April 16, 2024
Sponsored by Sartorius
The demand for improving global access to innovative, life-saving drugs is rising. This places mounting pressure on biopharmaceutical developers and manufacturers to deliver effective biotherapeutics, such as monoclonal antibodies (mAbs), quickly and cost-effectively. Meeting these ambitious targets requires tools and strategies to support efficient production.
Process intensification approaches hold significant potential to boost productivity in bioprocesses. These methods are widely adopted in upstream processes, increasing the yields entering downstream steps. However, the implementation of similar intensification tools in downstream processes has not kept pace, creating purification bottlenecks. Overcoming these hurdles requires a paradigm shift in how we approach downstream purification by re-imagining chromatography.
In a recent white paper, Sartorius experts present an effective strategy for implementing downstream process intensification in a stepwise manner, illustrated by a case study with Enzene Biosciences. Starting from boosting the productivity of chromatography operations, we offer a tangible example of a gradual approach to building a continuous purification platform using the Resolute® BioSC multi-step chromatography system.
The results demonstrate how–compared to a batch process–a connected downstream process can lead to:
Up to 54% increased productivity and 35% shorter processing times
Reduced facility footprint by >2x
(~16%), as determined by commercial process simulations.
By leveraging the solutions detailed in the white paper, biopharmaceutical manufacturers can learn how to navigate the transition to a connected process to overcome productivity bottlenecks and transform their mAb purification process, regardless of where they are on their intensification journey.
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