A major trend in the biologics industry is the emergence of precision medicine approaches to provide potent, targeted therapies for small patient populations. While blockbuster monoclonal antibody therapeutic demand is in the range of metric tons of drug product per year, many next generation biologics have smaller mass demands ranging from tens to a few hundred kilograms. A second trend is the focus on rapid response due to unpredictable market needs or pandemics, as seen with COVID-19. This market evolution highlights a need for flexible manufacturing platforms capable of producing a variety of products instead of a single blockbuster.
Our solution: J.POD®
Just – Evotec Biologics has built a small-footprint, highly automated cGMP manufacturing facility, J.POD, that leverages single use systems and reconfigurable cleanroom pods for maximum flexibility. J.POD can operate clinical or commercial processes in semi- or fully continuous mode with 500-1000L bioreactors. Instead of scaling up, a process can be scaled by bioreactor duration to deliver anywhere from a few kilograms of drug substance to metric tons.
We use an intensified, continuous process platform that connects high-performance, perfusion cell culture with intensified downstream processing. A significant advantage is the opportunity to reduce manufacturing footprint, since a process that operates 24/7 in a connected, continuous manner does not require large processing equipment.
To learn more read the full article on our cGMP manufacturing facility J.POD in the June edition of BioProcess Int.