RT Journal Article
SR Electronic
T1 Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test Runs
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 650
OP 657
DO 10.5731/pdajpst.2015.01087
VO 69
IS 5
A1 Sushil Abraham
A1 David Bain
A1 John Bowers
A1 Victor Larivee
A1 Francisco Leira
A1 Jasmina Xie
YR 2015
UL http://journal.pda.org/content/69/5/650.abstract
AB The technology transfer of biological products is a complex process requiring control of multiple unit operations and parameters to ensure product quality and process performance. To achieve product commercialization, the technology transfer sending unit must successfully transfer knowledge about both the product and the process to the receiving unit. A key strategy for maximizing successful scale-up and transfer efforts is the effective use of engineering and shake-down runs to confirm operational performance and product quality prior to embarking on good manufacturing practice runs such as process performance qualification runs. We consider key factors to consider in making the decision to perform shake-down or engineering runs. We also present industry benchmarking results of how engineering runs are used in drug substance technology transfers alongside the main themes and best practices that have emerged. Our goal is to provide companies with a framework for ensuring the “right first time” technology transfers with effective deployment of resources within increasingly aggressive timeline constraints.