RT Journal Article SR Electronic T1 Risk Management in Biologics Technology Transfer JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 596 OP 599 DO 10.5731/pdajpst.2016.006718 VO 70 IS 6 A1 Robert Toso A1 Jonathan Tsang A1 Jasmina Xie A1 Stephen Hohwald A1 David Bain A1 Derek Willison-Parry YR 2016 UL http://journal.pda.org/content/70/6/596.abstract 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.