The efficient development and delivery of high quality therapeutic products necessitates the need for high-throughput process development (HTPD) tools. In recent years, fed-batch process development timelines have been significantly reduced as industry has implemented fully automated mini bioreactor systems such as the ambr® 250 HT.  More recently, as continuous processing for biologics has gained traction, driven by novel technology and economic pressure to significantly improve monoclonal antibody (mAb) production over the standard fed-batch process, more efficient, cost effective, and environmentally sustainable mAb processes are expected. Traditionally, perfusion process development work, typically requires a combination of simulated perfusion in a multi-well or flask format and small-scale stirred tank bioreactor (STR), both of which have drawbacks.  Simulated perfusion experiments can be automated and conducted in high throughput, but are not fully representative of continuous cultures performed in bioreactors with on-line control.  In contrast, STR experiments are labor intensive and time consuming. The established ambr® 250 HT platform has recently been integrated with perfusion capabilities to enable rapid continuous perfusion process development (PD). This work demonstrates initial assessment studies of the automated disposable perfusion bioreactor system for high throughput upstream PD activities, including clone selection, and process optimization. These studies conclude that ambr® 250 perfusion reactors generate equivalent process performance and product quality profiles compared to bench-top bioreactors for a high cell density perfusion process.<br/>

Assessment of ambr® 250 perfusion bioreactor system as a model for high-throughput perfusion process development

2019 Spring National Meeting

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