Raise Your Upstream IQ: Key Considerations For Optimizing Process Development

By Zhou Jiang and Andreas Castan, Cytiva

An increased focus on precision medicines and orphan drugs over traditional blockbuster products means today’s manufacturing facilities and process development capabilities must be equipped to manage the growing diversity across the bioprocessing landscape. This includes greater efficiency and quicker time to market using continuous manufacturing for multiproduct production. The importance of reducing development timelines has always been a goal for drug manufacturers, but the need to establish a rapid response strategy for emergency circumstances intensified greatly with the COVID-19 outbreak. Using an approach like continuous manufacturing would not only improve speed to market, which is more important now than ever, but it would also help with the ongoing effort to cut development and manufacturing costs.

In 2019, the FDA issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing,” in an effort to expand upon its previous guidance on the topic as well as encourage companies to switch from batch manufacturing to continuous. The agency recognizes continuous manufacturing as one of the most important tools for modernizing the pharmaceutical industry. The key enabler for intensified processes are continuous manufacturing techniques, e.g. perfusion, which can, which can maximize product output, minimize a manufacturing footprint, and reduce capital expenses. So, how can you intensify your cell culture processes, in order to keep pace with today’s industry and regulatory expectations?