Effective Knowledge Transfer during Biopharmaceutical Technology Transfer - How Well Do We Do It?

Author’s Note: This is the author’s submitted manuscript which has subsequently been published in the Journal of Validation Technology (www.ivtnetwork.com, Volume 25, Issue 4 – August 2019). While knowledge management (KM) has been widely applied in other sectors, the international biopharmaceutical sector has struggled with the meaningful and sustained application of effective KM practices. This is evident even though KM has been highlighted in regulatory guidance for over 10 years, and the positive business impact of KM is well recognized in other sectors. This paper focuses on the topic of KM as applied to biopharmaceutical technology transfer, introducing new research that explores the importance and effectiveness of knowledge transfer as an integral component of a biopharmaceutical product technology transfer. Results from multiple sources explored in this paper are well aligned in recognizing that knowledge transfer is very important to enable technology transfer, yet the biopharmaceutical sector is not very effective at this knowledge transfer. This is especially true of tacit knowledge transfer which is often reported to be ineffective. Additional research will further define the barriers to improve knowledge transfer effectiveness and how the biopharmaceutical sector might improve in this area