In this presentation, we show the feasibility of monoclonal antibody (MAb) production in fed-batch processes using the single-use Xcellerex™ XDR-200 stirred-tank bioreactor system and a satellite ReadyToProcess WAVE™ 25 rocking bioreactor system. Cell expansion was performed in a 15 L rocking bioreactor culture to seed a 200 L stirred-tank bioreactor culture. To compare the performance of ReadyToProcess WAVE 25 with that of XDR-200, 7 L of the 200 L culture was transferred to a parallel ReadyToProcess WAVE 25 system to a total culture volume of 10 L (satellite run). MAb yields from the parallel productions were 5.0 and 4.9 g/L for XDR-200 and ReadyToProcess WAVE 25, respectively. Furthermore, the metabolite and product quality profiles were very similar in both bioreactor cultures. Together, the ReadyToProcess WAVE 25 and Xcellerex XDR bioreactor systems provide a powerful solution for robust, scalable production of recombinant proteins in a single-use format. In addition, the ReadyToProcess WAVE 25 is a versatile tool that can be used for both seed-train applications and process development.

Efficient, high-titer monoclonal antibody production in a fed-batch process using single-use stirred-tank and rocking bioreactor systems

249th National Meeting (2015)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.