the right time so they can deliver on the mission in hand.
In assessing knowledge:
…flow is a key step in better managing knowledge and maximizing its value by ensuring it is not just created, but used and reused.
The intent of this whitepaper is:
…to create some fundamental understanding of how to manage knowledge and to provide a practical tool to map knowledge–flow in the core business processes of the biopharmaceutical industry. By applying this tool, organizations can assess their knowledge–flow and uncover potential problems to be addressed.
There is no charge to register for and download this white paper. Read the white paper to learn more about guiding principles, knowledge mapping & map construction, and recommendations on finding, prioritizing and implementing KM solutions.
Visit the Life Sciences & Medical section on Emerson.com for more on the technologies and solutions to help you better capture, use and reuse the knowledge in your manufacturing processes. You can also connect and interact with other pharmaceutical and biopharmaceutical industry experts in the Life Sciences group in the Emerson Exchange 365 community.
