PT  - JOURNAL ARTICLE
AU  - Robert Toso
AU  - Jonathan Tsang
AU  - Jasmina Xie
AU  - Stephen Hohwald
AU  - David Bain
AU  - Derek Willison-Parry
TI  - Risk Management in Biologics Technology Transfer
AID  - 10.5731/pdajpst.2016.006718
DP  - 2016 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 596--599
VI  - 70
IP  - 6
4099  - http://journal.pda.org/content/70/6/596.short
4100  - http://journal.pda.org/content/70/6/596.full
SO  - PDA J Pharm Sci Technol2016 Nov 01; 70
AB  - Technology transfer of biological products is a complex process that is important for product commercialization. To achieve a successful technology transfer, the risks that arise from changes throughout the project must be managed. Iterative risk analysis and mitigation tools can be used to both evaluate and reduce risk. The technology transfer stage gate model is used as an example tool to help manage risks derived from both designed process change and unplanned changes that arise due to unforeseen circumstances. The strategy of risk assessment for a change can be tailored to the type of change. In addition, a cross-functional team and centralized documentation helps maximize risk management efficiency to achieve a successful technology transfer.