Genentech/Roche faced the business challenge of supporting the launch of a robust pipeline of new products while sustaining high demand for existing commercial products. This drove evaluation of their existing production network on how to best achieve a flexible overall solution to deliver the pipeline while ensuring supply to patients. As such Genentech/Roche designed and constructed a facility at their Oceanside CHO drug substance site, utilizing existing shell space to deploy more product launch capacity. The target facility capability was to enable drug substance production for two new product launches per year with minimal lead time and tech transfer cost for platform monoclonal antibody processes. This online session explains how the Genentech team approached the task to design and construct this flexible facility, in particular, covering how the process, piping/ equipment, and automation aspects were devised. We will also address considerations for future capabilities of the facility in terms of capacity, higher product titers, and novel process requirements.
Eric Fallon is responsible for Global Biologics Manufacturing Sciences and Technology (MSAT), Drug Substance at Roche/Genentech. He leads a Global MSAT team that is responsible for providing ongoing technical support of Roche’s commercial biologics drug substance (DS) manufacturing across the internal and external manufacturing network. Eric also chairs the Roche Biologics Drug Substance Technical Council, which is tasked with aligning the global Roche DS Network (internal and external) on implementation of globally impacting new technologies and improvement of current bioprocess technologies. Prior to his current role, Eric was responsible for the Technology function at Genentech’s Oceanside Product Operations, which comprised leadership of process technology transfers into the Oceanside site, providing technical support for ongoing biologics drug substance manufacturing, and coordination of process and technology improvement efforts in collaboration with the Genentech/Roche Pharma Technical Operations network.
Elizabeth Danbe is a Senior Engineer in the Global Pharm Technical Engineering group at Genentech/Roche. She is currently the Automation Sub-PM for the Genentech Oceanside Purification Expansion project. Prior to her current role, Elizabeth was the technical lead and PM for the Genentech Hillsboro – Batch Record Review by Exception project. She began her career in the Genentech South San Francisco Pilot Plant supporting CHO and E.coli, fermentation and purification process development. Elizabeth received her M.S. in Electrical Engineering from Purdue University, M.B.A from Indiana University and has a B.S. in Electrical Engineering from University of California-Santa Barbara.