Biopharmaceutical Product and Process Knowledge Management

The American Productivity & Quality Center (APQC), a world-leading authority in knowledge management (KM), defines KM:

The application of a structured process to help information and knowledge flow to the right people at the right time so they can act more efficiently and effectively to find, understand, share, and use knowledge to create value.

For biopharmaceutical producers, creating value from the knowledge capture and dissemination is paramount. At the upcoming February 23-26 IFPAC [International Foundation Process Analytical Chemistry] conference, Emerson’s Michalle Adkins will present on the impact of KM in product and process development for biopharmaceutical manufacturers.

She will discuss some of the large barriers in successfully executing KM practices. These include traditional organizational silos, massive quantities of data, manual handoffs & workflows, disparate systems and more.

Technology is advancing to offer some capabilities to address these barriers. One example Michalle will discuss is how digital blueprinting of the lifecycle can be used for KM and regulatory compliance. Other technology advancements are in the areas of analytical insights/process analytic technology (PAT), greater recipe flexibility, recipe transfer across product development lifecycle, and easily added plug-and-play sensors and analyzers.

Common KM tools include communities & networks, content management, effective taxonomies, lessons learned, expertise location, and knowledge transfer & retention through knowledge mapping. Knowledge mapping is a method to measure the flow of knowledge within a process and helps identify what is tacit versus explicit knowledge.

Drug development phases and increasing production scaleThe challenge is to incorporate these technologies into a KM approach to accelerate the pipeline from clinical to approval. Today, much of the knowledge required to accelerate this technology transfer pipeline is tacit knowledge, gained from experience but not easily accessible to be used forward in the pipeline in bringing a product to market nor back from commercial production to the development stages.

The complexity of the recipe transfer process is becoming more automated as recipes get transferred from drug development pipeline stage to stage. Key to this acceleration is:

  • Flexible recipe design and execution across scales
  • Modular and flexible building blocks
  • Centralized recipe management tools
  • Product lifecycle change management integration
  • Knowledge capture throughout the product lifecycle

From a knowledge management perspective this means to create modular, flexible process definitions, to provide a more seamless critical attribute exchange with the execution systems, and an effective electronic management of change process.

If you’ll be at IFPAC 2020 in North Bethesda, Maryland, make sure to catch The Future is Now: Advancing Data, Information and Knowledge Management in the Pharmaceutical Industry Track where Michalle will be presenting. If you can’t be there, visit the Life Sciences & Medical section on Emerson.com for some of the technologies and solutions that can be used to help accelerate your product development pipelines and knowledge management initiatives. You can also connect and interact with other pharmaceutical and biotech industry experts in the Life Sciences group in the Emerson Exchange 365 community.

Posted Wednesday, February 12th, 2020 under Life Sciences & Medical.

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