Jin Yin1, Gan Wei1, Yas Saotome1, and Geoffrey Hodge2. (1) Shire Human Genetic Therapies, 700 Main Street, Cambridge, MA 02139, (2) Xcellerex Inc., 170 Locke Drive, Marlborough, MA 01752
A fully disposable perfusion stirred tank bioreactor system has been developed for the production of therapeutic proteins. The system consists of a disposable stirred tank bioreactor (Xcellerex XDR™) and a disposable centrifugation cell retention device (Pneumatic Scale CentriTech®). A 200 L scale system was evaluated using a human cell line generated for the production of a therapeutic protein. This evaluation run was conducted for 28 days, with a continuous perfusion rate of one bioreactor working volume per day utilizing a culture medium free of animal-derived components. The culture reached a density of 10 million viable cells per mL while cell viability remained higher than 88% throughout the process. Data obtained with the 200 L disposable bioreactor run will be discussed, in comparison to those of non-disposable bioreactor runs.