Knowledge mapping for the biopharmaceutical industry: A test case in CMC business processes from late-stage development to commercial manufacturing (paper and tool)

Many recognize that knowledge is crucial to the success of every business. The pursuit of knowledge appears to be relentless but often it is not curated, cataloged, retained or shared very well. And the ever-increasing digitization of information just means it is becoming more difficult to manage knowledge in an unplanned way effectively.

Truly understanding how to use knowledge and designing successful knowledge management (KM) solutions is difficult. This is why the BioPhorum Technology Roadmapping KM Workstream came together to develop the discussions in the Biomanufacturing Technology Roadmap knowledge management chapter . This chapter focuses on how KM impacts on biopharmaceutical working practices and to determine the best practice tools and approaches to minimize waste and maximize the utilization of knowledge assets. The result is the paper and supporting tool Knowledge Mapping for the Biopharmaceutical Industry: A Test Case in CMC Business Processes from Late-Stage Development to Commercial Manufacturing.

“Most of us don’t touch our products, we are knowledge workers,” said Robert Guenard, Senior Director – Manufacturing Sciences at Biogen, and an author of the paper. “I hope that people see knowledge as the asset it really is. I want organizations to use our tool to assess how they are doing, and then use this to meet the challenges and opportunities coming in the digital world.”

The paper shows how a clear KM approach can help businesses identify knowledge flows, assess the quality and criticality of those flows, and identify areas for improvement – and it demonstrates this through the familiar industry process of a manufacturing process and assay development.

It also discusses some high-level examples of how KM issues may be addressed using the principles of people, process and technology. The paper and tool allow organizations to repeat these KM assessments on their different business processes to understand their knowledge flow issues  and develop fit-for-purpose solutions.

Guenard suggests that businesses ask some big questions about their knowledge. “If this is our key asset, what framework do I use to look at knowledge in my organization, from creators to users, and the huge amount of tacit knowledge in people over the product lifecycle? How do we make sure that the energy and time people put in is captured in the enterprise?”

The risks of poor KM can be significant. A drug’s development could take longer because there’s a problem your organization has experienced before, but this wasn’t known and acted on for a current project. You may even waste time and money rediscovering something you’ve already invested in. These issues are exacerbated when staff leave and take their undocumented knowledge with them. However, the potential benefits of KM are extensive – if knowledge is treated as a critical asset. It can help increase the efficiency of a pharmaceutical enterprise, improve speed to market and lower the cost of drug development. Decisions will be made more quickly and with better information, and drug development will be faster with less physical experimentation when prior knowledge can be more effectively leveraged, particularly across products and/or platforms.

But if effective KM has so many benefits, why has it not been adopted more? Reasons include a lack of understanding of what ‘knowledge’ is and how it creates value, thinking that KM can be achieved through technology alone and because all knowledge does not have equal value but depends on its context. The BioPhorum paper discusses all of these issues and more.

Regulators already recognize KM as a critical enabler of a science- and risk-based approach to assuring the quality of medicines. For example, in International Conference on Harmonisation (ICH) guidance, KM has been highlighted as important in Pharmaceutical Development (ICH Q8), Quality Risk Management (ICH Q9), and Pharmaceutical Quality Systems (ICH Q10). This regulatory focus is only likely to increase and the BioPhorum paper and tool will help guide companies in developing a KM approach that will satisfy regulator concerns.

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