Jason Gu, Engineer, Genentech Keri Mills, Senior Engineer, Genentech Aimee Lehman, CC Lab Lead, Genentech Paramjit Kaur, Engineer, Genentech Jun Luo, CC Group Lead, Genentech
In the biotechnology/pharmaceutical industry, routine process monitoring typically encompasses intrabatch and interbatch monitoring of cell culture performance (i.e., growth rate, viability) and recovery step yield. Recently, there has been more focus on understanding the impact of variations in raw material sourced from external vendors on process performance. Due to the amount of materials involved in a typical large-scale biologics drug substance manufacturing process, raw material lot tracing is very complex and often difficult to perform consistently across multiple batches. At Genentech's Vacaville manufacturing facility, a programmatic lot trace with comparison to key performance indicators (KPI) in a JMP script was developed to facilitate analyzing the impact of different lots of raw materials. By incorporating this analysis in our routine process monitoring, the impact of raw material variations can be tracked over time, and their effect on our production process can be further quantified, leading to quicker troubleshooting and preventing potential yield loss.