TY - JOUR T1 - Risk Management in Biologics Technology Transfer JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 596 LP - 599 DO - 10.5731/pdajpst.2016.006718 VL - 70 IS - 6 AU - Robert Toso AU - Jonathan Tsang AU - Jasmina Xie AU - Stephen Hohwald AU - David Bain AU - Derek Willison-Parry Y1 - 2016/11/01 UR - http://journal.pda.org/content/70/6/596.abstract N2 - 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. ER -