ATF Perfusion-based Production Platforms for Biopharmaceuticals at Good Grip – Concept s for Robust Control and Operation

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Continuous Perfusion is comparatively unpopular rather than considered as a first choice production platform for complex biopharmaceutical glycoproteins. Major concerns that have been addressed are mainly related to risk of process failure during long-term operation, complexity and scalability of cell retention devices, supply and definition of consecutive lots and, finally, handling of continuous harvests in downstream processing. We have cleared-up these stereotypes and designed a robust modular perfusion-based production platform for biopharmaceuticals demanding highest quality at industrial scale. Main components of the perfusion platform comprise the application of a robust, scalable perfusion device, sound solutions for on-line biomass and perfusion rate control, as well as the use of a well-characterized continuous product capture and, finally, the fast identification of critical process parameter (CPPs).