Knowledge Management in the biotechnology industry is an important buzz word right now. It is recommended by regulatory agencies (FDA, ICH) and is the focus of industry collaboration groups (BioPhorum). The BioPhorum BioManufacturing Technology Roadmap has a Knowledge Management path. This group has collected and communicated many important benefits and requirements for good knowledge management. However, while these resources have great definitions of what knowledge management is and how it can improve your company, there is still a general lack of HOW to improve knowledge management.
Knowledge Management is a HUGE topic. There are so many aspects of the biotech product/process development and manufacturing. How can all these aspects be captured and made to work together to increase overall knowledge management? How can we get to the wisdom and insight on the data/information/knowledge pathway? Defining the HOW of knowledge management gets quickly overwhelmed by the shear size of the problem (especially for companies with 10+ years of information to deal with).
In software development, the Agile mindset focuses on iterative development, failing fast and learning fast, working across departments to produce the highest quality products. A minimum viable product (MVP) is a version that has just enough features to be useable and provide value. Users can then provide feedback on the MVP and its future features.
Getting to the HOW of Knowledge Management will need to follow a similar mindset. By focusing on the most impactful knowledge gaps first, companies can gain immediate value and incrementally build toward a system that can handle ALL of their knowledge. By breaking up Knowledge Management into smaller bites, the problem becomes less overwhelming.
From BioPhorum KM document:
- Key benefits of a strong knowledge management system
- Cost – efficient manufacturing process, fewer errors, and reduced cost of supply/development
- Speed – reduce time to release product and time to introduce changes to an existing process
- Quality – increases capability to understand how CPPs impact CQAs, improves control, and reduces the occurrence of manufacturing out-of-specification product
References: Biomanufacturing technology roadmap – Knowledge Management, Dixon et al, BioPhorum, 2017