The biopharmaceutical industry is regarded as a knowledge industry. However, in general, the industry is not effective at managing its knowledge as an asset across the product lifecycle, including during fundamental processes such as technology transfer. This is true in particular for tacit knowledge (e.g., know-how), where tacit knowledge it considered critical to the success of technology transfer, yet tacit knowledge transfer is somewhat ineffective. This can lead to the introduction of risk and other undesirable outcomes. This paper profiles a case study in tacit knowledge flow where a series of pragmatic practices were deployed during a complex vaccine drug substance technology transfer. These practices demonstrated improvements in tacit knowledge flow as evidenced by learning, process improvements and gaps in knowledge identified, which were subsequently addressed to reduce risk, increase product and process understanding, improve robustness, and define future development needs. Common success factors for these simple practices are explored through the case study. A key takeaway is that such knowledge transfer processes do not need to be complex nor onerous in order to achieve tangible improvements in knowledge transfer effectiveness.



Creative Commons License

Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.



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