From PC to CPV: Preserving Process Knowledge Through Late-Phase Tech Transfer

Want to know what it really takes to protect a drug substance process's scientific integrity when it moves to a new manufacturing site? This executive summary, featuring the insights of Danielle Wittenwyler, PhD, Associate Director of Process Development, Drug Substance Lifecycle at Catalent, examines how late phase tech transfer can preserve process characterization (PC) as active scientific knowledge rather than static documentation. It outlines the common sources of transfer risk and describes a risk-based approach to bridging studies. The piece explains how preserved process knowledge supports more meaningful process validation (PV) and continued process verification (CPV) throughout the product lifecycle