Past and Present Strategies, Challenges, and Benefits of Stable Cell Line Development at Genentech

We have previously used a 2-cycle cell line development (CLD) approach (one line for early clinical production and a different line for late clinical and commercial production) to enable rapid entry into initial clinical studies. With the advance of new technologies, we have developed and implemented a 1-cycle CLD platform process that uses the same cell line from Tox all the way through commercial production, yet still allows fast entry into the clinic. This avoids potential comparability challenges associated with cell line changes and provides an opportunity to move from Phase I to Phase III quickly, if needed, for accelerating programs. This presentation will articulate cell line development strategies, throughputs, challenges, and benefits of past and current CLD processes.